Careers with Cirtec – Medical Device Design, Manufacturing, and Finished Device Assembly

We actively seek creative candidates in the fields of sales, program management, mechanical engineering, quality engineering, electronics and software engineering, process engineering, and manufacturing engineering, including technicians, assemblers and supervisors. Our employees have the satisfaction of knowing that the work they do is helping patients live better, longer lives, and they take pride in the work they perform for one of the industry’s top medical device companies. Here at Cirtec, every employee is highly valued and crucial to our success. We place a high value on performance excellence, career development, safety, rewards and communication.  If you value teamwork, client focus, accountability and innovative thinking, Cirtec has rewarding opportunities where you can make a difference! We want to be your career choice in the Medical Device Industry.  Cirtec is an equal opportunity employer and does not discriminate based on race, gender, ethnicity or sexual orientation.

To view all current positions and apply online, visit the Cirtec Career Site or review the positions below and click “Apply Now”.

Opportunities in Brooklyn Park, MN

Sr. Engineering Technician

Summary:

The Sr. Technician, Engineering is primarily responsible for utilizing state of the art equipment for the development of life changing medical devices.  The ideal candidate will be comfortable operating a variety of equipment including, but not limited to; lasers, injection molders, reflow machines as well as an array of test equipment while adhering to the quality requirements of the company. In addition, this position will work with the design and process teams to ideate, create, and build first prototypes. This individual is essential in the maturation of these prototypes and their progress through the development.  Lastly, the Sr. Technician, Engineering must feel comfortable providing candid feedback to the development team to ensure success in later phases of the program at a more senior level.

Responsibilities

  • Assemble development prototypes in a timely manner, whether independently or coordinating with a larger team of operators and technicians.
  • Provide candid feedback to engineering team when designs and/or processes can be improved.
  • Document settings, assembly techniques, etc. in a laboratory notebook using good documentation practices.
  • Draft initial process flows and manufacturing procedures.
  • Small scale Engineering Change Order creation and execution.
  • Perform training to the assembly team when programs mature in the development phases.
  • Perform DVT in the design lab.
  • ECN creation and execution.
  • Place an order (purchase req) for materials through purchasing dept.
  • Maintain compliance to procedures and regulatory requirements.
  • Assist in training employees on equipment and assembly skills.
  • Interact effectively and assist engineering in improving quality and solving problems.
  • Ability to diagnose and solve problems with jobs in a timely manner.
  • Reliable, consistent and punctual attendance is an essential function of the job
  • Other duties as required.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • 3-7 years’ experience in the engineering/manufacturing environment for medical devices.
  • Strong drive to learn, share and teach.
  • Understanding of and experience with mechanical equipment.
  • FDA, cGMP principles and practices, (ISO 9001, ISO 13485).
  • In-depth understanding of one or more manufacturing processes is a plus.
  • Familiarity with Pro-E / CREO and or SolidWorks is preferred.
  • Strong computer skills associated with Microsoft software.
  • Ability to interpret technical drawing, blueprints, specifications, and illustrations.
  • Must be able to read, write and speak fluent English.
  • Excellent reading, writing, communication, and organizational skills.
  • Maintains performance with changing priorities under minimal supervision.
  • Possess strong team collaboration skills.
  • Must be able to make clear and accurate decisions.
  • Strong desire to learn and apply new technology.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Engineer II, Manufacturing

Summary:

This position is primarily responsible for maintaining, developing, and implementing cost-effective manufacturing processes and methods in accordance with customer product specifications for components and assemblies to Class III medical device quality standards. Manufacturing Engineers document processes and could implement ideas or solutions to improve assembly operations which may include development of tooling/fixturing as needed to accomplish this task.

Responsibilities

  • Implement, plan, and execute continuous improvement projects for cost reduction, quality improvements and efficiency from conception to fully established production.
  • Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance.
  • May help product development with the manufacturing launch of new products including evaluating yield targets, run rates, training needs and quality results.
  • Prepare engineering change orders and coordinates the deployment of changes including training Operations team members.
  • Perform product and process analysis for cost reduction, quality improvement and improved efficiency through scrap models and weekly project updates with required actions.
  • Utilize tools associated with risk management (PFMEA/Hazard Analysis) to identify potential risks and the associated corrective actions.
  • Support required equipment installation qualifications, process validations, and retroactive legacy qualifications or validations.
  • Troubleshoot processes when defects occur. Help to determine root cause and implement effective containment and countermeasures.
  • Help to lead Non-Conforming Material Report (NCMR) or customer complaint investigations.
  • Develop, test, and provide ROI cost justification for various tools or equipment recommended for manufacturing.
  • Disposition non-conforming products and develop re-work procedures.
  • Communicate with customers regarding process improvements and requested production changes.
  • Represent manufacturing on cross functional teams.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Attends, schedules and may lead project meetings to evaluate current and future process initiatives.
  • Arrange project meetings with customers to discuss current and future process improvements and development initiatives.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • A Bachelor’s degree in an engineering discipline, minimum 3 years appropriate work experience.
  • Willingness to travel, if required.
  • Must maintain high ethical standards.
  • Must demonstrate good organizational skills.
  • Must be able to read, write and speak fluent English.
  • Experience in an engineering/manufacturing environment with mechanical, tool design, and manufacturing processes preferred.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications & illustrations.
  • Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information.
  • Ability to learn and apply new technology.
  • Technical report preparation and formal presentation skills.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Manufacturing Engineer

Summary:

This position is primarily responsible for developing and implementing robust cost-effective manufacturing processes and methods in accordance with product specifications and Class III medical device quality standards.  This position recommends and implements improvements to sustained production processes, methods and controls; as well as coordinates the launch of new products into pilot production.

Responsibilities:

  • Improves manufacturing processes, methods and controls for cost reduction, quality improvements and efficiency for both sustained and new products.
  • Prepares engineering change orders and coordinates the deployment of changes including training operation team members.
  • Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance for both sustained and new products.
  • Coordinates the manufacturing launch of new products including establishing yield targets, run rates, training needs and evaluating results.
  • Develop and qualify various tools and equipment required for manufacturing processes.
  • Performs product and process analysis for cost reduction, quality improvement and improved efficiency.
  • Utilizing tools associated with risk management (e.g. PFMEA) to identify potential risks and the associated corrective actions.
  • Supporting required equipment qualification and process validations (IQ, OQ and PQ).
  • Troubleshoot manufacturing processes when defects occur.  Determine root cause and implement effective containment and countermeasures.
  • Disposition non-conforming products and develop re-work procedures.
  • Communicate with customers regarding process improvements and production changes.
  • Represent manufacturing on cross functional teams.
  • Lead Kaizen events and drive continuous improvement efforts.
  • Provide new ideas for process improvements, design new fixtures and optimize automation process
  • Take charge of the transfer of new products from R&D to commercial manufacturing
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor’s degree in Engineering or related field.
  • Knowledge of manufacturing and assembly processes.
  • Excellent verbal and written communication skills.
  • Fluency in English.
  • Minimum 2-5 years of experience with Class II or III Medical devices, FDA standards, ISO 13485 and GMP principles.
  • Leadership skills, including ability to organize, clarify and influence others.
  • Must be able to read blueprints and interpret technical specifications and illustrations.
  • Association with supporting documents including, ECN’s, process deviation, non-conformances, stop shipment notifications and all associated quality related documents.
  • Strong computer skills associated with MS Office suite, Minitab and SolidWorks a plus.
  • Experience associated with continuous improvement activities, including participations and/or facilitating Kaizen events using lean manufacturing principles.
  • The ability to understand a range of engineering functions and procedures.
  • Interpersonal, presentation and communication skills.
  • The capacity to work well under pressure and take on new challenges.
  • Organizational and time management skills.
  • Project management skills and the ability to work to tight deadlines.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None/PPE

WORKING ENVIRONMENT

Work is performed in an office and manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. NPI Engineer

Summary:

The Sr NPI. Engineer is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities

  • Attends and arranges project meetings to discuss current and future design and development initiatives
  • May serve as a primary contact with clients on projects of moderate complexity
  • Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner
  • Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Track and communicate project status, plans, issues, timelines, action items, and budgets
  • Provide guidance and direction to coworkers on areas of technical expertise
  • Troubleshoot production processes as required
  • Evaluate and select appropriate test methods for product requirements
  • Responsible for the following project inputs:
    • Feasibility builds, documentation, and testing
    • Equipment selection, process development and documentation
    • Device Verification samples and testing
    • Operator training
    • Process Failure Mode Effects Analysis
    • Clinical builds
    • Process Validation
  • Involvement in the full design, development, and validation requirements of projects, including:
    • Product design and specification creation, including mechanical and electrical components, assemblies, and packaging
    • Materials sourcing and device prototyping
    • Design verification and validation activities, including data for regulatory submission
    • Manufacturing transfer and support of existing product lines as applicable
  • Reliable, consistent and punctual attendance is an essential function of the job
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • A Bachelors’ degree in an engineering discipline with 5 years of relevant experience
  • Experience in an engineering/manufacturing environment with a mix of mechanical design, tool design and manufacturing process experience.
  • Willingness to travel, if required.
  • Must maintain high ethical standards
  • Must demonstrate good organizational skills.
  • Ability to train new engineering employees on project engineering activities and Cirtec policies and procedures.
  • Must be able to read, write and speak fluent English.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications, illustrations, and written documents.
  • Strong analytical skills, must be able to obtain and evaluate secondary research information.
  • Ability to learn and apply new technology.
  • Moderate knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics.

WORKING ENVIRONMENT 

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. NPI Quality Engineer

Summary:

The Senior NPI Quality Engineer will develop, establish, and maintain quality engineering methodologies, systems and practices which meet customer and regulatory requirements. This role will be focused on providing quality engineering support to the new product development process, operations/production, and quality systems. This individual will also serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support site and corporate quality goals and priorities.

Responsibilities

  • Provide Quality Engineering support for engineering product development, or sustained manufacturing.
  • Provide Quality Project Management support as needed for product transfers from development to validation to production.
  • Verification/Validation System Owner responsible for the development and management of the verification/validation master plan along with the verification/validation determination.
  • Develop and maintain Standard Operating Procedures.
  • Develop and maintain project Quality Plans for assigned projects.
  • Develop protocols, perform statistical analyses, and write reports for validations and formal product/process development, which requires quality-engineering involvement.
  • Support the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols to ensure compliance with the Quality System.
  • Provide Quality Engineering support for engineering/manufacturing.
  • CAPA (Corrective and Preventative Action) system owner or support responsible for the support of the corrective action system and procedures.
  • Interact with customers and suppliers to resolve CAPA and complaint investigations.
  • Provide Quality Support for the disposition of material via NCRs.
  • Support supplier quality activities including vendor approval and maintaining and assessing vendor performance data (i.e. SCAR/on time).
  • Review and document procedure changes for quality requirements and compliance with the quality system.
  • Develop quality systems and procedures as needed.
  • Audit support for third party audits, customer audits and internal audits.
  • Support the implementation of continuous improvement initiatives.
  • Develop and maintain production quality control plans.
  • Initiate and maintain SPC (Statistical Process Control) for production processes.
  • Lead or support FMEA (Failure Modes & Effects Analysis), and DOE (Design of Experiment) as applicable.
  • May serve as backup to Quality Manager.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor of Science, preferably in an engineering discipline.
  • Minimum experience in medical/manufacturing environment: 5years.
  • Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
  • Must possess excellent verbal communication, organizational and management skills.
  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access. Minitab experience desirable.
  • Must be able to read, write and speak fluent English
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement
  • Must be able to analyze and process information; promote Process Improvement, Developing Standards, Managing Processes, Manufacturing Methods and Procedures; and Supports Innovation.
  • Willingness to travel, if required.

WORKING ENVIRONMENT 

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. NPI Engineering Technician

Summary:

This position is primarily responsible for developing and improving assembly operations in an effort to improve productivity, yield and process flow. Must provide excellent trouble shooting ability on equipment and assembly fixturing. Assist NPI Engineering to develop new processes, documentation, perform experiments and develop tooling/fixturing as needed.

Responsibilities:

  • Develop processes and documentation in support of new and existing components and assemblies to include clean room assembly, machining, coiling, and laser processing support.
  • Active participation in improving quality and processes for the products we manufacture. Focusing on the clean room.
  • Understand and promote good manufacturing practices (GMP) including all clean room related requirements.
  • Be a key trainer for employees on new processes and products being transferred from Engineering to Production.
  • Interact effectively and assist engineering in improving quality and solving problems.
  • Work with tooling engineer to design fixtures for procedures developed.
  • Show self-motivation to optimize job performance on a continual basis.
  • Evaluate alternative manufacturing methods.
  • Process basic ECO’s to existing drawings, tooling and fixtures using Pro-E.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • 10+ years’ experience in a medical device clean room assembly environment. Includes, but not limited to working with different bonding agents, such as epoxies, UV adhesives & silicones. Also, familiarity with operations such as laser welding, crimping, swaging, thermoforming, annealing and general mechanical assembly.
  • Excellent working knowledge of blueprint and geometric tolerances.
  • Ability to diagnose and solve problems with jobs in a timely manner.
  • Strong Problem solving and process validation experience.
  • “Job Shop” experience running all types of CNC machines is a plus, but not required.
  • Willingness to travel, if required

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

NPI Quality Technician

Summary:

The Quality Technician is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, and quality systems.

Responsibilities:

  • Complies with company, quality and safety standards, policies, and procedures.
  • Under Quality Engineer (QE) oversight, assist with qualification and validation (IQ, OQ, PQ).
  • Compile and analyze statistical data to assess process capabilities and control processes.
  • Develop inspection test methods and draft inspection procedures with QE oversight.
  • Handle Calibration Management including new and current equipment that requires calibration, calibration supplier management and out of tolerance reporting as required.
  • Handle Environmental Monitoring Management including collecting samples, testing, entering and trending results and out of tolerance reporting as required.
  • Support the nonconforming material reporting process including verifying nonconformance descriptions, evaluating to determine root cause of the nonconformance and proposing final disposition of nonconforming product.
  • Review and approve inspection and device history records as required.
  • Support CAPA process by assisting in the investigation and implementation of corrective action.
  • Identify areas of improvement and participate in continuous improvement projects.
  • Perform Gemba walks and participate in 5S activities.
  • Support QEs and other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High School diploma.
  • 1-3 years of experience in manufacturing environment (preferred requirement – Medical Device industry).
  • Knowledge of medical device regulations (21CFR820, ISO 13485).
  • Technical training and/or experience in related field.
  • Working knowledge of basic inspection processes and measurement practices.
  • Must be able to read, write and speak fluid English.
  • Ability to read and interpret assembly drawings and specifications.
  • High proficiency in use of computer systems using standard business software: Outlook, Word, PowerPoint, Excel, MRP/ERP systems.
  • Strong verbal and written communication skills.
  • Ability to work with a wide variety of functional areas including but not limited to Program Management, R&D, Manufacturing and QA as required accomplishing results with minimal guidance.
  • Excellent organization and time management skills with an ability to think proactively and prioritize work.
  • Flexible and able to accommodate changing priorities and directions.
  • Willingness to travel, if required.

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

NPI Operator Assembler I

Summary:

This position is primarily responsible for assembling a range of components into finished goods across one or more production lines ensuring standard documentation, quality, and production rates are met.

Responsibilities:

  • Complies with company, quality and safety standards, policies, and procedures.
  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Has the responsibility of following established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from upper-level operators assigned to that cell.
  • Will be proficient in the task of loading components into product specific tools.
  • Primary function of assisting production operators and technicians engaged in processing and product fabrication.
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • May perform weld operations.
  • Must accurately document all work performed on inspection reports and customer travelers.
  • Assists in packaging of finished goods as needed.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or General Education Degree (GED) is required.
  • 1 year experience in a manufacturing environment preferred but not required.
  • Must be able to read, write and speak fluent English.
  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail.
  • Knowledge of ISO & FDA requirements a plus.
  • Experience with LEAN manufacturing a plus.
  • Ability to work in environment subject to fluctuations in heat, humidity, fumes, odors, dust, and noise.
  • Ability to provide detailed information to assist sustaining engineering in determining root cause in order to identify the appropriate corrective action.
  • Good interpersonal skills to establish and maintain cooperative and effective working relationships.
  • Good written and verbal communication skills.
  • Willingness to travel, if required.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

NPI Operator Assembler II

Summary:

This position is primarily responsible for operating workstations and associated systems used in the manufacturing of products sold to our customers. This position is expected to work with lower-level Operators along with higher level Technicians to effectively meet or exceed expectations for product quality and production rates. In this position they must have a basic knowledge of how to set up and operate workstations, perform visual and dimensional inspections needed to manufacture the products at Cirtec.

Responsibilities:

  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Has the responsibility of following established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from upper-level operators assigned to that cell.
  • Will be proficient in the task of loading components into product specific tools.
  • Primary function, processing, and product fabrication.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • Performs basic workstation set up and troubleshooting tasks.
  • Performs various dimensional inspection using specific gauges, dimensional inspection systems, verniers and micrometers.
  • May perform weld operations.
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions.
  • Provides direction within the manufacturing cell to associates assigned to assist them.
  • Assists Quality Control with inspection duties as required.
  • Recognizes quality issues and communicates these issues to Quality and/or Supervisor.
  • Must accurately document all work performed on inspection reports and customer travelers.
  • Assists in packaging of finished goods as needed.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or General Education Degree (GED) is required.
  • 3-5 years’ experience in medical device industry, preferred but not required.
  • Be able to read, write and speak fluent English.
  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail.
  • Meets all requirements of Operator/Assembler I.
  • Knowledge of how to set up and operate workstations.
  • Ability to provide information to engineers for determining root cause in order to identify the appropriate corrective actions.
  • Knowledge of performing visual and dimensional inspections.
  • Strong interpersonal skills to establish and maintain cooperative and effective working relationships.
  • Willingness to travel, if required.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. NPI Operator Assembler

Summary:

This position is primarily responsible for assembling product, associated systems, and basic operating of laser used in the manufacturing of products sold to our customers. This position is expected to work with and assist in the training of lower-level operators to effectively meet or exceed expectations for product quality and production rates. It is also expected that in this position there will continue to build their skills with Technicians along with taking tasks and direction from the Engineering departments. In this position you must be proficient in setting up and operating workstations perform visual and dimensional inspections needed to manufacture the products at Cirtec.

Responsibilities:

  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Has the responsibility of following established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from Team Lead/Supervisor.
  • Will be proficient in the task of loading components into product specific tools.
  • Primary function, processing, and product fabrication.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • Performs complex workstation set up and troubleshooting tasks.
  • Performs various dimensional inspection using specific gauges, dimensional inspection systems, verniers and micrometers.
  • Provides training on processes to team members
  • Has the standard skills of operating manufacturing workstations including most laser systems used in the manufacture of products sold to our customers.
  • Proficient in the operation of computerized motion controllers.
  • Knowledge of welding operations.
  • Ability to perform workstation set up requirements for any type of processing job using existing tooling and established parameters.
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions.
  • Provides direction within the manufacturing cell to associates assigned to assist them.
  • Assists Quality Control with inspection duties as required.
  • Possesses the ability to accurately follow operating manuals, maintenance instructions, Standard operating procedures & work instructions.
  • Operate effectively and maintain professionalism in an environment of deadlines and high workloads and adjust schedule or work hours to meet changes in priorities.
  • Performs additional duties as required under the direction of the Production Team Leader/Supervisor.
  • Responsible for recognizing quality issues and communicating issues to the Quality and/ or Production Supervision.
  • Acts as a resource during audits or customer visits for questions and answers or practical demonstrations.
  • When assisting upper-level Technician or Engineer accurately document development activities in a lab notebook.
  • Ability to provide input to Engineering and upper-level Technicians in regard to tool design and/or troubleshooting processes.
  • Assists in ensuring the accuracy of Process Control Documents, Parameter Sheets, Work Instructions, and Standard Operating Procedures.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or General Education Degree (GED) is required
  • 4-6 years’ experience in medical device industry or equivalent training preferred.
  • Be able to read, write and speak fluent English. Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail
  • Knowledge of ISO & FDA requirements a plus.
  • Experience with LEAN manufacturing a plus.
  • Ability to work in environment subject to fluctuations in heat, humidity, fumes, odors, dust, and noise.
  • Ability to provide detailed information to assist sustaining engineering in determining root cause in order to identify the appropriate corrective action.
  • Strong interpersonal skills to establish and maintain cooperative and effective working relationships.
  • Good written and verbal communication skills.
  • Meets all requirements of Operator/Assembler Il
  • Knowledge of how to set up and operate workstations.
  • Moderate computer skills, including the MS Office suite.
  • Must be able to interpret technical drawings, blueprints, specifications & illustrations.
  • Strong analytical skills and must have the ability to obtain secondary research information from the Internet or alternate sources.
  • Ability to learn and apply new technology.
  • Technical report preparation
  • Ability to provide information to engineers for determining root cause in order to identify the appropriate corrective actions.
  • Knowledge of performing visual and dimensional inspections.
  • Willingness to travel, if required.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Industrial Engineer I

Job Summary

The Operational Excellence program seeks to minimize waste and variation through Lean and Six Sigma approaches leading to improved production processes and systems that operate at high efficiency levels. The Industrial Engineer (IE) is responsible for identifying and leading execution of a wide range of Continuous Improvement projects.  The IE leads, facilitates, executes, and manages team training initiatives and projects.  The IE will utilize knowledge of COGs, gross margin, facility design, material handling equipment, labor management, staff planning and project management to identify, quantify, prioritize and recommend improvement projects that align with the Operational Excellence team charter and organizational goals and objectives.

Responsibilities

  • Participates in identification and planning of department goals implementation of initiatives intended to improve quality, cost and delivery.
  • Serves as an engaging and collaborative teacher/trainer providing internal standardized lean training and consulting support for Lean & Six Sigma tools, data mining and presentation with heavy emphasis on MS Excel.
  • Supports the philosophy of waste reduction through implementation of Lean and Six Sigma approaches within the organization.
  • Utilizes tools and methodologies including, but not limited to time studies, line balancing, setup time reductions, line layout creation, flow improvement, 5S, standard work, visual factory improvements and accountability systems.
  • Collaborates with cross-functional teams.
  • Evaluates, designs, and implements new production line and facility layouts.
  • Leads and/or facilitates A3 projects and teams.
  • Collaborates with others on Key Process Indicator development and implementation.
  • Seeks out continuous improvement opportunities, weighs their value based on benefit, investment, and risk, and prioritizes work accordingly.
  • Participates in project work to help customers and operators achieve sustainable results.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications

  • BS degree required. Industrial Engineering highly preferred.  Advanced degree a plus.
  • 2-5 years manufacturing experience, preferably in medical device and/or machining.
  • Strong MS Excel knowledge.
  • Six Sigma or Lean Certification (ASQ or IASSC) is a plus.
  • Strong analytical, problem solving and project management skills.
  • Must be a learner; adaptable to accept new changes in the field of lean manufacturing and desire to remain knowledgeable regarding the latest developments in field.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to influence and engage others to accomplish projects.
  • Must be able to read, write and speak fluent English.
  • Must be a clear communicator of ideas in both written and oral forms to all levels of the organization.
  • Strong organizational abilities; can multitask and prioritize to meet deadlines in timely manner.
  • Ability to travel to other sites (approximately 5-10%).What We Offer

Working Environment

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO Statement

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Systems Engineer

About the Company

More than just another design shop or contract manufacturer, Cirtec offers a uniquely comprehensive range of vertically integrated capabilities. Cirtec specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization.

Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers’ devices to market.  If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you!

You are part of: 

The engineering team consisting of other engineers with diverse backgrounds and expertise.  The Engineering team works in close collaboration with Operations, R&D, and Purchasing. You will be involved in the design, development, documentation and validation of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Job Summary

The Senior Systems Engineer will be responsible for system-level development and implementation of electronic and software designs for Class II and III medical devices. The Sr. Systems Engineer will work with a multi-disciplinary engineering team including software, electrical and mechanical hardware engineers and all other functions of the company to ensure high quality and on-time product introductions. This team player will have experience with multi-tasking in a high energy fast paced environment. The person needs to have strong self-starting qualities to independently manage coordination of multiple projects to ensure timely and successful completion. Must be enthusiastic, positive, even tempered and have strong skills in areas of dependability, interpersonal relationships, and communication.

Responsibilities

  • Create requirements, engineering specifications, tests during the life cycle of the product development.
  • Applies medical development standards, such as IEC 60601-1, 62304, 60601-1-2, ISO 14708-1, 14708-3, ISO 13485.
  • Ensure that all hardware and software requirements and specifications are being met, and that all elements are being developed to maximize performance, reliability and serviceability within the constraints of the project schedule and budget.
  • Perform detailed design analysis and conduct regular design reviews with hardware and software engineering teams.
  • Collaborate with program managers to create and manage development plans and project plans related to electronic and software systems development.
  • Lead and contribute in creation of risk management documentation, including Failure Mode Effects Analysis.
  • Develop and maintain documentation (e.g. specifications, designs, test plans and reports, etc.) required for medical product Design History Files. Manage and assist in creation of manufacturing process instructions, bills of material, quality inspection, and related documentation.
  • Create, review test software requirements, architecture, develop and executing the test code.
  • Knowledge of Quality Management System principles and methodology.
  • Participate in product development meetings and software/hardware design and risk analysis reviews.
  • Specify and assemble hardware for tests.
  • Maintain design history file and participate in periodic phase reviews.
  • Create reports to the stakeholders and create test logs.
  • Provide inputs to the team in order to improve the medical device design and test outcomes.
  • Use a thorough, systematic, open approach to problem-solving.
  • Reliable, consistent and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications

  • BS in Electrical Engineering, Computer Engineering, or Systems Engineering or in an equivalent engineering discipline.
  • Minimum of 3 years’ experience in a regulated development environment.
  • Meticulous attention to detail, including ability to maintain accurate records and traceability.
  • Experienced with Quality Control principles and methodology.
  • Good Communication and interpersonal skills.
  • Analytical reasoning and problem solving.
  • Experience in developing requirements, engineering specifications, procedures.
  • Team player and goal oriented.
  • Knowledge of Agile development methodologies (Scrum, Kanban).
  • Excellent oral, written, and presentation communication skills.

PREFERRED QUALIFICATIONS

  • Engineering experience with active and passive implantable devices and peripherals for Class III medical devices.
  • SysML, UML and MBSE.
  • INCOSE ASEP or CSEP.
  • JAMA Product Development Documentation Management.
  • Experienced in electronics: analog, power and digital, oscilloscopes, general electronic test equipment.

What We Offer

  • A fast-paced work environment
  • Clean, and well-lit production areas
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives, and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a company match

Working Environment

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO Statement

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Process Development Engineer

About the Company

More than just another design shop or contract manufacturer, Cirtec offers a uniquely comprehensive range of vertically integrated capabilities. Cirtec specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization.

Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers’ devices to market.  If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you!

You are part of: 

The engineering team consisting of other engineers with diverse backgrounds and expertise.  The Engineering team works in close collaboration with Operations, R&D, and Purchasing. You will be involved in the design, development, documentation and validation of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Job Summary

The Senior Process Development Engineer position is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities

  • Attends and arranges project meetings to discuss current and future design and development initiatives.
  • May serve as a primary contact with clients on projects of moderate complexity.
  • Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
  • Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations. with required actions. Track and communicate project status, plans, issues, timelines, action items, and budgets.
  • Provide guidance and direction to coworkers on areas of technical expertise.
  • Troubleshoot production processes as required.
  • Evaluate and select appropriate test methods for product requirements.
  • Responsible for the following project inputs:
    • Feasibility builds, documentation, and testing
    • Equipment selection, process development and documentation
    • Device Verification samples and testing
    • Operator training
    • Process Failure Mode Effects Analysis
    • Clinical builds
    • Process Validation
  • Involvement in the full design, development, and validation requirements of projects, including:
    • Product design and specification creation, including mechanical and electrical components, assemblies, and packaging
    • Materials sourcing and device prototyping
    • Design verification and validation activities, including data for regulatory submission
    • Manufacturing transfer and support of existing product lines as applicable
  • Reliable, consistent and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • A Bachelors’ degree in an engineering discipline with 5 years of relevant experience.
  • Experience in an engineering/manufacturing environment with a mix of mechanical design, tool design and manufacturing process experience.
  • Willingness to travel, if required.
  • Must maintain high ethical standards
  • Must demonstrate good organizational skills.
  • Ability to train new engineering employees on project engineering activities and Cirtec policies and procedures.
  • Must be able to read, write and speak fluent English.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications, illustrations, and written documents.
  • Strong analytical skills, must be able to obtain and evaluate secondary research information.
  • Ability to learn and apply new technology.
  • Moderate knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics.

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Systems & Software Engineering Manager

Summary:

The Sr. Manager, Systems & Software Development will be responsible for leading the systems and software engineering functions for Class II/III medical device development programs. You will be an integral member of our product development team and will be responsible for providing leadership to our team of highly skilled engineers.

Responsibilities:

  • Lead, and serve as high-level individual contributor in, product development of Class 2/3 active implant systems and complex electromechanical devices
  • Lead and grow a team of skilled software engineers and systems engineers, and provide guidance and mentorship to direct reports
  • Lead and guide systems engineering team in creation of system architecture design, identify interfaces between sub-systems, development and management of product requirements and test specifications based on customer needs, applicable regulatory standards and design control requirements
  • Lead and guide software engineering team to specify, implement and verify embedded software, firmware and other software applications for the product
  • Serves as the principal technical contact with the customers and communicates directly with customers to understand project / product needs, and present technical updates, risks and issues
  • Work cross functionally with program management, quality, manufacturing, regulatory and other engineering teams to manage product design, risk management and system integration activities
  • Lead development and execution of engineering-level and verification testing, including coordination and management of external test houses
  • Lead development and implementation of off-the-shelf and custom ATE and other test systems for design verification and in-process testing during production
  • Participate in technical design reviews and development phase end reviews
  • Collaborate with program management to create and manage development plans and project plans related to software and systems development
  • Collaborate with cross-functional team to manage creation and maintenance of Design History file per Cirtec procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements
  • Research market and competition on an ongoing basis to ensure that Cirtec has cutting edge technologies and capabilities
  • Collaborate with Business Development and Applications Engineering teams to communicate Cirtec’s capabilities to new customers and assist in generation of proposals and quotes
  • Reliable, consistent and punctual attendance is an essential function of the job
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BS or advanced degree in Computer Science, Computer Engineering, Electrical Engineering or an equivalent engineering discipline
  • 10+ years’ experience developing medical devices and 5+ years’ experience leading and/or managing engineering teams
  • Experience with development of active implantable or neuromodulation systems highly preferred
  • Demonstrated expertise in systems and software design and implementation
  • Experience and demonstrated expertise in formal systems engineering methodologies (e.g.: system architecture development and requirements management)
  • Familiarity with key medical device regulatory standards, for e.g. IEC 60601, IEC 62304, etc.
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Principal Electrical Engineer

About the Company

More than just another design shop or contract manufacturer, Cirtec offers a uniquely comprehensive range of vertically integrated capabilities. Cirtec specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization.

Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers’ devices to market.  If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you!

You are part of: 

The engineering team consisting of other engineers with diverse backgrounds and expertise.  The Engineering team works in close collaboration with Operations, R&D, and Purchasing. You will be involved in the design, development, documentation and validation of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Job Summary

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably and cost-effectively.

The Principal Electrical Engineer will be responsible for design and development of electronic systems as part of novel Class II and III medical devices.

Responsibilities

  • Develop and implement electronic circuit designs for medical devices, including designs for wireless sensors, wireless communication, embedded control, wireless charging, battery systems and power management
  • Lead schematic design and layout of printed circuit assemblies using computer-assisted design (CAD) software tools, breadboard and prototype development, testing and troubleshooting
  • Design, calibrate and characterize implantable wireless communication (link budget, antennas, communication scheme) for active implant devices
  • Design and lead the construction of electronic test equipment for use in development and manufacturing
  • Generate specifications, technical drawings, and other relevant design documentation to ensure that electronic designs conform to customers product requirements and applicable standards
  • Collaborate with software engineers to specify, test, and verify embedded software in the system
  • Lead development of electronics for platform-based active implant medical devices and assist business development team in estimation of labor and materials costs
  • Build, test, debug, and maintain configuration of breadboards and prototype assemblies
  • Develop test methods and protocols, and execute prototype testing and formal design verification
  • Participate in the development of quality inspection and manufacturing process instructions for PCBs and other electronic assemblies

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications

  • Bachelor’s degree in Electrical or Electronics Engineering. Advanced degree preferred.
  • Minimum 10+ years of experience in development of electronic products and circuits
  • Minimum of 5 years of experience in a regulated development environment preferably medical.
  • Experience providing technical leadership during customer engagements is required.
  • Ability to direct and mentor other designers is required
  • Ability to lead design projects is required
  • Ability to analyze product proposals and identify critical parameters is required
  • Ability to map out schedules, resources, and partition work for new projects
  • Ability to architect new innovative circuits
  • Ability to conduct detailed design reviews and customer facing design reviews
  • Expertise in electronic design automation tools: e.g.: PCB design (Altium preferred), schematic capture, analog and digital circuit simulation, tolerance analysis
  • Ability to write C/C++ code for embedded microprocessors is preferred
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral

What We Offer

  • A fast-paced work environment
  • Clean, and well-lit production areas
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives, and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a company match

Working Environment

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO Statement

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Process Development Engineer

About the Company

More than just another design shop or contract manufacturer, Cirtec offers a uniquely comprehensive range of vertically integrated capabilities. Cirtec specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization.

Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers’ devices to market.  If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you!

You are Part of:

The engineering team consisting of other engineers with diverse backgrounds and expertise.  The Engineering team works in close collaboration with Operations, R&D, and Purchasing. You will be involved in the design, development, documentation and validation of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Job Summary

The Senior Process Development Engineer position is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities

  • Attends and arranges project meetings to discuss current and future design and development initiatives
  • May serve as a primary contact with clients on projects of moderate complexity
  • Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner
  • Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Track and communicate project status, plans, issues, timelines, action items, and budgets
  • Provide guidance and direction to coworkers on areas of technical expertise
  • Troubleshoot production processes as required
  • Evaluate and select appropriate test methods for product requirements
  • Responsible for the following project inputs:
    • Feasibility builds, documentation, and testing
    • Equipment selection, process development and documentation
    • Device Verification samples and testing
    • Operator training
    • Process Failure Mode Effects Analysis
    • Clinical builds
    • Process Validation
  • Involvement in the full design, development, and validation requirements of projects, including:
    • Product design and specification creation, including mechanical and electrical components, assemblies, and packaging
    • Materials sourcing and device prototyping
    • Design verification and validation activities, including data for regulatory submission
    • Manufacturing transfer and support of existing product lines as applicable
  • Reliable, consistent and punctual attendance is an essential function of the job
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Required Qualifications

  • A Bachelors’ degree in an engineering discipline with 5 years of relevant experience.
  • Experience in an engineering/manufacturing environment with a mix of mechanical design, tool design and manufacturing process experience.
  • Willingness to travel, if required.
  • Must maintain high ethical standards.
  • Must demonstrate good organizational skills.
  • Ability to train new engineering employees on project engineering activities and Cirtec policies and procedures.
  • Must be able to read, write and speak fluent English.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications, illustrations, and written documents.
  • Strong analytical skills, must be able to obtain and evaluate secondary research information.
  • Ability to learn and apply new technology.
  • Moderate knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics.

Working Environment

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO Statement

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Engineer I, Industrial

Summary:

The Operational Excellence program seeks to minimize waste and variation through Lean and Six Sigma approaches leading to improved production processes and systems that operate at high efficiency levels. The Industrial Engineer (IE) is responsible for identifying and leading execution of a wide range of Continuous Improvement projects.  The IE leads, facilitates, executes, and manages team training initiatives and projects.  The IE will utilize knowledge of COGs, gross margin, facility design, material handling equipment, labor management, staff planning and project management to identify, quantify, prioritize and recommend improvement projects that align with the Operational Excellence team charter and organizational goals and objectives.

Responsibilities:

  • Participates in identification and planning of department goals implementation of initiatives intended to improve quality, cost and delivery
  • Serves as an engaging and collaborative teacher/trainer providing internal standardized lean training and consulting support for Lean & Six Sigma tools, data mining and presentation with heavy emphasis on MS Excel
  • Supports the philosophy of waste reduction through implementation of Lean and Six Sigma approaches within the organization
  • Utilizes tools and methodologies including, but not limited to time studies, line balancing, setup time reductions, line layout creation, flow improvement, 5S, standard work, visual factory improvements and accountability systems
  • Collaborates with cross-functional teams
  • Evaluates, designs, and implements new production line and facility layouts
  • Leads and/or facilitates A3 projects and teams
  • Collaborates with others on Key Process Indicator development and implementation
  • Seeks out continuous improvement opportunities, weighs their value based on benefit, investment, and risk, and prioritizes work accordingly
  • Participates in project work to help customers and operators achieve sustainable results
  • Complies with company, quality and safety standards, policies, and procedures
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BS degree required. Industrial Engineering highly preferred.  Advanced degree a plus
  • 2-5 years manufacturing experience, preferably in medical device and/or machining
  • Strong MS Excel knowledge
  • Six Sigma or Lean Certification (ASQ or IASSC) is a plus
  • Strong analytical, problem solving and project management skills
  • Must be a learner; adaptable to accept new changes in the field of lean manufacturing and desire to remain knowledgeable regarding the latest developments in field
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Ability to influence and engage others to accomplish projects
  • Must be able to read, write and speak fluent English
  • Must be a clear communicator of ideas in both written and oral forms to all levels of the organization
  • Strong organizational abilities; can multitask and prioritize to meet deadlines in timely manner
  • Ability to travel to other sites (approximately 5-10%)

WORKING ENVIRONMENT

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Technician II, Machine Maintenance

Summary:

This position is primarily responsible for all preventative and corrective maintenance on equipment located in the fab and plating areas.  Maximum emphasis is placed on positive response to the concerns and needs of the company and its environmental health and safety. This is a hands-on position that the equipment maintenance technician works independently and is capable of being successful in a matrix organization.

Responsibilities:

  • Maintain preventative operation of all production equipment.
  • Perform preventative maintenance as instructed by the Computer Machine Maintenance System (CMMS)
  • Complete work orders in the specified time, directed by the CMMS
  • Perform projects and other duties in a similar nature and complexity, as assigned by Manager
  • Keep work area clean and presentable while performing assigned tasks
  • Work in a safe manner
  • Safely use chemicals while performing assigned tasks
  • Lock/Out Tag Out of equipment when necessary, or instructed by Manager
  • Work independently when performing assigned tasks
  • Accountable for work performed
  • Perform Coolant tank Cleaning
  • Comply with company, quality and safety standards, policies, and procedures
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum 3-5 years’ experience in performing preventative and corrective maintenance on semiconductor related equipment.  Similar equipment experience will be considered.
  • Able to troubleshoot electronic circuits to a component level.
  • Experience with semiconductor processes and cleanroom controls, plasmas systems.
  • Experience with vacuum metal deposition systems.
  • Must have good computer, written and oral skills.
  • Must be able to read, write and speak fluent English.
  • Manual dexterity and visual acuity are required to perform responsibilities.
  • Must be able to lift 60 lbs.
  • Must be willing to work some weekends, alternating coverage with other maintenance techs.

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Senior Software Engineer

About the Company

More than just another design shop or contract manufacturer, Cirtec offers a uniquely comprehensive range of vertically integrated capabilities. Cirtec specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization.

Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers’ devices to market.  If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you!

You are part of: 

The engineering team consisting of other engineers with diverse backgrounds and expertise.  The Engineering team works in close collaboration with Operations, R&D, and Purchasing. You will be involved in the design, development, documentation and validation of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Job Summary

The Engineer, Software Development is primarily responsible for developing iOS software / testing applications for use in interfacing medical device hardware. This position will develop code to verify and validate the operation of active and passive implantable/external medical devices, and mobile applications. This individual will work with a multi-disciplinary engineering team including software, firmware, electrical, process, and mechanical hardware engineers. This team player will have experience with multi-tasking in a high energy fast paced environment. The person needs to have strong self-starting qualities to independently manage their participation in multiple projects to ensure timely and successful completion. Must be enthusiastic, positive, even tempered and have strong skills in areas of dependability, interpersonal relationships, and communication.

Responsibilities

  • Utilize the following IDE’s (Integrated Development Environment) XCode, Visual Studio 2019.
  • Create interfaces to Medical Implant Communication System (MICS) base stations and implants.
  • Create and review software requirements and software architecture documentation.
  • Develop software test plans and test protocols.
  • Author software unit test, integration / UI test, regression test code.
  • Participate in product development meetings and software/hardware design and risk analysis reviews.
  • Working knowledge of testing active and passive implantable/external medical devices; mobile applications and embedded medical devices.
  • Experience in creating and executing testcases and scripts to verify software and hardware requirements.
  • Ensure that medical device components are compliant with applicable international standards and requirements.
  • Maintain software/hardware design history file and participate in periodic phase reviews.
  • Report defects to the stakeholders and create test logs.
  • Provide inputs to the team to improve the medical device design and test outcomes.
  • Consistent and punctual attendance is an essential function of the job.
  • Use requirements management tools.
  • Use issue tracking tools.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications

  • 3-5 years of experience with XCode, Visual Studio, or Android Studio IDE development.
  • Working knowledge in electronics; analog, power and digital, oscilloscopes, and general electronic test equipment.
  • Good communication and interpersonal skills.
  • Experience in creating and executing test cases and scripts to verify software and hardware requirements.
  • Excellent oral, written, and presentation communication skills.
  • Bachelor’s Degree preferable in Electrical/Electronic/Biomedical/Computer Engineering OR extensive professional experience in medical device testing.
  • Proficiency of a software development language (C++, C#, Swift, Java).
  • Proficiency of a software development IDE (XCode, Android Studio, Visual Studio).
  • Proficiency of software testing suite (Google Test).

Preferred Qualifications:

  • 3-5 years’ experience in testing active implantable devices, hand-held devices and test equipment used for medical devices.
  • Familiarity with medical development standards such as IEC 60601-1, 62304, 60601-1-2, ISO 14708-1, 14708-3.
  • SysML, UML and MBSE.
  • Knowledge of Quality Control principles and methodology.
  • Two or more Software programming language proficiency (C#, Swift).
  • Two or more Software IDE proficiency (Visual Studio, XCode).
  • Agile Scrum methodology.

What We Offer

  • A fast-paced work environment
  • Clean, and well-lit production areas
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives, and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a company match

Working Environment

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO Statement

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Document Control Specialist

Summary:

The Document Control Specialist implements and maintains the Engineering Change Notice System. These changes will include product improvements, repairs, and new product development. Coordinates the interaction between engineering, manufacturing, field operations, and marketing to ensure appropriate changes are documented. Provides documentation such as good manufacturing practices (GMP) and good laboratory practices (GLP) procedure manuals and change authorization in accordance with company policies and government regulations.

Responsibilities:

  • Responsible for issuing part numbers and ECN’s and processing documents into the QMS software (i.e. Master Control, Syteline, etc.)
  • Responsible for communicating with customer for obtaining ECN approval.
  • Responsible for compiling and maintaining control records such as release drawings, project documents, quality system documents and manufacturing documents.
  • Responsible for making electronic changes to documents, release documents, and notifies affected departments.
  • Responsible for maintaining related Document Control files.
  • Responsible for ensuring documents are filed correctly and maintained per established procedures.
  • Perform database searches, minor data analysis, and reporting to assist Quality Assurance team.
  • Maintain logs and update CAPA, NCMR, Complaint and other Quality Systems files.
  • Prepare reports and memorandums.
  • Ensure Proper upkeep of quality records and documents.
  • Coordinates Training program, which includes facilitating the training and input results into the training QMS system.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • 2-3 years of Document Control experience in the Medical Device Industry required
  • Prior experience with PLM software system, such as Master Control is preferred
  • Strong knowledge in implementing, processing, and maintaining Cirtec and Customers documentation in ERP and PLM Software System
  • Extremely detail-oriented work habits
  • Flexible and motivated attitude
  • Must be able to read, write and speak fluent English
  • Proficient with MS Word, Excel
  • Knowledge of document control procedures with data storage, maintenance, revision and archival background
  • Familiarity with FDA Quality System Regulation (QSR) and ISO 13485

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Production Supervisor - 2nd Shift

Summary:

This position is primarily responsible to direct the development and implementation of activities in production area(s) to meet production goals, quality, and cost objectives. Plan, organize and schedule production activities to meet customer demands. Provide direction, leadership, and motivation to production personnel, including training and assistance with adhering to the quality system.

Responsibilities:

  • Provide leadership and direction across the associated shift ensuring proper levels of production and quality are met.
  • Responsible for ensuring conformance to all company policies, procedures, and work instructions.
  • Plan, organize, and schedule production activities (including personnel and equipment) to meet schedules for both standard production and development projects.
  • Coordinate hiring and training of new employees along with recording the status of the training.
  • Coordinate job rotations and cross training.
  • Prepare and submit performance reports along with determining what increases employees will receive based on performance.
  • Regularly communicate team performance to employees and management.
  • Preemptively coordinate material and system requirements to ensure minimum amount of downtime and recommend measures to improve production methods, yields, and the quality of product.
  • Maintain production goals and deadlines. Preemptively coordinate material and system requirements to ensure minimum amount of downtime and recommend measures to improve production methods, yields, and the quality of product.
  • Manage production personnel, including planning personnel needs, participating in the hiring process, and managing performance.
  • Conduct daily team meetings for proper communication and development of production team.
  • Develop in depth knowledge of production processes and associated equipment, including laser workstations and CNC motion control programs.  Troubleshoot manufacturing issues as part of maintaining production schedule and developing self-reliance among production technicians.
  • Contribute to development, maintenance, and follow up of production metrics.
  • Plan, implement, and maintain the production environment with focus on safety, cleanliness, and organization.
  • Participate on and lead teams that improve safety, quality, and reliability in the production area, as well as teams that support cost saving and team building initiatives (QDC).
  • Plan and implement technical skills training for production personnel, including generic and product specific skills. Act as trainer when necessary.
  • Understand the requirements of and ensure compliance with the preventative maintenance program.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Associates degree or equivalent experience in a related field.
  • Be able to read, write and speak fluent English.
  • Minimum 3+ year’s supervisory experience in a manufacturing environment, preferably in a medical device manufacturing environment and in leadership role.
  • Computer literate (MS Office Suite, Syteline).
  • Understanding and implementation of Lean Manufacturing and Six Sigma for process improvement and problem solving.
  • Strong knowledge of ERP/MRP business functions.
  • Able to prioritize and manage multiple responsibilities.
  • Must be able to read blueprints and interpret technical specifications and illustrations.
  • Experience in technical report writing and verbal communication skills.

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Technician

Summary:

The Quality Technician is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, and quality systems.

Responsibilities:

  • Complies with company, quality and safety standards, policies, and procedures
  • Under Quality Engineer (QE) oversight, assist with qualification and validation (IQ, OQ, PQ).
  • Compile and analyze statistical data to assess process capabilities and control processes
  • Develop inspection test methods and draft inspection procedures with QE oversight
  • Handle Calibration Management including new and current equipment that requires calibration, calibration supplier management and out of tolerance reporting as required
  • Handle Environmental Monitoring Management including collecting samples, testing, entering and trending results and out of tolerance reporting as required
  • Support the nonconforming material reporting process including verifying nonconformance descriptions, evaluating to determine root cause of the nonconformance and proposing final disposition of nonconforming product
  • Review and approve inspection and device history records as required
  • Support CAPA process by assisting in the investigation and implementation of corrective action
  • Identify areas of improvement and participate in continuous improvement projects
  • Perform Gemba walks and participate in 5S activities
  • Support QEs and other duties as assigned An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High School diploma.
  • 1-3 years of experience in manufacturing environment (preferred requirement – Medical Device industry)
  • Knowledge of medical device regulations (21CFR820, ISO 13485)
  • Technical training and/or experience in related field
  • Working knowledge of basic inspection processes and measurement practices
  • Must be able to read, write and speak fluid English
  • Ability to read and interpret assembly drawings and specifications
  • High proficiency in use of computer systems using standard business software: Outlook, Word, PowerPoint, Excel, MRP/ERP systems
  • Strong verbal and written communication skills
  • Ability to work with a wide variety of functional areas including but not limited to Program Management, R&D, Manufacturing and QA as required accomplishing results with minimal guidance
  • Excellent organization and time management skills with an ability to think proactively and prioritize work
  • Flexible and able to accommodate changing priorities and directions

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Engineer II, Quality

Summary:

This position is primarily responsible for monitoring and auditing the quality of all manufactured goods in a medical device industry. Will work to not only find defects, but also to find the cause of the defect and develop a solution. Interact with customers and suppliers in support of engineering projects.

Responsibilities:

  • Provide Quality Engineering support for engineering project development, or sustained manufacturing.
  • Provide Quality Project Management support as needed for product transfers from development to validation.
  • Validation System Owner responsible for the development and management of the validation master plan along with the validation determination.
  • Develop and maintain Validation Standard Operating Procedures.
  • Develop and maintain project Quality Plan for assigned projects.
  • Develop protocols, perform statistical analyses, and write reports for validations and formal process development, which requires quality-engineering involvement such as DOEs.
  • Support the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols to ensure compliance with the Quality System.
  • Provide Quality Engineering support for manufacturing.
  • CAPA (Corrective and Preventative Action) system owner responsible for the support of the corrective action system and procedures.
  • Interact with customers and suppliers to resolve CAPA and complaint investigations and in support of manufacturing.
  • Provide Quality Support for the disposition of material via NCR’s.
  • Provide Quality Project Management Support as needed for product transfers from validation to production.
  • Vendor approval and maintain and assess vendor performance data (i.e. SCAR/on time).
  • Review and document procedure changes for quality requirements and compliance with the quality system.
  • Develop quality systems and procedures as needed.
  • Audit support for third party audits, customer audits and internal audits.
  • Support the implementation of continuous improvement initiatives for production processes.
  • Develop and maintain production quality control plans.
  • Initiate and maintain SPC (Statistical Process Control) for production processes.
  • Provide initiative and support for FMECA (Failure Modes & Effects Criticality Analysis), and DOE (Design of Experiment as applicable.
  • Comply with all work rules including those pertaining to safety, health, quality and Cirtec policies.
  • Back up to Quality Systems Administrator.
  • Perform other duties as necessary.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Analyze and process Information, Promote Process Improvement, Developing Standards, Managing Processes, Manufacturing Methods and Procedures, Supports Innovation.
  • Bachelor’s degree required, preferably in an engineering discipline.
  • Minimum experience in medical/manufacturing environment: 2-5 years
  • Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
  • Must possess excellent verbal communication, organizational and management skills.
  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access.
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Operator Assembler

Summary:

This position is primarily responsible for assembling product, associated systems, and basic operating of laser used in the manufacturing of products sold to our customers.  This position is expected to work with and assist in the training of lower-level operators to effectively meet or exceed expectations for product quality and production rates. It is also expected that in this position there will continue to build their skills with Technicians along with taking tasks and direction from the Engineering departments. In this position you must be proficient in setting up and operating workstations perform visual and dimensional inspections needed to manufacture the products at Cirtec.

Responsibilities:

  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Has the responsibility of following established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from Team Lead/Supervisor.
  • Will be proficient in the task of loading components into product specific tools.
  • Primary function, processing, and product fabrication.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • Performs complex workstation set up and troubleshooting tasks.
  • Performs various dimensional inspection using specific gauges, dimensional inspection systems, verniers and micrometers.
  • Provides training on processes to team members
  • Has the standard skills of operating manufacturing workstations including most laser systems used in the manufacture of products sold to our customers.
  • Proficient in the operation of computerized motion controllers.
  • Knowledge of welding operations.
  • Ability to perform workstation set up requirements for any type of processing job using existing tooling and established parameters.
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions.
  • Provides direction within the manufacturing cell to associates assigned to assist them.
  • Assists Quality Control with inspection duties as required.
  • Possesses the ability to accurately follow operating manuals, maintenance instructions, Standard operating procedures & work instructions.
  • Operate effectively and maintain professionalism in an environment of deadlines and high workloads and adjust schedule or work hours to meet changes in priorities.
  • Performs additional duties as required under the direction of the Production Team Leader/Supervisor.
  • Responsible for recognizing quality issues and communicating issues to the Quality and/ or Production Supervision.
  • Acts as a resource during audits or customer visits for questions and answers or practical demonstrations.
  • When assisting upper-level Technician or Engineer accurately document development activities in a lab notebook.
  • Ability to provide input to Engineering and upper-level Technicians in regard to tool design and/or troubleshooting processes.
  • Assists in ensuring the accuracy of Process Control Documents, Parameter Sheets, Work Instructions, and Standard Operating Procedures.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or General Education Degree (GED) is required
  • 4-6 years’ experience in medical device industry or equivalent training preferred.
  • Be able to read, write and speak fluent English.
  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail
  • Understanding of ISO & FDA requirements a plus.
  • Experience with LEAN manufacturing a plus.
  • Ability to work in environment subject to fluctuations in heat, humidity, fumes, odors, dust, and noise.
  • Capable in providing detailed information to assist sustaining engineering in determining root cause in order to identify the appropriate corrective action.
  • Strong interpersonal skills to establish and maintain cooperative and effective working relationships.
  • Good written and verbal communication skills.
  • Meets all requirements of Operator/Assembler Il
  • Experience in setting up and operating workstations.
  • Moderate computer skills, including the MS Office suite.
  • Must be able to interpret technical drawings, blueprints, specifications & illustrations.
  • Must be able to read, write and speak fluent English
  • Strong analytical skills and must have the ability to obtain secondary research information from the Internet or alternate sources.
  • Ability to learn and apply new technology.
  • Technical report preparation
  • Capacity to provide information to engineers for determining root cause in order to identify the appropriate corrective actions.
  • Strong understanding of performing visual and dimensional inspections.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Chemical Operator II

Summary:

This position is primarily responsible to develop and maintain cleaning etching and passivation processes and procedures to ensure the highest quality of components.  Ability to recognize safety in the mixing and neutralizing of acids.

Responsibilities:

  • Process parts utilizing both chemical and manual cleaning methods.
  • May perform receiving, processing, wiping, scrubbing, masking, chemical processing, machine operating, etching, blasting, coating, drying, baking, and other processes, as needed.
  • Follows all SOPs, Lean manufacturing processes, company policies and practices.
  • Complete training on assigned processes.
  • Perform daily organization and upkeep of assigned process areas.
  • Handle hazardous chemicals correctly and safely. Follow all policies and directions for safe use of and proper disposal of hazardous chemicals.
  • Participation and adherence to safety programs.
  • Must have exceptional skills at organizing tasks, efficiently managing their time and the ability to report out achieved task goals.
  • Maintain a high degree of safety and environmental awareness through the practice of safe work habits.
  • Work with metal cleaning, metal etching and passivation solutions.
  • Safely work with strong acids.
  • Must be familiar with MSDS and neutralization of acid waste.  Hydrofluoric acid is used in this position.
  • Wear all safety equipment required.
  • Communicate well with co-workers and vendors.
  • Promote efficiency and quality within the department and company.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High School Diploma.
  • 2 years of experience in metal finishing and have worked with acids required.
  • 3 years of experience in medical manufacturing or assembly required.
  • Ability to handle repetitive work and provide fast turn-around on production related to masking, wiping, processing parts.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Laser Weld Technician

About the Company

More than just another design shop or contract manufacturer, Cirtec offers a uniquely comprehensive range of vertically integrated capabilities. Cirtec specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization.

Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers’ devices to market.  If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you!

You are part of: 

The engineering team consisting of other engineers with diverse backgrounds and expertise.  The Engineering team works in close collaboration with Operations, R&D, and Purchasing. You will be involved in the design, development, documentation and validation of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Job Summary

This Sr. Technician, Laser position is responsible for the safe and functional operation of Femto laser cutting equipment within the R&D organization.  Will be responsible for developing manual or CAD programs required to cut tube and flat components.  Will assist in the development of tooling and fixtures required.

Responsibilities

  • Provide process training to production operators
  • Perform characterizations, IQ’s, OQ’s, PQ’s, and validations
  • Provide Laser samples when appropriate to support sales effort
  • Provide assistance to Engineering to develop laser quotations and manufacturing procedures
  • Develop CNC programming using a camming software to efficiently meet print requirements
  • Assist Engineering in designing tooling for production
  • Interface with Quality to develop inspection procedures to verify acceptability of components
  • Maintain and promote laser and team safety
  • Evaluate and recommend alternative manufacturing methods
  • Maintain and encourage other to maintain a clean and orderly work area
  • Research and recommend capital equipment for the yearly budget
  • Ensure laser maintenance program is 100% up to date
  • Provides leadership to the team and interrelates well with all areas of the company
  • Effectively resolves all problems that arise or seek assistance in a timely manner
  • Assists the Team Manager in developing highly skilled individuals to be high quality efficient operators
  • Performs duties in a manner to promote good department morale with the team
  • Trains team members and new employee on machines and department procedures
  • Maintains schedules of machines to best meet customer requirements based on meeting daily production
  • Schedule as supplied by M2M and Production Control
  • Demonstrates responsibility for department efficiency, quality, pre-production planning, process control, corrective actions, cleanliness, and safety
  • Ensures that job BOM’s are accurate and tooling is ordered on timely manner
  • Reliable, consistent, and punctual attendance is an essential function of the job
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications

  • Degree/certificate in Laser Technology or related field helpful; electrical/mechanical or electronics, Automation Technology, Automated Machinery Systems, Robotics
  • Recent Femto laser cutting experience
  • Experience with high tolerance cutting, welding and drilling of metals
  • Set up of laser parameters
  • Experience or a desire to learn CAD/CAM software

Working Environment

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO Statement

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Manager

Summary:

The Quality Manager will be responsible for the leadership and management of Quality personnel and resources to ensure compliance to Cirtec Medical’s Quality Management System. The Quality Manager may be the designated Management Representative for the Quality Management System.  The Quality Manager will also be responsible for overseeing Quality engineering activities to support sustaining manufacturing operations, and product development programs.

Responsibilities:

  • Responsible for oversight and compliance of the Quality Management System.
  • Responsible for ensuring that the processes needed for the Quality System requirements are established and maintained in accordance with applicable regulations and standards.
  • Responsible for ensuring the promotion and awareness of applicable regulatory requirements and Quality Management System requirements throughout the site’s organization.
  • Responsible for leading Management Review meetings and reporting the performance and effectiveness of the Quality System, as well as any improvements needed, for periodic review and analysis.
  • Oversee Complaint Analysis and Corrective and Preventive Action Systems, and the tracking / reporting of metrics.
  • Manage Quality Control staff to provide incoming (receiving & inspection), in-process inspection, final inspection, and product release activities for all manufacturing programs.
  • Responsible for overseeing or delegating the creation of QMS related Quality Plans that are site-specific.
  • Depending on Cirtec site may manage Design and Development Quality staff.
  • Provide organizational leadership, coaching, mentoring and guidance to all Quality personnel as well as cross-functional teams.
  • Drive and support corporate Quality Management System initiatives.
  • In partnership with other Cirtec Medical Quality Leaders, ensure establishment and maintenance of site registrations (e.g., ISO 13485 and FDA).
  • Act as site champion for Quality Best Practices and cGMP within Cirtec Medical.
  • Ensure accountability for Design Controls and DHF management of internal and customer development programs and design transfers.
  • Provide Quality Engineering support for internal and customer development programs and sustaining manufacturing process/continuous improvement efforts.
  • Initiate and/or collaborate in the generation/update of process / product Risk Management documentation, e.g., FMEAs and Hazard Analysis, in collaboration with cross-functional engineering teams.
  • Develop and perform qualifications and validations for manufacturing processes in collaboration with cross-functional engineering teams per project requirements.
  • May author, review and/or approve documentation for process and design change activities as well as validation / verification oversight and/or test method execution in cooperation with cross-functional engineering teams per project requirements.
  • Represent Quality Engineering in program / project phase reviews throughout the product development and transfer to manufacturing phases and process improvement initiatives.
  • Support and oversee the Nonconformance Materials Review Board process.
  • Manage metrology and calibration activities.
  • Primary lead for external regulatory, certification, and customer audits.
  • Manage support for local and corporate Documental Control (PLM) and Material Resource Planning (MRP) systems implementations, integrations, and improvements.
  • Manage Quality Systems staff to provide Documentation Control and records retention functions, Incoming/Final Inspection, Complaint Analysis, Corrective Action System and Quality Control training to Customer Focused Business Units.
  • Complies with company, safety and quality standards, policies, and procedures.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor of Science or equivalent experience, preferably in an engineering discipline.
  • Minimum 7 years of experience in a regulated medical device environment, preferably as a Sr or Principal Quality Engineer or Quality Manager, with supervisory and decision-making responsibilities.
  • Quality and/or Regulatory certification(s) preferred (ASQ, Lead Auditor, etc.).
  • Knowledge and experience with external standards and regulations: ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier auditing & management, quality control (GD&T, MRB, etc.), CAPA and customer complaints.
  • Experience with Class II and Class III medical device development and manufacturing.
  • Demonstrable knowledge and experience with Manufacturing Process tools/methodologies including: Process Change Assessment, Risk Management (Hazard Analysis), Process FMEA, Statistical Analysis, Process Qualification, Gauge R&R, and Inspection/Test Method Validation.
  • Experience in effectively managing audits by customers and regulatory agencies.
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.
  • Strong verbal and written communication skills. Ability to present complex information to internal and external contacts.
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access.
  • Experience in coaching and developing direct reports, utilizing performance management tools and disciplines, while increasing employee engagement and retention.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Embedded Software Engineer

About the Company

More than just another design shop or contract manufacturer, Cirtec offers a uniquely comprehensive range of vertically integrated capabilities. Cirtec specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization.

Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers’ devices to market.  If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you!

You are part of: 

The engineering team consisting of other engineers with diverse backgrounds and expertise.  The Engineering team works in close collaboration with Operations, R&D, and Purchasing. You will be involved in the design, development, documentation and validation of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Job Summary

The Embedded Software Engineer will be responsible for software development for Class II and III medical devices. Based out of our headquarters in Brooklyn Park, MN, Cirtec Medical is a vertically integrated, full-service, outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development, and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably, and cost-effectively.

Responsibilities

  • Develop embedded software designs for various active implantable medical device applications.
  • Our embedded software typically runs in an environment that includes a microcontroller/processor of the ARM or MSP430 class, MICS-band and/or Bluetooth Low Energy communications, inductive recharging circuits, and fully custom ASICs.
  • We also develop code for a variety of external devices used by clinicians and patients to interact with the implanted device.
  • Develop software requirements and create software design control documents.
  • Perform software design risk management activities according to applicable standards in the medical device field.
  • Unit, integration, and system testing of developed embedded software including static and dynamic testing.
  • Participate in design reviews and in software process development activities.
  • Create and maintain project plans and Design History Files (DHF) for each project.
  • Develop embedded software life cycle plan and management for new products.
  • Reliable, consistent and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications

  • BS in Electrical Engineering, Computer Engineering, Software Engineering or in an equivalent engineering discipline.
  • 2+ years of experience in embedded systems software development preferably with active implantable medical devices.
  • Extensive experience programming in C, and C++ for embedded medical device applications.
  • Experience using hardware diagnostic instruments to troubleshoot embedded devices.
  • Excellent oral, written, and presentation communication skills.

Preferred Qualifications:

  • Engineering experience with active and passive implantable devices and peripherals for Class III medical devices.
  • Experience with Texas Instruments and Zarlink microcontrollers, DSP, SPI, I2C.
  • Experience with MICS-band and/or BLE communications.
  • Exposure to Model-based Systems Engineering (MBSE), SysML, UML.
  • Demonstrated experience working with Human Interface Devices (HIDs).
  • Familiar with IEC 60601 and IEC 62304 international standards.

What We Offer

  • A fast-paced work environment
  • Clean, and well-lit production areas
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives, and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a company match

Working Environment

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO Statement

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Mechanical Design Engineer

About the Company

More than just another design shop or contract manufacturer, Cirtec offers a uniquely comprehensive range of vertically integrated capabilities. Cirtec specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization.

Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers’ devices to market.  If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you!

You are part of: 

The engineering team consisting of other engineers with diverse backgrounds and expertise.  The Engineering team works in close collaboration with Operations, R&D, and Purchasing. You will be involved in the design, development, documentation and validation of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Job Summary

The Senior Mechanical Design Engineer is primarily responsible for defining, designing, and developing medical devices and related accessories.  Owns efforts in developing solutions to product design, and design for manufacturability, translating requirements from the customer into realized products. Able to multitask and run multiple projects while meeting customer commitments.  Lead the design efforts for small to medium scale programs, independently, acting as a technical lead and mentor to other engineers on these programs.

Responsibilities

  • Owns the design and development of medical devices through:
    • Transformation of internal and external inputs into outputs
    • Developing design requirements and specifications with mechanical and electrical components and assemblies
    • Creating test methods and corresponding test method validations
    • Leading dFMEA creation
    • Coordinating design verification activities
    • Generating 3D models and engineering drawings utilizing Solidworks
    • Performing tolerance analyses to ensure component interactions are understood
    • Understanding the functional performance of the products as they are developed
    • Communicating technical risks as they arise
  • Host design reviews with internal and external stakeholders
  • Manage workload to support various projects, in small to medium scale and complexity
  • Mentorship of other engineers in various functions
  • Maintain compliance to procedures and regulatory requirements
  • Good understanding of the product development process within the medical device industry
  • Provides regular status updates to management and or customer
  • Writes/updates work instructions, part specifications, verification protocols, and various technical documents
  • Reliable, consistent and punctual attendance is an essential function of the job
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications

  • Bachelor’s degree in an Engineering discipline or related field
  • Minimum of 3 years of experience
  • FDA, cGMP, GDP principles and practices, (ISO 9001, ISO 13485)
  • Proficiency with Solidworks required
  • Knowledge of dimensioning and tolerances, GD&T
  • Computer skills associated with Microsoft software
  • Must be able to read, write and speak fluent English
  • Excellent reading, writing, communication, and organizational skills
  • Maintains performance with changing priorities under supervision
  • Possess team collaboration skills
  • Strong mechanical aptitude

What We Offer

  • A fast-paced work environment
  • Clean, and well-lit production areas
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives, and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a company match

Working Environment

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO Statement

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Assembly 2nd Shift Team Lead

Summary:

This position is primarily responsible to motivate the team to meet production, quality goals, and objectives.  Provide complete, timely, and informative communication to all shifts.  Ensure that Production Control schedule is followed and contribute to all teams achieving monthly production schedules and quality goals.

Responsibilities:

  • Assesses risks and seeks appropriate assistance from Production Manager/Supervisor.
  • Ensures safety guidelines are understood and followed at all times.
  • Resolves production problems and documents issues for discussion in meetings with Management, Engineering and Quality.
  • Recommends operational changes to Production Manager/Supervisor.
  • Gives and receives employee feedback.
  • Identifies training and cross-training needs and ensures completion of training records for work cell.
  • Facilitates team participation.
  • Ensures material transactions are documented and communicated to Production & Inventory Control as needed to support accurate inventory counts.
  • Shop cleanliness and tidiness: Work cell is responsible for cleaning the area on a daily basis in accordance with established procedures.
  • Will have authority to shut down production for out-of-control situations, contact necessary personnel to solve problems, request additional resources and move resources to other areas for temporary assignments.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or GED.
  • Minimum 5 years’ experience in a progressive manufacturing environment.
  • Prior experience in a Contract Manufacturing Operation (CMO) is preferred.
  • Relevant experience in leading team performance and regulatory compliance.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Operator Assembler

Summary:

This position is primarily responsible for assembling product, associated systems, and basic operating of laser used in the manufacturing of products sold to our customers.  This position is expected to work with and assist in the training of lower-level operators to effectively meet or exceed expectations for product quality and production rates. It is also expected that in this position there will continue to build their skills with Technicians along with taking tasks and direction from the Engineering departments. In this position you must be proficient in setting up and operating workstations perform visual and dimensional inspections needed to manufacture the products at Cirtec.

Responsibilities:

  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Has the responsibility of following established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from Team Lead/Supervisor.
  • Will be proficient in the task of loading components into product specific tools.
  • Primary function, processing, and product fabrication.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • Performs complex workstation set up and troubleshooting tasks.
  • Performs various dimensional inspection using specific gauges, dimensional inspection systems, verniers and micrometers.
  • Provides training on processes to team members
  • Has the standard skills of operating manufacturing workstations including most laser systems used in the manufacture of products sold to our customers.
  • Proficient in the operation of computerized motion controllers.
  • Knowledge of welding operations.
  • Ability to perform workstation set up requirements for any type of processing job using existing tooling and established parameters.
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions.
  • Provides direction within the manufacturing cell to associates assigned to assist them.
  • Assists Quality Control with inspection duties as required.
  • Possesses the ability to accurately follow operating manuals, maintenance instructions, Standard operating procedures & work instructions.
  • Operate effectively and maintain professionalism in an environment of deadlines and high workloads and adjust schedule or work hours to meet changes in priorities.
  • Performs additional duties as required under the direction of the Production Team Leader/Supervisor.
  • Responsible for recognizing quality issues and communicating issues to the Quality and/ or Production Supervision.
  • Acts as a resource during audits or customer visits for questions and answers or practical demonstrations.
  • When assisting upper-level Technician or Engineer accurately document development activities in a lab notebook.
  • Ability to provide input to Engineering and upper-level Technicians in regard to tool design and/or troubleshooting processes.
  • Assists in ensuring the accuracy of Process Control Documents, Parameter Sheets, Work Instructions, and Standard Operating Procedures.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or General Education Degree (GED) is required
  • 4-6 years’ experience in medical device industry or equivalent training preferred.
  • Be able to read, write and speak fluent English.
  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail
  • Understanding of ISO & FDA requirements a plus.
  • Experience with LEAN manufacturing a plus.
  • Ability to work in environment subject to fluctuations in heat, humidity, fumes, odors, dust, and noise.
  • Capable in providing detailed information to assist sustaining engineering in determining root cause in order to identify the appropriate corrective action.
  • Strong interpersonal skills to establish and maintain cooperative and effective working relationships.
  • Good written and verbal communication skills.
  • Meets all requirements of Operator/Assembler Il
  • Experience in setting up and operating workstations.
  • Moderate computer skills, including the MS Office suite.
  • Must be able to interpret technical drawings, blueprints, specifications & illustrations.
  • Must be able to read, write and speak fluent English
  • Strong analytical skills and must have the ability to obtain secondary research information from the Internet or alternate sources.
  • Ability to learn and apply new technology.
  • Technical report preparation
  • Capacity to provide information to engineers for determining root cause in order to identify the appropriate corrective actions.
  • Strong understanding of performing visual and dimensional inspections.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Operator Assembler II

Summary:

This position is primarily responsible for operating workstations and associated systems used in the manufacturing of products sold to our customers. This position is expected to work with lower-level Operators along with higher level Technicians to effectively meet or exceed expectations for product quality and production rates. In this position they must have a basic knowledge of how to set up and operate workstations, perform visual and dimensional inspections needed to manufacture the products at Cirtec.

Responsibilities:

  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Has the responsibility of following established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from upper-level operators assigned to that cell.
  • Will be proficient in the task of loading components into product specific tools.
  • Primary function, processing, and product fabrication.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • Performs basic workstation set up and troubleshooting tasks.
  • Performs various dimensional inspection using specific gauges, dimensional inspection systems, verniers and micrometers.
  • May perform weld operations.
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions.
  • Provides direction within the manufacturing cell to associates assigned to assist them.
  • Assists Quality Control with inspection duties as required.
  • Recognizes quality issues and communicates these issues to Quality and/or Supervisor.
  • Must accurately document all work performed on inspection reports and customer travelers.
  • Assists in packaging of finished goods as needed.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or General Education Degree (GED) is required
  • 2-4 years’ experience in medical device industry, preferred but not required.
  • Be able to read, write and speak fluent English.
  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail
  • Meets all requirements of Operator/Assembler I
  • Knowledge of how to set up and operate workstations.
  • Ability to provide information to engineers for determining root cause in order to identify the appropriate corrective actions.
  • Knowledge of performing visual and dimensional inspections.
  • Must be able to read, write and speak fluent English
  • Strong interpersonal skills to establish and maintain cooperative and effective working relationships.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Operator Assembler I - Laser

Summary:

This position is primarily responsible for assembling a range of components into finished goods across one or more production lines ensuring standard documentation, quality, and production rates are met. Works under the direction of the Production Team Leader/Supervisor.

Responsibilities:

  • Complies with company, quality and safety standards, policies, and procedures.
  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Has the responsibility of following established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from upper-level operators assigned to that cell.
  • Will be proficient in the task of loading components into product specific tools.
  • Primary function of assisting production operators and technicians engaged in processing and product fabrication.
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • May perform weld operations.
  • Must accurately document all work performed on inspection reports and customer travelers.
  • Assists in packaging of finished goods as needed.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or General Education Degree (GED) is required.
  • One year experience in a manufacturing environment preferred but not required.
  • Must be able to read, write and speak fluent English.
  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail.
  • Knowledge of ISO & FDA requirements a plus.
  • Experience with LEAN manufacturing a plus.
  • Ability to work in environment subject to fluctuations in heat, humidity, fumes, odors, dust, and noise.
  • Ability to provide detailed information to assist sustaining engineering in determining root cause in order to identify the appropriate corrective action.
  • Good interpersonal skills to establish and maintain cooperative and effective working relationships.
  • Good written and verbal communication skills.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Operator Assembler II

Summary:

This position is primarily responsible for operating workstations and associated systems used in the manufacturing of products sold to our customers. This position is expected to work with lower-level Operators along with higher level Technicians to effectively meet or exceed expectations for product quality and production rates. In this position they must have a basic knowledge of how to set up and operate workstations, perform visual and dimensional inspections needed to manufacture the products at Cirtec.

Responsibilities:

  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Has the responsibility of following established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from upper-level operators assigned to that cell.
  • Will be proficient in the task of loading components into product specific tools.
  • Primary function, processing, and product fabrication.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • Performs basic workstation set up and troubleshooting tasks.
  • Performs various dimensional inspection using specific gauges, dimensional inspection systems, verniers and micrometers.
  • May perform weld operations.
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions.
  • Provides direction within the manufacturing cell to associates assigned to assist them.
  • Assists Quality Control with inspection duties as required.
  • Recognizes quality issues and communicates these issues to Quality and/or Supervisor.
  • Must accurately document all work performed on inspection reports and customer travelers.
  • Assists in packaging of finished goods as needed.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or General Education Degree (GED) is required
  • 2-4 years’ experience in medical device industry, preferred but not required.
  • Be able to read, write and speak fluent English.
  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail
  • Meets all requirements of Operator/Assembler I
  • Knowledge of how to set up and operate workstations.
  • Ability to provide information to engineers for determining root cause in order to identify the appropriate corrective actions.
  • Knowledge of performing visual and dimensional inspections.
  • Must be able to read, write and speak fluent English
  • Strong interpersonal skills to establish and maintain cooperative and effective working relationships.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Inspector II - First shift Monday-Friday 7:00 am - 3:30 pm

Summary:

This position is primarily responsible for performing receiving, first piece, in-process and final inspection or test on a wide variety of parts and document results. Indicate inspection status, maintain product traceability and non-conforming material control. Participate in internal audits, statistical process control and assist control of process documentation, records, and equipment calibration.

Responsibilities:

  • Inspect, measure and/or test incoming parts, production first piece, in-process and final product, record results and notify appropriate personnel.
  • Indicate inspection status of parts with assigned labels and stamps.
  • Maintain product identification and traceability.
  • Control non-conforming product in accordance with documented procedures and verify timely corrective and preventative action.
  • Protect product during handling and storage in the performance of work.
  • Monitor factory environmental conditions, record data and alert adverse conditions.
  • Assist with distribution and control of process documentation and quality records.
  • Assist with control of measuring and test equipment calibration.
  • Participate in internal quality audits to verify compliance with documented procedures and specifications, record results and verify audit corrective action.
  • Assist with statistical methods of verifying and controlling process capability.
  • Provide input when required to quality planning for specific projects and products.
  • Provide leadership to production personnel on quality issues.
  • Comply with and reinforce the requirements of the Cirtec Quality System Manual and Standard Operating Procedures, ISO 9002, FDA Quality System Regulations, and other customer standards.
  • Follow Occupational Safety and Health regulations, including laser safety practices.
  • Other agreed duties within the Quality Department consistent with training, qualification, and experience.
  • Provide Quality Support for the disposition of discrepant material.
  • Provide leadership to production personnel in relation to quality.
  • Provide Quality Control support to Manufacturing & Engineering.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English
  • High school diploma or GED
  • 3-5 years’ minimum experience in manufacturing, preferably medical devices, with increasing responsibility or a minimum of 5 years’ experience in a manufacturing environment.
  • Certificate/s of training related to this field of work (medical or quality assurance)
  • 3 years’ experience as a Quality Control Inspector
  • Proven experience in inspection and documenting results
  • Able to demonstrate competence in interpreting technical drawings & specifications
  • Proficient in the use of microscopes, measuring and test equipment
  • Able to check dimensions, squareness, hole locations, surface relationships, finish material defects and mechanical strength of product following appropriate training
  • Have experience in the use of PC’s and Microsoft Office software applications
  • Brooklyn Park Additional Qualifications:
    • Prefer experience and familiarity with operations such as cleanroom manufacturing, Swiss machining, milling, stamping, laser cutting, laser welding, coiling, crimping, swaging, adhesive bonding/backfill, liquid silicone & thermoplastic injection molding, annealing, and general mechanical assembly.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Inspector II

Summary:

This position is primarily responsible for performing receiving, first piece, in-process and final inspection or test on a wide variety of parts and document results. Indicate inspection status, maintain product traceability and non-conforming material control. Participate in internal audits, statistical process control and assist control of process documentation, records, and equipment calibration.

Responsibilities:

  • Inspect, measure and/or test incoming parts, production first piece, in-process and final product, record results and notify appropriate personnel.
  • Indicate inspection status of parts with assigned labels and stamps.
  • Maintain product identification and traceability.
  • Control non-conforming product in accordance with documented procedures and verify timely corrective and preventative action.
  • Protect product during handling and storage in the performance of work.
  • Monitor factory environmental conditions, record data and alert adverse conditions.
  • Assist with distribution and control of process documentation and quality records.
  • Assist with control of measuring and test equipment calibration.
  • Participate in internal quality audits to verify compliance with documented procedures and specifications, record results and verify audit corrective action.
  • Assist with statistical methods of verifying and controlling process capability.
  • Provide input when required to quality planning for specific projects and products.
  • Provide leadership to production personnel on quality issues.
  • Comply with and reinforce the requirements of the Cirtec Quality System Manual and Standard Operating Procedures, ISO 9002, FDA Quality System Regulations, and other customer standards.
  • Follow Occupational Safety and Health regulations, including laser safety practices.
  • Other agreed duties within the Quality Department consistent with training, qualification, and experience.
  • Provide Quality Support for the disposition of discrepant material.
  • Provide leadership to production personnel in relation to quality.
  • Provide Quality Control support to Manufacturing & Engineering.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English
  • High school diploma or GED
  • 3-5 years’ minimum experience in manufacturing, preferably medical devices, with increasing responsibility or a minimum of 5 years’ experience in a manufacturing environment.
  • Certificate/s of training related to this field of work (medical or quality assurance)
  • 3 years’ experience as a Quality Control Inspector
  • Proven experience in inspection and documenting results
  • Able to demonstrate competence in interpreting technical drawings & specifications
  • Proficient in the use of microscopes, measuring and test equipment
  • Able to check dimensions, squareness, hole locations, surface relationships, finish material defects and mechanical strength of product following appropriate training
  • Have experience in the use of PC’s and Microsoft Office software applications
  • Brooklyn Park Additional Qualifications:
    • Prefer experience and familiarity with operations such as cleanroom manufacturing, Swiss machining, milling, stamping, laser cutting, laser welding, coiling, crimping, swaging, adhesive bonding/backfill, liquid silicone & thermoplastic injection molding, annealing, and general mechanical assembly.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Engineering Intern

Responsibilities:

  • Prepare engineering change orders and coordinate the deployment of changes including training operation team members.
  • Develop and qualify various tools and equipment required for manufacturing processes.
  • Assist with 3D printing design and able to understand CAD models.
  • Utilizing tools associated with risk management (e.g. PFMEA) to identify potential risks and the associated corrective actions.
  • Supporting required equipment qualification and process validations (IQ, OQ and PQ).
  • Troubleshoot manufacturing processes when defects occur. Determine root cause and implement effective containment and countermeasures.
  • Disposition non-conforming products and develop re-work procedures.
  • Participate Kaizen events and drive continuous improvement efforts.
  • Provide new ideas for process improvements, design new fixtures and optimize automation process.
  • Support the Control of Nonconforming Material process.
  • Support the Corrective and Preventive Action (CAPA) process.
  • Identify areas of improvement and participate in continuous improvement projects.
  • Assist with qualification and validation (IQ, OQ, PQ).
  • Assist with Test Method Validation (TMV).
  • Perform Gemba walks and participate in 5S activities.
  • Support MEs, QEs and other duties as assigned.
  • Comply with company, quality and safety standards, policies, and procedures.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Enrollment in a degree program (ex., Manufacturing, Mechanical, Industrial Engineering, Chemical, Biomedical)
  • Must be able to read, write and speak fluid English
  • Ability to read and interpret assembly drawings and specifications
  • Proficiency in use of computer systems using standard business software: Outlook, Word, PowerPoint, Excel
  • Good verbal and written communication skills
  • Excellent organization and time management skills with an ability to think proactively and prioritize work
  • Flexible and able to accommodate changing priorities and directions

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None/PPE

WORKING ENVIRONMENT

Work is performed in an office and manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Manufacturing Engineer

Summary:

This position is primarily responsible for developing and implementing robust cost-effective manufacturing processes and methods in accordance with product specifications and Class III medical device quality standards.  This position recommends and implements improvements to sustained production processes, methods and controls; as well as coordinates the launch of new products into pilot production.

Responsibilities:

  • Improves manufacturing processes, methods and controls for cost reduction, quality improvements and efficiency for both sustained and new products.
  • Prepares engineering change orders and coordinates the deployment of changes including training operation team members.
  • Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance for both sustained and new products.
  • Coordinates the manufacturing launch of new products including establishing yield targets, run rates, training needs and evaluating results.
  • Develop and qualify various tools and equipment required for manufacturing processes.
  • Performs product and process analysis for cost reduction, quality improvement and improved efficiency.
  • Utilizing tools associated with risk management (e.g. PFMEA) to identify potential risks and the associated corrective actions.
  • Supporting required equipment qualification and process validations (IQ, OQ and PQ).
  • Troubleshoot manufacturing processes when defects occur.  Determine root cause and implement effective containment and countermeasures.
  • Disposition non-conforming products and develop re-work procedures.
  • Communicate with customers regarding process improvements and production changes.
  • Represent manufacturing on cross functional teams.
  • Lead Kaizen events and drive continuous improvement efforts.
  • Provide new ideas for process improvements, design new fixtures and optimize automation process
  • Take charge of the transfer of new products from R&D to commercial manufacturing
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor’s degree in Engineering or related field.
  • Knowledge of manufacturing and assembly processes.
  • Excellent verbal and written communication skills.
  • Fluency in English.
  • Minimum 2-5 years of experience with Class II or III Medical devices, FDA standards, ISO 13485 and GMP principles.
  • Leadership skills, including ability to organize, clarify and influence others.
  • Must be able to read blueprints and interpret technical specifications and illustrations.
  • Association with supporting documents including, ECN’s, process deviation, non-conformances, stop shipment notifications and all associated quality related documents.
  • Strong computer skills associated with MS Office suite, Minitab and SolidWorks a plus.
  • Experience associated with continuous improvement activities, including participations and/or facilitating Kaizen events using lean manufacturing principles.
  • The ability to understand a range of engineering functions and procedures.
  • Interpersonal, presentation and communication skills.
  • The capacity to work well under pressure and take on new challenges.
  • Organizational and time management skills.
  • Project management skills and the ability to work to tight deadlines.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None/PPE

WORKING ENVIRONMENT

Work is performed in an office and manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Engineer II, Process Development

About the Company

More than just another design shop or contract manufacturer, Cirtec offers a uniquely comprehensive range of vertically integrated capabilities. Cirtec specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization.

Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers’ devices to market.  If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you!

Why should you join Cirtec?

Working at Cirtec is more than a job. Our employees have the satisfaction of knowing that the work they do is helping patients live better, longer lives, and they take pride in the work they perform for one of the industry’s top medical device contract manufacturers. Here at Cirtec, every employee is highly valued and crucial to our success. We place a high value on performance excellence, career development, safety, rewards and communication. Cirtec has exciting opportunities where you can make a difference.

Job Summary

The Engineer II, Process Development position is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities

  • Attends and arranges project meetings to discuss current and future design and development initiatives.
  • May serve as a primary contact with clients on projects of low to moderate complexity.
  • Assist with preparation of proposals and quotations for clients; interface as needed to resolve Engineer Process Development questions in a timely manner.
  • Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Have input to project manager for tracking and communicating project status, plans, issues, timelines, action items, and budgets.
  • Responsible for the following project inputs:
    • Feasibility builds, documentation, and testing
    • Equipment selection
    • Process development and documentation
    • Device Verification samples and testing
    • Operator training
    • Process Failure Mode Effects Analysis
    • Clinical builds
    • Process Validation
  • Involvement in the full design, development, and validation requirements of projects, including:
    • Product design and specification creation, including mechanical and electrical components, assemblies, and packaging
    • Materials sourcing and device prototyping
    • Design verification and validation activities, including data for regulatory submission
    • Manufacturing transfer and support of existing product lines as applicable
  • Reliable, consistent and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications

  • A Bachelor’s degree in an engineering discipline
  • Willingness to travel, if required
  • Must maintain high ethical standards
  • Must demonstrate good organizational skills
  • Must be able to read, write and speak fluent English
  • Experience in an engineering/manufacturing environment with mechanical, tool design, and manufacturing processes preferred
  • Strong computer skills, including the MS Office suite and MS Project
  • Must be able to fully interpret technical drawings, blueprints, specifications & illustrations
  • Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information
  • Ability to learn and apply new technology
  • Technical report preparation and formal presentation skills

What We Offer

  • A fast-paced work environment
  • Clean, and well-lit production areas
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a company match

Working Environment

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO Statement

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Facilities Technician I Intern

Summary

The Cirtec Medical Facilities Team is bringing a brand-new facility online in Brooklyn Park and we are looking for another team member to help us during this exciting time!  We are finalizing plans and installations of utilities for equipment and processing functions. We will be performing facility system start-ups, training and establishing operational requirements and processes. We are ordering, relocating, and installing equipment throughout the facility.  Multiple department functions and processes are being supported as we grow! Come join our team if you are looking for a new, exciting and challenging opportunity!

Responsibilities

  • Safety First!  Maintain a safe and clean working environment.
  • Assist with assembly, installation, removal, testing, calibration, and maintenance of facility equipment and systems.
  • Document work performed, actions, irregularities, and continuing needs.
  • Assist with developing, documenting, deploying, and sustaining the predictive and preventive facilities maintenance program.
  • Assist with maintaining facilities and equipment parts and supplies inventories.
  • Communicate and respond in a timely manner to internal customers, contractors, suppliers, and vendors.
  • Ability to promote the company’s goals of customer service and quality through employee engagement and continuous improvement.
  • An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications

To perform this job successfully, an individual must be able to satisfactorily perform each essential duty and other duties as assigned.

  • Experience:  Associate degree (or in process of obtaining) in a technical field i.e., Industrial Maintenance Technician, HVAC Systems, Carpentry, Plumbing, Electrical Systems.  Alternatively, two or more years of related mechanical maintenance experience and/or maintenance of facility systems equipment.
  • Professionalism: Perform as a professional, effective, and positive member of the department and organization.
  • Communication:  Good verbal and written communication skills; ability to interact effectively with all team members, internal customers, contractors, suppliers, and vendors.
  • Schedule:  Flexibility to alter or adjust work schedules or locations is required in order to meet the demands of the business.
  • Emergency Schedule: The ability to respond to on-call emergencies will be required.
  • Skills: Ability to utilize foundational facility maintenance, industrial repair, and/or trade skills and equipment.  Ability to quickly learn new skills and tool usage.
  • Time Management: Ability to complete work to expectations in a timely manner.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Process Development Engineer I

About the Company

More than just another design shop or contract manufacturer, Cirtec offers a uniquely comprehensive range of vertically integrated capabilities. Cirtec specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization.

Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers’ devices to market.  If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you!

Why should you join Cirtec?

Working at Cirtec is more than a job. Our employees have the satisfaction of knowing that the work they do is helping patients live better, longer lives, and they take pride in the work they perform for one of the industry’s top medical device contract manufacturers. Here at Cirtec, every employee is highly valued and crucial to our success. We place a high value on performance excellence, career development, safety, rewards and communication. Cirtec has exciting opportunities where you can make a difference.

Job Summary

The Engineer I, Process Development is position is primarily responsible for a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities

  • Attends and arranges project meetings to discuss current and future design and development initiatives.
  • Tracks and communicates issues, status on assigned action items that would affect timelines and budget.
  • Can have responsibility for any of the following project inputs:
    • Feasibility builds, documentation, and testing
    • Equipment selection
    • Process development and documentation
    • Device Verification samples and testing
    • Operator training
    • Process Failure Mode Effects Analysis
    • Clinical builds
    • Process Validation
  • May have involvement in the design, development, and validation requirements of projects, including:
    • Product design and specification creation, including mechanical and electrical components, assemblies, and packaging.
    • Materials sourcing and device prototyping.
    • Design verification and validation activities, including data for regulatory submission.
    • Manufacturing transfer and support of existing product lines as applicable.
  • Reliable, consistent and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Required Qualifications

  • A Bachelor’s degree in an engineering discipline and minimum 2 years appropriate work experience;
  • Experience in an engineering/manufacturing environment with mechanical, tool design, and manufacturing processes preferred.
  • Must maintain high ethical standards.
  • Must demonstrate good organizational skills.
  • Must be able to read, write and speak fluent English.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications & illustrations.
  • Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information.
  • Ability to learn and apply new technology.
  • Technical report preparation and good small group presentation skills.
  • Willingness to travel, if required

What We Offer

  • A fast-paced work environment
  • Clean, and well-lit production areas
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a company match

Working Environment

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO Statement

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Operator Assembler II - Laser

Summary:

This position is primarily responsible for operating workstations and associated systems used in the manufacturing of products sold to our customers. This position is expected to work with lower level Operators along with higher level Technicians to effectively meet or exceed expectations for product quality and production rates. In this position they must have a basic knowledge of how to set up and operate workstations, perform visual and dimensional inspections needed to manufacture the products at Cirtec.

Responsibilities:

  • Complies with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Follows established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from upper-level operators assigned to that cell.
  • Proficient in loading components into product specific tools.
  • Primary function, processing, and product fabrication.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • Performs basic workstation set up and troubleshooting tasks.
  • Performs various dimensional inspection using specific gauges, dimensional inspection systems, verniers and micrometers.
  • May perform weld operations.
  • Operates a variety of wafer fab equipment in a production environment.
  • Manually manipulates fragile wafers on a regular basis.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions.
  • Provides direction within the manufacturing cell to associates assigned to assist them.
  • Assists Quality Control with inspection duties as required.
  • Recognizes quality issues and communicates these issues to Quality and/or Supervisor.
  • Must accurately document all work performed on inspection reports and customer travelers.
  • Assists in packaging of finished goods as needed.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or General Education Degree (GED) is required
  • 3-5 years’ experience in medical device industry, preferred but not required.
  • Be able to read, write and speak fluent English.
  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail
  • Meets all requirements of Operator/Assembler I
  • Knowledge of how to set up and operate workstations.
  • Ability to provide information to engineers for determining root cause in order to identify the appropriate corrective actions.
  • Knowledge of performing visual and dimensional inspections.
  • Strong interpersonal skills to establish and maintain cooperative and effective working relationships.

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Coil Winding Operator

Summary:

This position is primarily responsible for maintaining simple set-ups on Coil Winding machinery and have a good working knowledge of the machines.

Responsibilities:

  • Maintain an efficiency level of at least 100%
  • Accurately completes all department paperwork including in-process, first piece and count sheets
  • Good working knowledge of blueprints
  • Ability to change materials used to produce coils
  • Be familiar with functions of the machine including tooling and programming
  • Demonstrates concern for equipment by proper use of all equipment and maintaining a clean work area
  • Demonstrate an ability to use inspection equipment as required
  • Ability to solve problems of quality and efficiency working within the team
  • Part specific procedure and machine training by the team leader is required prior to any level 1 employee operating a machine or performing an operation
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • 1 year of microscope experience
  • Ability to communicate effectively
  • Able to read blueprints, instructions, schematics

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Technician II, Maintenance

Summary:

This position is primarily responsible for all preventative and corrective maintenance on equipment located in the fab and plating areas. Maximum emphasis is placed on positive response to the concerns and needs of the company and its environmental health and safety. This is a hands-on position that the equipment maintenance technician works independently and is capable of being successful in a matrix organization.

Responsibilities:

  • Responsible for preventative and corrective maintenance on all fab / plating area tool sets, including component disassembly / assembly / repair.
  • Responsible for identifying needed parts for repairs / preventative maintenance.
  • Perform preventative maintenance as instructed by the Computer Machine Maintenance System (CMMS).
  • Complete work orders in the specified time, directed by the CMMS.
  • Keep work area clean and presentable while performing assigned tasks.
  • Lock/Out Tag Out of equipment when necessary or instructed by Manager.
  • Performing coolant tank cleaning.
  • Properly hand and store chemicals and hazardous waste.
  • Maintain written logs of maintenance and repairs in our online system.
  • Ensure that facility maintenance requirements are consistently met.
  • Promptly respond to facilities related issues and ensure effective resolution.
  • Keep apprised of current regulations to effectively address and ensure compliance with ADA (Americans with Disabilities Act), OSHA (Occupational Safety & Health Administration), fire code requirements, and Material Management for Hazardous Material.
  • Conduct environmental monitoring including particle counts, cleanroom HEPA measurements etc.
  • Direct and coach junior technicians.
  • Triage and submit work order requests.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum 4 – 6 years’ experience in performing preventative and corrective maintenance on semiconductor related equipment. Similar equipment experience will be considered.
  • Able to troubleshoot electronic circuits to a component level.
  • Proficient with semiconductor processes and cleanroom controls
  • Familiar with vacuum systems.
  • Must have good computer, written and oral skills.
  • Manual dexterity and visual acuity are required to perform responsibilities.
  • Must be able to lift 60 lbs.
  • Must be willing to work some weekends, alternating coverage with other maintenance techs.
  • Must be legally authorized to work in the United States.
  • Must be able to work well as a team.
  • Must be willing to work overtime as required.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Electrical Engineer II

Summary:

The Electrical Engineer II position is primarily responsible the development of electro-mechanical designs for the creation of medical device products.

Responsibilities:

  • Performs design and analysis to achieve product performance, cost, reliability, manufacturability requirements.
  • Performs circuit design including analog input signal conditioning, embedded control, motor control, telemetry, and inductive power coupling.
  • Designs battery-powered Class III implantable medical devices.
  • Designs power supplies, battery systems, power management and charging circuits.
  • Designs and/or leads design of printed circuit assemblies and electromechanical assemblies.
  • Trouble shoots designs and maintains engineering notebook.
  • Works with interdisciplinary teams of mechanical and process engineers to integrate electronic designs.
  • Designs engineering development processes for schematic and layout capture.
  • Specifies and/or designs embedded software and firmware for test and verification purposes.
  • Develops electronic and electromechanical system requirements (specifications) and development plans.
  • Interfaces with and manages suppliers to fabricate prototype and final design components.
  • Participates in architecture design, subsystem requirements partitioning, requirements management and configuration management during product development.
  • Builds, tests, debugs, and maintains configuration of prototype assemblies.
  • Develops and executes formal design verification tests.
  • Develops documentation of specifications, designs, test plans and reports for inclusion in medical product Design History Files.
  • Creates and releases medical device manufacturing process instructions, bills of material, lot history travelers, and related documentation.
  • Participates in the development of quality inspection and manufacturing process instructions for electronic assemblies.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum BS/MS in an engineering discipline; with 5+ years’ experience in a product development role.
  • Familiarity and experience with electronic design automation tools: e.g.: schematic capture, analog and digital circuit simulation, tolerance and worst-case analysis, etc.
  • Experienced in at least two of the following areas:
  • Embedded control design
  • Embedded software and firmware design
  • Power supply and battery management circuits
  • Design of Lithium Ion Battery Packs
  • Motor control: stepper, BLDC controls and position sensors
  • Analog and digital sensor interfacing and signal processing
  • Excellent communication skills both written and oral
  • Experience with Altium Designer
  • Experience with Systems and Electronic CAD and simulation tools (e.g.: MATLAB, SPICE, Labview, etc.
  • Printed circuit layout experience
  • FPGA design experience
  • Experience within the Medical Device or a highly regulated industry
  • Knowledge of Medical Device Verification and Validation for compliance with FDA guidance

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Engineering Technician

Summary:

This position is primarily responsible for utilizing state-of-the-art equipment for the development of life changing medical devices. The ideal candidate will be comfortable operating a variety of equipment including, but not limited to; lasers, injection molders, reflow machines as well as an array of test equipment while adhering to the quality requirements of the company. In addition, this position will work with the design and process teams to ideate, create, and build first prototypes. This individual is essential in the maturation of these prototypes and their progress through the development. Lastly, the technician must feel comfortable providing candid feedback to the development team to ensure success in later phases of the program.

Responsibilities:

  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Complies with company, quality and safety standards, policies and procedures.
  • Run equipment tests, collect data, and analyze data with the engineering team.
  • Make recommendations on how to improve the quality or efficiency of a process based on data and observation.
  • Assist in training employees on equipment and assembly skills.
  • Interact effectively and assist engineering in improving quality and solving problems.
  • Develop processes and procedures for projects to improve quality and cost.
  • Originate and maintain written technical descriptions of processes and procedures comprehensive in scope and understandable by the audience.
  • Represent engineering for Material Review Board concerning material dispositions.
  • Represent Engineering in cross functional teams as assigned.
  • Maintain compliance to procedures and regulatory requirements.
  • Understand and follow safety policies and practices, attend safety training and wear PPE as required.
  • Prepares Engineering Change Orders for processes and components.
  • Performs Corrective and Preventative Action tasks.
  • Complies with company, quality and safety standards, policies, and procedures
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or G.E.D. Certificate required.
  • Two-year technical degree in Engineering preferred.
  • Strong drive to learn, share and teach.
  • Understanding of and experience with mechanical equipment.
  • FDA, cGMP principles and practices, (ISO 9001, ISO 13485).
  • 3 Plus years’ experience in the engineering/manufacturing environment for medical devices.
  • In-depth understanding of one or more manufacturing processes is a plus.
  • Familiarity with Pro-E / CREO and or SolidWorks is preferred.
  • Strong computer skills associated with Microsoft software.
  • Ability to interpret technical drawing, blueprints, specification, and illustrations.
  • Ability to diagnose and solve problems with jobs in a timely manner.
  • Must be able to read, write and speak fluent English.
  • Excellent reading, writing, communication, and organizational skills.
  • Maintains performance with changing priorities under minimal supervision.
  • Possess strong team collaboration skills.
  • Must be able to make clear and accurate decisions.
  • Strong desire to learn and apply new technology.

Benefits:

  • Medical
  • Dental
  • Vision
  • Vacation/ Sick PTO
  • 401K

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Machinist I - Swiss

Summary:

This position is primarily responsible to maintain simple set-ups on presses or CNC equipment and have good working knowledge of the machine you are working on. Must exhibit the ability to produce quality workmanship consistently.

Responsibilities:

  • Accurately completes all department paperwork including job travelers, Inspection documentation, work packet information, and tooling request forms.
  • Understands, embraces, and follows Cirtec Medical workmanship specifications.
  • Uses knowledge of the functions of the machines, including tool and work offsets, to adjust them to ensure quality.
  • Regularly inspects parts according to process to ensure quality parts are being produced.
  • Properly uses all equipment and maintains a clean work area.
  • Uses inspection equipment as required.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or G.E.D. Certificate required.
  • Experience as a CNC Machinist or CNC education preferred.
  • Maintain routine production records.
  • Knowledge of trade tools, equipment, materials, micrometer, as well as methods and techniques used in safe machining operations.
  • Strong attention to quality.
  • Basic understand of geometric dimensions and tolerancing (GD&T), GMP and GDP preferred.
  • Good written and verbal communication skills.

Benefits:

  • Medical
  • Dental
  • Vision
  • Vacation/ Sick PTO
  • 401K

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Project Manager

Summary:

The Project Manager positioned is primarily responsible for managing and coordinating development and manufacturing transfer of complex components and finished medical devices.

Responsibilities:

  • Manages and coordinates development and manufacturing transfer of complex components, sub-assemblies and finished medical devices.
  • Generates and maintains detailed project plans, task lists and project risk registers that enable the team to execute project activities based on well-defined prioritization.
  • Coordinates activities across different functional groups to ensure successful completion of project goals and milestones.
  • Tracks project health in terms of schedule, budget, and technical risks and issues. Prepares and presents comprehensive project status reports to internal and external stakeholders.
  • Proactively anticipates project risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions.
  • Creates and maintains Design History file per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements.
  • Supports project team in establishing and maintaining product requirements and test plans.
  • Serves as the principal contact with external customers. Coordinates and directs customer meetings and visits, and day-to-day customer communication.
  • Manages internal resource allocation to meet program goals and milestones. Works with internal management to ensure appropriate resources have been assigned.
  • Reliable, consistent and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum BS in a relevant engineering discipline with at least 5 years of experience within the medical device industry.
  • Minimum 2 years of experience in project / program management of medical device development.
  • Experience with metals processing and Nitinol-based devices preferred but not required.
  • Must possess strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control.
  • Must be able to interpret technical drawings, product requirements, design specifications and relevant technical documents.
  • Ability to condense and communicate complex technical ideas, project status and risks to internal and external stakeholders.
  • Must have proficiency in MS Project and other MS Office software.
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral.
  • Willingness to travel, if required.

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Regulatory Affairs Specialist

Summary:

Our location in Brooklyn, Park, MN has an opportunity for a Senior Regulatory Affairs Specialist that is focused on the Cirtec SIMPLIFI™ Neuromodulation Solutions Platform.  As an individual contributor you will provide Regulatory Services for Cirtec and Cirtec customers using the SIMPLIFI platform.  This will include IDE and PMA submissions, PMA Supplements, Q-Subs, CE Mark submissions, FDA and Notified Body communications.

Responsibilities:

  • Determine and communicate submission and approval requirements.
  • Work with customers to compile, prepare, review, and submit regulatory submissions to authorities.
  • Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing strategies.
  • Assist with label development and review for compliance.
  • Evaluate applicable laws and regulations to determine impact on company activities.
  • Regulatory input for lifecycle planning.
  • Provide technical review of data or reports.
  • Coordinate regulatory documentation activities.
  • Identify and interpret relevant regulatory guidelines.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor of Science or equivalent, preferably in an engineering or quality discipline.
  • Class III device experience, preferably with Neurostimulation Active Implantable Medical Devices.
  • Expert knowledge of FDA and EU regulations.
  • Small company / startup experience.
  • Exemplary communication skills to collaborate and interface with others.
  • Impeccable attention to detail to oversee regulatory initiatives.
  • Software and cyber security product experience desired.
  • RAC Designation preferred.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position

Protective Clothing Required: None

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Project Manager

ABOUT THE COMPANY

Cirtec Medical is more than just another design shop or contract manufacturer, we offer a uniquely comprehensive range of vertically integrated capabilities. Cirtec Medical specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization.

Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers’ devices to market.  If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you!

You are a part of:

The Engineering team consists of engineers with diverse backgrounds and expertise.  The Engineering team works in close collaboration with Operations, R&D, and Purchasing. You will be involved in the design, development, documentation and validation of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

JOB SUMMARY

The Project Manager position is primarily responsible for managing and coordinating product development and manufacturing transfer of complex components and finished medical devices.  This job offers an opportunity to work with dynamic teams, multiple projects, technologies and lifesaving products.

Responsibilities:

  • Manages and coordinates development and manufacturing transfer of complex components, sub-assemblies and finished medical devices.
  • Generates and maintains detailed project plans, task lists and project risk registers that enable the team to execute project activities based on well-defined prioritization.
  • Coordinates activities across different functional groups to ensure successful completion of project goals and milestones.
  • Tracks project health in terms of schedule, budget, and technical risks and issues. Prepares and presents comprehensive project status reports to internal and external stakeholders.
  • Proactively anticipates project risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions
  • Creates and maintains Design History file per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements.
  • Supports project team in establishing and maintaining product requirements and test plans.
  • Serves as the principal contact with external customers. Coordinates and directs customer meetings and visits, and day-to-day customer communication.
  • Manages internal resource allocation to meet program goals and milestones. Works with internal management to ensure appropriate resources have been assigned.
  • Reliable, consistent and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

To succeed in this role, you should have the following skills and experience:

Required Qualifications:

  • Minimum BS in a relevant engineering discipline.
  • At least 5 years of experience within the medical device or regulated industry experience.
  • Minimum 2 years of experience in project / program management of medical device development.
  • At least 2 years of product development experience.
  • Strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control.
  • Ability to interpret technical drawings, product requirements, design specifications and relevant technical documents.
  • Ability to condense and communicate complex technical ideas, project status and risks to internal and external stakeholders.
  • Proficient in MS Project and other MS Office software.
  • Be able to read, write and speak fluent English, and possess excellent communication skills, both written and oral.

Preferred Qualifications:

  • Experience with metals processing and Nitinol-based devices.
  • Willingness to travel, if required

WHAT WE OFFER

In return, we offer you:

  • A fast-paced work environment
  • Clean, and well-lit production areas
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a company match

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Process Development Engineer I

Summary:

The Engineer I, Process Development is position is primarily responsible for a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities:

  • Attends and arranges project meetings to discuss current and future design and development initiatives
  • Track and communicate issues, status on assigned action items that would affect timelines and budget
  • Can have responsibility for any of the following project inputs:
    • Feasibility builds, documentation, and testing
    • Equipment selection
    • Process development and documentation
    • Device Verification samples and testing
    • Operator training
    • Process Failure Mode Effects Analysis
    • Clinical builds
    • Process Validation
  • May have involvement in the design, development, and validation requirements of projects, including:
    • Product design and specification creation, including mechanical and electrical components, assemblies, and packaging.
    • Materials sourcing and device prototyping.
    • Design verification and validation activities, including data for regulatory submission
    • Manufacturing transfer and support of existing product lines as applicable
  • Reliable, consistent and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • A Bachelor’s degree in an engineering discipline and minimum 2 years appropriate work experience.
  • Experience in an engineering/manufacturing environment with mechanical, tool design, and manufacturing processes preferred.
  • Must maintain high ethical standards.
  • Must demonstrate good organizational skills.
  • Must be able to read, write and speak fluent English.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications & illustrations.
  • Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information.
  • Ability to learn and apply new technology.
  • Technical report preparation and good small group presentation skills.
  • Willingness to travel, if required.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate.  The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Material Coordinator

Summary:

This position is primarily responsible for inventory control, job order material usage reconciliation, job closings, and inventory reconciliation. Coordinating with purchasing and production to ensure the inventory is accurate and appropriate to meet demands.  Perform duties within the production and inventory control department as required.

Responsibilities:

  • Review jobs requiring materials via the ERP system.
  • Issue materials to assigned jobs physically and in ERP system.
  • Return materials from completed jobs physically and in ERP system.
  • Perform monthly cycle count in assigned area(s).
  • Communicate any material shortages to appropriate departments as needed.
  • Prepare outgoing shipments to subcontract suppliers.
  • Close all production jobs, verifying material issues before doing so.
  • Copy all documents necessary for and file into the DHR file.
  • Prepare closed jobs with necessary documentation for AR invoicing.
  • Provide customers with Inventory reports of their material as requested.
  • Create “customer supplied” materials purchase orders.
  • Support customer service with releasing job orders to the floor.
  • Maintain and monitor manual or computerized inventory control system for raw materials and finished stock.
  • Investigate all discrepancies.
  • Perform cycle counts and assist with annual physical inventory as required.
  • Support or provide back-up to Shipping, Production and Inventory Control functions as required.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum five years’ experience in a manufacturing environment, two years of which include operation of an automated inventory control system.
  • Inventory management and control disciplines
  • Computerized inventory record keeping systems

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Machinist I - Swiss

Summary:

This position is primarily responsible to maintain simple set-ups on presses or CNC equipment and have good working knowledge of the machine you are working on. Must exhibit the ability to produce quality workmanship consistently.

Responsibilities:

  • Operate Swiss CNC Machines
  • Accurately completes all department paperwork including job travelers, Inspection documentation, work packet information, and tooling request forms.
  • Understands, embraces, and follows Cirtec Medical workmanship specifications.
  • Uses knowledge of the functions of the machines, including tool and work offsets, to adjust them to ensure quality.
  • Regularly inspects parts according to process to ensure quality parts are being produced.
  • Properly uses all equipment and maintains a clean work area.
  • Uses inspection equipment as required.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or G.E.D. Certificate required
  • Experience as a CNC Machinist or CNC education preferred
  • Maintain routine production records.
  • Knowledge of trade tools, equipment, materials, micrometer, as well as methods and techniques used in safe machining operations.
  • Strong attention to quality
  • Basic understand of geometric dimensions and tolerancing (GD&T), GMP and GDP preferred
  • Good written and verbal communication skills.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Operator Assembler, Laser

Summary:

This position is primarily responsible for assembling product, associated systems, and basic operating of laser used in the manufacturing of products sold to our customers. This position is expected to work with and assist in the training of lower-level operators to effectively meet or exceed expectations for product quality and production rates. It is also expected that in this position there will continue to build their skills with Technicians along with taking tasks and direction from the Engineering departments. In this position you must be proficient in setting up and operating workstations perform visual and dimensional inspections needed to manufacture the products at Cirtec.

Responsibilities:

  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Has the responsibility of following established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from Team Lead/Supervisor.
  • Will be proficient in the task of loading components into product specific tools.
  • Primary function, processing, and product fabrication.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • Performs complex workstation set up and troubleshooting tasks.
  • Performs various dimensional inspection using specific gauges, dimensional inspection systems, verniers and micrometers.
  • Provides training on processes to team members
  • Has the standard skills of operating manufacturing workstations including most laser systems used in the manufacture of products sold to our customers.
  • Proficient in the operation of computerized motion controllers.
  • Knowledge of welding operations.
  • Ability to perform workstation set up requirements for any type of processing job using existing tooling and established parameters.
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions.
  • Provides direction within the manufacturing cell to associates assigned to assist them.
  • Assists Quality Control with inspection duties as required.
  • Possesses the ability to accurately follow operating manuals, maintenance instructions, Standard operating procedures & work instructions.
  • Operate effectively and maintain professionalism in an environment of deadlines and high workloads and adjust schedule or work hours to meet changes in priorities.
  • Performs additional duties as required under the direction of the Production Team Leader/Supervisor.
  • Responsible for recognizing quality issues and communicating issues to the Quality and/ or Production Supervision.
  • Acts as a resource during audits or customer visits for questions and answers or practical demonstrations.
  • When assisting upper-level Technician or Engineer accurately document development activities in a lab notebook.
  • Ability to provide input to Engineering and upper-level Technicians in regard to tool design and/or troubleshooting processes.
  • Assists in ensuring the accuracy of Process Control Documents, Parameter Sheets, Work Instructions, and Standard Operating Procedures.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or General Education Degree (GED) is required
  • 4-6 years’ experience in medical device industry or equivalent training preferred.
  • Be able to read, write and speak fluent English. Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail
  • Knowledge of ISO & FDA requirements a plus.
  • Experience with LEAN manufacturing a plus.
  • Ability to work in environment subject to fluctuations in heat, humidity, fumes, odors, dust, and noise.
  • Ability to provide detailed information to assist sustaining engineering in determining root cause in order to identify the appropriate corrective action.
  • Strong interpersonal skills to establish and maintain cooperative and effective working relationships.
  • Good written and verbal communication skills.
  • Meets all requirements of Operator/Assembler Il
  • Knowledge of how to set up and operate workstations.
  • Moderate computer skills, including the MS Office suite.
  • Must be able to interpret technical drawings, blueprints, specifications & illustrations.
  • Strong analytical skills and must have the ability to obtain secondary research information from the Internet or alternate sources.
  • Ability to learn and apply new technology.
  • Technical report preparation
  • Ability to provide information to engineers for determining root cause in order to identify the appropriate corrective actions.
  • Knowledge of performing visual and dimensional inspections.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Process Development Engineer I

Summary:

The Engineer I, Process Development is position is primarily responsible for a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities:

  • Attends and arranges project meetings to discuss current and future design and development initiatives
  • Track and communicate issues, status on assigned action items that would affect timelines and budget
  • Can have responsibility for any of the following project inputs:
    • Feasibility builds, documentation, and testing
    • Equipment selection
    • Process development and documentation
    • Device Verification samples and testing
    • Operator training
    • Process Failure Mode Effects Analysis
    • Clinical builds
    • Process Validation
  • May be involved in the design, development, and validation requirements of projects, including:
    • Product design and specification creation, including mechanical and electrical components, assemblies, and packaging.
    • Materials sourcing and device prototyping.
    • Design verification and validation activities, including data for regulatory submission.
    • Manufacturing transfer and support of existing product lines as applicable.
  • Reliable, consistent and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • A Bachelor’s degree in an engineering discipline and minimum 2 years of appropriate work experience; or Associate’s degree in engineering discipline and a minimum 5 years of appropriate work experience; or a minimum 5-7 years of relevant work experience; or equivalent.
  • Experience in an engineering/manufacturing environment with mechanical, tool design, and manufacturing processes preferred.
  • Must maintain high ethical standards.
  • Must demonstrate good organizational skills.
  • Must be able to read, write and speak fluent English.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications & illustrations.
  • Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information.
  • Ability to learn and apply new technology.
  • Technical report preparation and good small group presentation skills.
  • Willingness to travel, if required.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Engineer, Tool Design - Stamping

Summary:

The Engineer, Tool Design position is primarily responsible to provide support to engineering, production, and quality while adhering to quality system requirements. For developing and improving tooling and fixtures from concepts and sketches into drafting prints while complying with industry drafting standards. Activities completed in this position must be implemented in accordance with Good Manufacturing Practices, Good Documentation Practices, ISO and FDA requirements.

Responsibilities:

  • Generate 3D models and Engineering drawings.
  • Create detailed tooling, gage, and fixture engineering drawings independently and with input from the subject matter expert or engineer.
  • Review engineering drawings to ensure adherence to specifications and standards.
  • Perform dimensional stack-ups, making adjustments as needed for best-fits.
  • Manage workload to support various departments.
  • Review external customer CAD files for drawing requirements and modify as needed to support internal customers.
  • Initiate and or review ECO’s for Drawing releases and revisions.
  • Work effectively with other departments to resolve drawing discrepancies.
  • Work with product development teams to ensure compliance when transferring documents to production releases.
  • Maintain strict adherence for multiple CAD file relationships, models, assemblies, libraries and symbols.
  • Maintain compliance to procedures and regulatory requirements.
  • Understand and follow safety policies and practices, attend safety training and wear PPE as required.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Reliable, consistent and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • FDA, cGMP, GDP principles and practices, (ISO 9001, ISO 13485).
  • Three-plus years’ experience in the engineering/manufacturing environment (Machining, Finishing, and assembly) for medical devices related to drafting and tool design.
  • Associates degree in an Engineering discipline or related field.
  • Proficiency with Solidworks required with Pro-E/CREO experience.
  • Solid working knowledge of dimensioning and Geometric tolerances, GD&T.
  • Blueprint reading.
  • Computer skills associated with Microsoft software.
  • Must be able to read, write and speak fluent English.
  • Excellent reading, writing, communication, and organizational skills.
  • Maintains performance with changing priorities under minimal supervision.
  • Possess team collaboration skills.
  • Must be able to make clear and accurate decisions.
  • Strong mechanical aptitude.
  • PDM file management experience preferred.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Operator Assembler

Summary:

This position is primarily responsible for assembling product, associated systems, and basic operating of laser used in the manufacturing of products sold to our customers.  This position is expected to work with and assist in the training of lower-level operators to effectively meet or exceed expectations for product quality and production rates. It is also expected that in this position there will continue to build their skills with Technicians along with taking tasks and direction from the Engineering departments. In this position you must be proficient in setting up and operating workstations perform visual and dimensional inspections needed to manufacture the products at Cirtec.

Responsibilities:

  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Has the responsibility of following established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from Team Lead/Supervisor.
  • Will be proficient in the task of loading components into product specific tools.
  • Primary function, processing, and product fabrication.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • Performs complex workstation set up and troubleshooting tasks.
  • Performs various dimensional inspection using specific gauges, dimensional inspection systems, verniers and micrometers.
  • Provides training on processes to team members.
  • Has the standard skills of operating manufacturing workstations including most laser systems used in the manufacture of products sold to our customers.
  • Proficient in the operation of computerized motion controllers.
  • Knowledge of welding operations.
  • Ability to perform workstation set up requirements for any type of processing job using existing tooling and established parameters.
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions.
  • Provides direction within the manufacturing cell to associates assigned to assist them.
  • Assists Quality Control with inspection duties as required.
  • Possesses the ability to accurately follow operating manuals, maintenance instructions, Standard operating procedures & work instructions.
  • Operate effectively and maintain professionalism in an environment of deadlines and high workloads and adjust schedule or work hours to meet changes in priorities.
  • Performs additional duties as required under the direction of the Production Team Leader/Supervisor.
  • Responsible for recognizing quality issues and communicating issues to the Quality and/ or Production Supervision.
  • Acts as a resource during audits or customer visits for questions and answers or practical demonstrations.
  • When assisting upper-level Technician or Engineer accurately document development activities in a lab notebook.
  • Ability to provide input to Engineering and upper-level Technicians in regard to tool design and/or troubleshooting processes.
  • Assists in ensuring the accuracy of Process Control Documents, Parameter Sheets, Work Instructions, and Standard Operating Procedures.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or General Education Degree (GED) is required.
  • 4-6 years’ experience in medical device industry or equivalent training preferred.
  • Be able to read, write and speak fluent English.
  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail.
  • Knowledge of ISO & FDA requirements a plus.
  • Experience with LEAN manufacturing a plus.
  • Ability to work in environment subject to fluctuations in heat, humidity, fumes, odors, dust, and noise.
  • Ability to provide detailed information to assist sustaining engineering in determining root cause in order to identify the appropriate corrective action.
  • Strong interpersonal skills to establish and maintain cooperative and effective working relationships.
  • Good written and verbal communication skills.
  • Meets all requirements of Operator/Assembler II.
  • Knowledge of how to set up and operate workstations.
  • Moderate computer skills, including the MS Office suite.
  • Must be able to interpret technical drawings, blueprints, specifications & illustrations.
  • Strong analytical skills and must have the ability to obtain secondary research information from the Internet or alternate sources.
  • Ability to learn and apply new technology.
  • Technical report preparation.
  • Ability to provide information to engineers for determining root cause in order to identify the appropriate corrective actions.
  • Knowledge of performing visual and dimensional inspections.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Operator Assembler II

Summary:

This position is primarily responsible for operating workstations and associated systems used in the manufacturing of products sold to our customers. This position is expected to work with lower-level Operators along with higher level Technicians to effectively meet or exceed expectations for product quality and production rates. In this position they must have a basic knowledge of how to set up and operate workstations, perform visual and dimensional inspections needed to manufacture the products at Cirtec.

Responsibilities:

  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Has the responsibility of following established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from upper-level operators assigned to that cell.
  • Will be proficient in the task of loading components into product specific tools.
  • Primary function, processing, and product fabrication.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • Performs basic workstation set up and troubleshooting tasks.
  • Performs various dimensional inspection using specific gauges, dimensional inspection systems, verniers and micrometers.
  • May perform weld operations.
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions.
  • Provides direction within the manufacturing cell to associates assigned to assist them.
  • Assists Quality Control with inspection duties as required.
  • Recognizes quality issues and communicates these issues to Quality and/or Supervisor.
  • Must accurately document all work performed on inspection reports and customer travelers.
  • Assists in packaging of finished goods as needed.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or General Education Degree (GED) is required
  • 3-5 years’ experience in medical device industry, preferred but not required.
  • Be able to read, write and speak fluent English.
  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail
  • Meets all requirements of Operator/Assembler I
  • Knowledge of how to set up and operate workstations.
  • Ability to provide information to engineers for determining root cause in order to identify the appropriate corrective actions.
  • Knowledge of performing visual and dimensional inspections.
  • Strong interpersonal skills to establish and maintain cooperative and effective working relationships.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Supply Chain Coordinator

Summary:

The Supply Chain Coordinator assists the Planning, Buying, Materials and Operations teams in the flow of production.

Responsibilities:

  • Monitors and moves Work in Process inventory by using daily reporting tools.
  • Uses daily reporting tools to monitor and manage daily production, work-in-process, and shipped goods.
  • Communicates and tracks material shortages and equipment downtime as needed.
  • Monitors and manages purchase orders as required.
  • Executes daily and weekly reporting to support the operations and supply chain teams.
  • Assists Customer Service in communicating order status.
  • Assists Buyers and Planners in master data management. Ensures transactional data is correct. Troubleshoots reporting errors for materials or labor as required.
  • May perform basic scheduling tasks such as releasing orders, monitoring safety stock, monitoring order status through ERP systems.
  • Assist Planning or Buying teams with Quality Control functions such as executing Engineering Change Notifications, participating in the Material Review Board.
  • May issue materials to production jobs and may perform cycle counts to ensure accurate inventory.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or GED required, college experience a plus.
  • 3+ years’ experience in materials management desired.
  • Previous experience in an ISO or FDA regulated industry is strongly preferred.
  • Be able to read, write and speak fluent English.
  • Must have strong written and verbal communication skills and be able to speak in front of a small group.
  • Attention to detail.
  • Computer literate (MS Office, ERP).
  • Ability to interpret written and verbal work instructions.
  • Must have good organizational and time management skills.
  • Understanding of scheduling and the importance of details, accuracy, and meeting deadlines.
  • Continually looks for Process Improvement opportunities.
  • Accurate data entry skills and understanding of Inventory Control.
  • Knows how to work safely and looks for opportunities to improve safety.

 PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee will be on their feet for entire shift. The employee must be able to lift 50 pounds. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

WORKING ENVIRONMENT

Work is performed in a warehouse and cleanroom environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Inspector II

Summary:

This position is primarily responsible for performing receiving, first piece, in-process and final inspection or test on a wide variety of parts and document results. Indicate inspection status, maintain product traceability and non-conforming material control. Participate in internal audits, statistical process control and assist control of process documentation, records, and equipment calibration.

Responsibilities:

  • Inspect, measure and/or test incoming parts, production first piece, in-process and final product, record results and notify appropriate personnel.
  • Indicate inspection status of parts with assigned labels and stamps.
  • Maintain product identification and traceability.
  • Control non-conforming product in accordance with documented procedures and verify timely corrective and preventative action.
  • Protect product during handling and storage in the performance of work.
  • Monitor factory environmental conditions, record data and alert adverse conditions.
  • Assist with distribution and control of process documentation and quality records.
  • Assist with control of measuring and test equipment calibration.
  • Participate in internal quality audits to verify compliance with documented procedures and specifications, record results and verify audit corrective action.
  • Assist with statistical methods of verifying and controlling process capability.
  • Provide input when required to quality planning for specific projects and products.
  • Provide leadership to production personnel on quality issues.
  • Comply with and reinforce the requirements of the Cirtec Quality System Manual and Standard Operating Procedures, ISO 9002, FDA Quality System Regulations, and other customer standards.
  • Follow Occupational Safety and Health regulations, including laser safety practices.
  • Other agreed duties within the Quality Department consistent with training, qualification, and experience.
  • Provide Quality Support for the disposition of discrepant material.
  • Provide leadership to production personnel in relation to quality.
  • Provide Quality Control support to Manufacturing & Engineering.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English
  • High school diploma or GED
  • 3-5 years’ minimum experience in manufacturing, preferably medical devices, with increasing responsibility or a minimum of 5 years’ experience in a manufacturing environment.
  • Certificate/s of training related to this field of work (medical or quality assurance)
  • 3 years’ experience as a Quality Control Inspector
  • Proven experience in inspection and documenting results
  • Able to demonstrate competence in interpreting technical drawings & specifications
  • Proficient in the use of microscopes, measuring and test equipment
  • Able to check dimensions, squareness, hole locations, surface relationships, finish material defects and mechanical strength of product following appropriate training
  • Have experience in the use of PC’s and Microsoft Office software applications

Additional Qualifications:

  • Prefer experience and familiarity with operations such as cleanroom manufacturing, Swiss machining, milling, stamping, laser cutting, laser welding, coiling, crimping, swaging, adhesive bonding/backfill, liquid silicone & thermoplastic injection molding, annealing, and general mechanical assembly

WORKING ENVIRONMENT

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Design & Development Quality Engineer II

Summary:

The Quality Design & Development Engineer II is responsible for providing support to product development teams and sustaining manufacturing/operations teams.  This individual will be expected to apply design control principles and techniques for medical devices. As a member of one or more cross-functional teams, this individual will ensure products are designed and developed in accordance with applicable regulatory requirements, customer requirements, and company policy.

Responsibilities:

  • Perform Design Quality Engineering activities throughout the design, development and production of medical devices to ensure compliance to company’s Design Control procedures and regulatory requirements (specifically FDA 21 CFR 820 and ISO 13485).
  • Demonstrated understanding and application of regulations and standards (specifically ISO 14971, 2017/745 EUMDR, IEC 60601, IEC 10993).
  • Create, review and/or approve technical Design Control documentation to facilitate design, development, and product verification testing of medical devices in collaboration with cross-functional engineering teams.
  • Create and execute Quality Plans for Product Design and Development projects.
  • Represent Quality Engineering in technical design and phase end reviews.
  • Develop and perform Design of Experiments (DOE).
  • Develop and validate test methods.
  • Develop sampling plans and acceptance criteria for product testing and inspection methods using appropriate statistical techniques.
  • Lead and/or participate in risk management activities, develop Risk Management Plans and Reports, perform Hazards Analysis and FMEAs (Failure Mode Effects Analysis) to evaluate and ensure product safety and functionality.
  • Conduct and/or support root cause investigations, develop and implement corrective and preventative actions for quality system and product related nonconformance’s.
  • Support quality system improvement initiatives and CAPA’s.
  • Responsible for the assessment of technical standards, labeling and technical file requirements.
  • Responsible for the assessment of component and system level specifications relative to customer needs and product performance specifications.
  • Perform requirement flow down analysis on critical to quality product performance specifications down to components and process.
  • Apply Design for Reliability and Manufacturability tools and techniques.
  • Support for multiple projects, balancing priorities and resources to meet both project and management expectations.
  • Prepare reports required by the project or department management.
  • Lead and/or participate in reviews and communications with customers.
  • Reliable, consistent and punctual attendance is an essential function of the job
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • B.S. Degree in Engineering or associated fields, or equivalent industry experience.
  • 2+ years’ experience in design, quality, or reliability engineering in medical devices.
  • Knowledge of quality assurance and regulatory compliance including Quality System Standards and Regulations.
  • Knowledge of product development processes and methods.
  • Knowledge of systems engineering discipline, Technical Standards, Hazard Analysis and Failure Mode and Effects Analysis (FMEA), Qualification, Test Method and Process Validation.
  • Knowledge in the application of risk management.
  • ASQ Certification preferred.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Assembler II

Summary:

Develops building processes and testing of prototypes. The Assembler has internal contacts with engineering department personnel regarding ideas, drawings, and products, development of designs, to resolve problems and to provide prototypes.

Essential Functions:

  • Support Engineers and technicians on development products relating to defined customer needs or as possible proprietary items. This also may include the adaptation of existing designs to new-customer applications.  These designs may be in the form of freehand sketches or final detail drawings, depending on timing and available drafting time.
  • Construction of prototypes and development builds to meet customer and internal requirements.
  • Testing of new-product prototypes to verify product reliability.
  • Notes process steps and parameters.
  • An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Additional Responsibilities:

  • Assists the engineering department in regard to product redesign to resolve product or production difficulties.
  • Performs other duties when required or requested.

Education & Experience:

  • Must be familiar with a variety of manufacturing processes and materials.
  • Three (3) years’ on-the-job experience as product builder.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Punch Press Setup/Operator II

Summary:

This position is primarily responsible to set up and maintain all set-ups on presses or CNC equipment. A Punch Press Setup/Operator II should be self-motivated and ensure the product is done on time and of the highest quality possible. Has excellent trouble shooting ability on both the machine and tooling and can assist the supervisor and/or lead person as well as the programmers with the operation of the department.

Responsibilities:

  • Accurately completes all department paperwork including job travelers, Inspection documentation, work packet information, and tooling request forms
  • Builds quality parts using good working knowledge of blueprints
  • Understands, embraces and follows Cirtec Medical workmanship specs
  • May be required to change tools
  • Actively participates in improving quality programs and team meetings
  • Uses knowledge of the functions of the machines, including tool and work offsets, to adjust them to ensure quality
  • Regularly inspects parts according to process to ensure quality parts are being produced
  • Properly uses all equipment and maintains a clean work area
  • Uses inspection equipment as required
  • Solves problems of quality and efficiency working within the team
  • Maintains a high level of efficient production
  • Maintains a no reject quality level
  • Effectively resolves all problems that arise or seeks assistance in a timely manner
  • Interacts effectively with engineering and quality individuals to solve problems
  • Continually train co-workers to encourage individual growth within company
  • Sets up and runs all jobs within the department
  • Promotes good morale and productivity on the team
  • Increases production and streamlines set-ups for optimum efficiencies and quality
  • Trouble-shoots quality problems by effectively utilizing process controls and corrective actions
  • Maintains a very high level of cleanliness and organization
  • Complies with company, quality and safety standards, policies, and procedures
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Meets all criteria for Machinist I
  • High school diploma or GED required
  • Minimum of 2 years Punch Press experience including setups and troubleshooting required
  • Read, write, and speak fluent English
  • Ability to perform calculations with shop Math
  • Inspection experience using micrometers, calipers, dial indicators, and vision systems
  • Medical Device or component manufacturing experience preferred
  • Possesses extensive knowledge of all phases of machining and equipment
  • Demonstrates good decision making and problem-solving skills
  • Full comprehension of geometric tolerancing
  • On-going job training
  • For Press Room:
    • 2+ years minimum experience setting up and operating automatic mechanical punch presses and various other types of equipment
    • Ability to perform a variety of moderate stamping, drawing and forming operations, which includes the use of compound, combination and some progressive dies
    • Able to setup a variety of different tools from simple to complex minimal supervision

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Inspector I

Summary:

This position is primarily responsible for performing receiving, first piece, in-process and final inspection or test on a wide variety of parts and document results. Indicate inspection status, maintain product traceability and non-conforming material control. Participate in internal audits, statistical process control and assist control of process documentation, records, and equipment calibration.

Responsibilities:

  • Inspect, measure and/or test incoming parts, production first piece, in-process and final product, record results and notify appropriate personnel.
  • Indicate inspection status of parts with assigned labels and stamps.
  • Maintain product identification and traceability.
  • Control non-conforming product in accordance with documented procedures and verify timely corrective and preventative action.
  • Protect product during handling and storage in the performance of work.
  • Monitor factory environmental conditions, record data and alert adverse conditions.
  • Assist with distribution and control of process documentation and quality records.
  • Assist with control of measuring and test equipment calibration.
  • Participate in internal quality audits to verify compliance with documented procedures and specifications, record results and verify audit corrective action.
  • Assist with statistical methods of verifying and controlling process capability.
  • Provide input when required to quality planning for specific projects and products.
  • Provide leadership to production personnel on quality issues.
  • Comply with and reinforce the requirements of the Cirtec Quality System Manual and Standard Operating Procedures, ISO 9002, FDA Quality System Regulations, and other customer standards.
  • Follow Occupational Safety and Health regulations, including laser safety practices.
  • Other agreed duties within the Quality Department consistent with training, qualification, and experience.
  • Provide Quality Support for the disposition of discrepant material.
  • Provide leadership to production personnel in relation to quality.
  • Provide Quality Control support to Manufacturing & Engineering.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English.
  • High school diploma or GED.
  • 3-5years’minimum experience in manufacturing, preferably medical devices, with increasing responsibility or a minimum of 5 years’ experience in a manufacturing environment.
  • Certificate/s of training related to this field of work (medical or quality assurance).
  • 3 years’ experience as a Quality Control Inspector.
  • Proven experience in inspection and documenting results.
  • Able to demonstrate competence in interpreting technical drawings & specifications.
  • Proficient in the use of microscopes, measuring and test equipment.
  • Able to check dimensions, squareness, hole locations, surface relationships, finish material defects and mechanical strength of product following appropriate training.
  • Have experience in the use of PC’s and Microsoft Office software applications.
  • Brooklyn Park Additional Qualifications:
  • Prefer experience and familiarity with operations such as cleanroom manufacturing, Swiss machining, milling, stamping, laser cutting, laser welding, coiling, crimping, swaging, adhesive bonding/backfill, liquid silicone & thermoplastic injection molding, annealing, and general mechanical assembly.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Documentation Retention Specialist

Summary:

The position will be responsible for ensuring operational adherence and compliance to Cirtec Medical’s Quality Management System (QMS) Record Retention requirements. This may include Record Control Systems, maintaining paper training records, Shipping documentation support, Internal & External Auditing documentation support, and training and education support.

Responsibilities:

  • Review Production travelers for accuracy, ensuring all fields are completed, that data is accurate, and ensuring that mistakes are correctly amended.
  • Create inspection shipping documentation packets.
  • Review material specifications from the customer print verses the material used during manufacturing. Ensure that all chemical compositions and ASTMs are met.
  • Create SPC charts when applicable.
  • Review and maintain all outside service documents that need to ship with paperwork packet.
  • Create a “Certificate of Compliance” for each shipment.
  • Create secondary compliance paperwork for processes completed at Cirtec Medical.
  • Create history cards.
  • Create raw data sheets for customers when required.
  • Responsible for all shipping documentation entry and storage.
  • Enter all shipping information into database after shipping is complete.
  • Organize all files into weekly packets.
  • Perform bin counts by team for each weekly packet to be used for internal quality metrics.
  • Archive all packets in an orderly fashion.
  • Provide support to Quality Documentation Specialists during internal and external audits.
  • Provide support to Quality Documentation Specialist training creating QMS.
  • File and maintain other Quality documents as required.
  • Ensure compliance to regulatory standards and requirements as applicable.
  • Know and adhere to Cirtec Medical’s Quality Management System and its requirements.
  • Present/communicate the status of materials at any time to the Supervisor/Manager.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High School Diploma, GED, or equivalent directly transferrable work experience (Prefer Manufacturing or Engineering discipline) required.
  • Minimum of 1-4 years of experience in a professional workplace environment required.
  • Post-Secondary education/training/certification coursework (Manufacturing or Engineering discipline) preferred.
  • Quality certification(s) (e.g. ASQ CQT, CQI, etc.) preferred.
  • Class I, II and/or III Medical Device manufacturing experience preferred.
  • Knowledge of, and experience with, GMP/ISO Standards preferred.
  • Must be able to speak, read and write English.
  • Proficient in computer use and general office software (MS Office, Outlook, Work, Excel).
  • Ability to work with a wide variety of functional areas including Engineering, Manufacturing and Quality Assurance.
  • Must be a self-starter with ability to work both independently and as part of a team.

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Director, Operations

Summary:

The Director of Operations is responsible for directing and coordinating the daily operations in manufacturing and ensure the business unit is managed and performing efficiently and effectively. This role is dedicated to effectively manages resources along with developing efficiency strategies to ensure the plant meets production goals and standards at minimal manufacturing costs. This position is focused on increasing levels of customer and employee satisfaction while improving the efficiency of manpower, materials and machines. The Director of Operations is a member of the Production Business Team (PBT) and a member of the functional manager’s group.

Responsibilities:

  • Responsible for leading and managing multiple production groups and managers including oversight of all production activities on multiple product departments.
  • Strategically and operationally drive the company’s production short- and long-term goals and initiatives.
  • Participate in strategic forums and monthly business reviews.
  • Prioritize and balance short-term needs with long-term strategic and tactical initiatives.
  • Provide leadership and direction to 300± employees in manufacturing and operations departments.
  • Develop, revise, and ensure accuracy of short-term and long-term production schedules and plans to ensure on-time shipments, maximize efficiency, continuously increase throughput (to peak capacity) and optimize labor resources.
  • Accountable for the delivery of product, meeting revenue goals and assuring the organization can effectively support our customer’s requirements.
  • Manage Annual Operating Plan necessary to meet goals; ensure budget is tracked and maintained.
  • Manage both the new product introduction into manufacturing and the production build of multiple diverse products.
  • Responsible for P&L in regard to meeting budget costs for each product line (includes, direct labor, indirect labor, scrap).
  • Maintain and ensure compliance with production controls and quality procedures, regulatory requirements, and all established safety practices and guidelines.
  • Build a homogeneous culture where all employees are in pursuit of exceeding expectations and achieving excellence in everything we do, including the implementation of Continuous Improvement practices and the dedication to quality.
  • Mentor associates and foster a learning and growth environment. Perform evaluations at regular intervals.
  • Support sales team by meeting with customers and providing input and support on proposals and sustained production contracts.
  • Serve as secondary contact with clients; instilling confidence in our technical capabilities and quality products.
  • Responsible for reviewing the Quality Management System for adequacy, effectiveness and suitability through attending, participating and assigning action items at the Management Review meetings.
  • Build an operations team that drives accountability.
  • Serve as manufacturing point person for internal audits and external regulatory inspections, and operations approval.
  • Analyzes the manufacturing demand to develop the staffing and equipment resources necessary to meet the output requirements while improving overall efficiency and optimizing capacity.
  • Ensure team is performing under the Cirtec quality system and with good engineering practices.
  • Ensure that projects stay on schedule and are fully documented as required by medical device regulatory agencies.
  • Manage day-to-day oversight of manufacturing operation for assigned customers after product release as necessary.
  • Hire, develop and review staff in performance management, quality operations, training initiatives, and business process improvement.
  • Reliable, consistent and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • A Bachelors’ degree in business administration or in an engineering discipline (or equivalent).
  • 10+ years operations experience with 5+ years’ experience managing a multiple/high-mix environment including high-technology operations, with preference for medical device.
  • Contract manufacturing experience preferred.
  • Demonstrated knowledge of leadership principles and practices.
  • Strong analytical skills; must be able to obtain and evaluate secondary research information.
  • Ability to meet deadlines and manage projects across many departments.
  • Ability to handle multiple projects and customers at any given time.
  • Excellent oral and written communication skills at all levels for technical personnel and customer contact.
  • Operate effectively and maintain professionalism in an environment of deadlines and high workloads.
  • Experience with FDA QSR’s, ISO13485 for medical devices and ISO 9001:2000.
  • Demonstrated skills with project management tools, methodologies and problem solving.
  • Demonstrated success in leading and managing people in a team-based environment.
  • Must maintain high ethical standards.
  • Must demonstrate good organizational skills.
  • Must be able to read, write and speak fluent English.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Ability to learn and apply new technology.
  • Willingness to travel, if required.

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Inspector II

Summary:

This position is primarily responsible for performing receiving, first piece, in-process and final inspection or test on a wide variety of parts and document results. Indicate inspection status, maintain product traceability and non-conforming material control. Participate in internal audits, statistical process control and assist control of process documentation, records, and equipment calibration.

Responsibilities:

  • Inspect, measure and/or test incoming parts, production first piece, in-process and final product, record results and notify appropriate personnel.
  • Indicate inspection status of parts with assigned labels and stamps.
  • Maintain product identification and traceability.
  • Control non-conforming product in accordance with documented procedures and verify timely corrective and preventative action.
  • Protect product during handling and storage in the performance of work.
  • Monitor factory environmental conditions, record data and alert adverse conditions.
  • Assist with distribution and control of process documentation and quality records.
  • Assist with control of measuring and test equipment calibration.
  • Participate in internal quality audits to verify compliance with documented procedures and specifications, record results and verify audit corrective action.
  • Assist with statistical methods of verifying and controlling process capability.
  • Provide input when required to quality planning for specific projects and products.
  • Provide leadership to production personnel on quality issues.
  • Comply with and reinforce the requirements of the Cirtec Quality System Manual and Standard Operating Procedures, ISO 9002, FDA Quality System Regulations, and other customer standards.
  • Follow Occupational Safety and Health regulations, including laser safety practices.
  • Other agreed duties within the Quality Department consistent with training, qualification, and experience.
  • Provide leadership to production personnel in relation to quality.
  • Provide Quality Control support to Manufacturing & Engineering.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English
  • High school diploma or GED
  • 3-5 years’ minimum experience in manufacturing, preferably medical devices, with increasing responsibility or a minimum of 5 years’ experience in a manufacturing environment.
  • Certificate/s of training related to this field of work (medical or quality assurance)
  • 3 years’ experience as a Quality Control Inspector
  • Proven experience in inspection and documenting results
  • Able to demonstrate competence in interpreting technical drawings & specifications
  • Proficient in the use of microscopes, measuring and test equipment
  • Able to check dimensions, squareness, hole locations, surface relationships, finish material defects and mechanical strength of product following appropriate training
  • Have experience in the use of PC’s and Microsoft Office software applications

Additional Qualifications:

  • Prefer experience and familiarity with operations such as cleanroom manufacturing, Swiss machining, milling, stamping, laser cutting, laser welding, coiling, crimping, swaging, adhesive bonding/backfill, liquid silicone & thermoplastic injection molding, annealing, and general mechanical assembly

WORKING ENVIRONMENT

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Technician I, Laser

Summary:

The Technician I, Laser position is responsible for the safe and functional operation of laser cutting and welding equipment. Will be responsible for developing manual or CAD programs required to cut or weld components. Will assist in the development of tooling and fixtures required.

Responsibilities:

  • Provide process training to production operators
  • Perform characterizations, IQ’s, OQ’s, PQ’s, and validations
  • Provide Laser samples when appropriate to support sales effort
  • Provide assistance to Engineering to develop laser quotations and manufacturing procedures
  • Develop CNC programming using a camming software to efficiently meet print requirements
  • Assist Engineering in designing tooling for production
  • Interface with Quality to develop inspection procedures to verify acceptability of components
  • Maintain and promote laser and team safety
  • Evaluate and recommend alternative manufacturing methods
  • Maintain and encourage other to maintain a clean and orderly work area
  • Research and recommend capital equipment for the yearly budget
  • Ensure laser maintenance program is 100% up to date
  • Provides leadership to the team and interrelates well with all areas of the company
  • Effectively resolves all problems that arise or seek assistance in a timely manner
  • Assists the Team Manager in developing highly skilled individuals to be high quality efficient operators
  • Performs duties in a manner to promote good department morale with the team
  • Trains team members and new employee on machines and department procedures
  • Maintains schedules of machines to best meet customer requirements based on meeting daily production schedule as supplied by M2M and Production Control
  • Demonstrates responsibility for department efficiency, quality, pre-production planning, process control, corrective actions, cleanliness and safety
  • Ensures that job BOM’s are accurate and tooling is ordered on timely manner
  • Reliable, consistent and punctual attendance is an essential function of the job
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • 3 Plus years’ experience in the engineering/manufacturing environment for medical devices
  • Recent pulsed laser cutting experience
  • Experience with high tolerance cutting, welding and drilling of metals
  • Set up of laser parameters
  • Experience or a desire to learn CAD/CAM software

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Medical Device Process Engineer

Summary:

The Sr. Engineer, Process Development position is responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities:

  • Attends and arranges project meetings to discuss current and future design and development initiatives
  • May serve as a primary contact with clients on projects of moderate complexity
  • Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner
  • Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Track and communicate project status, plans, issues, timelines, action items, and budgets
  • Provide guidance and direction to coworkers on areas of technical expertise
  • Troubleshoot production processes as required
  • Evaluate and select appropriate test methods for product requirements
  • Responsible for the following project inputs:
    • Feasibility builds, documentation, and testing
    • Equipment selection, process development and documentation
    • Device Verification samples and testing
    • Operator training
    • Process Failure Mode Effects Analysis pFMEA
    • Clinical builds
    • Process Validation
  • Involvement in the full design, development, and validation requirements of projects, including:
    • Product design and specification creation, including mechanical and electrical components, assemblies, and packaging
    • Materials sourcing and device prototyping
    • Design verification and validation activities, including data for regulatory submission,
    • Manufacturing transfer and support of existing product lines as applicable
  • Reliable, consistent and punctual attendance is an essential function of the job
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelors’ degree in an engineering discipline with 5 years of relevant experience; Associates degree in an engineering discipline w/10 years of relevant experience or equivalent.
  • Experience in an engineering/manufacturing environment with a mix of mechanical design, tool design and medical device/component manufacturing process experience.
  • Willingness to travel, if required.
  • Must maintain high ethical standards.
  • Must demonstrate good organizational skills.
  • Ability to train new engineering employees on project engineering activities and Cirtec policies and procedures.
  • Must be able to read, write and speak fluent English.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications, illustrations, and written documents.
  • Strong analytical skills, must be able to obtain and evaluate secondary research information.
  • Ability to learn and apply new technology.
  • Knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics.
  • Tooling/fixturing development.
  • Implantable Pulse Generator IPG and implantable Leads process familiarity.
  • Experience with hermetic seam welding processes and leak detection processes (MIL-STD).
    • Cross sectioning and polishing to measure weld penetration.
    • Aerotek A3200 motion control programming (or similar).
  • Molded components.
    • Feedback on mechanical requirements.
    • Acceptable gate/parting line locations.
    • FM requirements.
    • Working with suppliers of the molded components.
  • Familiarity with ESD requirements, safety precautions; equipment needs; monitoring.
  • Soldering processes; familiarity with IPC-A-610.
  • Machining processes understanding (milling/swiss/stamping) for IPG.
  • Adhesive bonding/curing processes.
  • Evaluate pressure/temp/time inputs for desired cure outputs.
  • Develop processes at temperatures suiting IPG requirements.

WORKING ENVIRONMENT

Work is performed in an office, laboratory and clean room environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Team Lead-Laser

Summary:

This position is primarily responsible to motivate the team to meet production, quality goals, and objectives. Provide complete, timely, and informative communication to all shifts. Ensure that Production Control schedule is followed and contribute to all teams achieving monthly production schedules and quality goals.

Responsibilities:

  • Assesses risks and seeks appropriate assistance from Production Manager/Supervisor
  • Ensures safety guidelines are understood and followed at all times
  • Resolves production problems and documents issues for discussion in meetings with Management, Engineering and Quality
  • Recommends operational changes to Production Manager/Supervisor
  • Gives and receives employee feedback
  • Identifies training and cross-training needs and ensures completion of training records for work cell.
  • Facilitates team participation
  • Review schedule with supervisor and work towards meeting shipment dates-while ensuring quality standards are being maintained.
  • Ensures material transactions are documented and communicated to Production & Inventory Control as needed to support accurate inventory counts
  • Shop cleanliness and tidiness: Work cell is responsible for cleaning the area on a daily basis in accordance with established procedures
  • Will have authority to shut down production for out-of-control situations, contact necessary personnel to solve problems, request additional resources and move resources to other areas for temporary assignments
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English.
  • High school diploma or GED.
  • Minimum 5 years’ experience in a progressive manufacturing environment.
  • Prior experience in a Contract Manufacturing Operation (CMO) is preferred.
  • Relevant experience in leading team performance and regulatory compliance.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Process Development Technician II

Summary:

The Technician II, Process Development is primarily responsible for providing tools and support to engineering and production while adhering to the quality and cost requirements of the company. The tools included but are not limited to written processes and procedures, equipment and fixtures, and training programs. The development of these tools must be based on sound engineering principles and be implemented in accordance with Good Manufacturing processes (GMP) and ISO standards. This position will also support other engineers and areas as needed and performs at an advanced level.

Responsibilities:

  • Identifies, executes and promotes Continuous Improvement objectives
  • Assists in defining Lean Manufacturing requirements
  • Develop processes and procedures for projects to improve quality and cost
  • Originate and maintain written technical descriptions of processes and procedures comprehensive in scope and understandable by the audience
  • Represent engineering for Material Review Board concerning material dispositions
  • Represent Engineering in cross functional teams as assigned
  • Maintain compliance to procedures and regulatory requirements
  • Understand and follow safety policies and practices, attend safety training and wear PPE as required
  • Maintains and prepares project plans to satisfy timeline requirements
  • Prepares Engineering Change Orders for processes and components
  • Performs Corrective and Preventative Action tasks
  • Reliable, consistent and punctual attendance is an essential function of the job
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or G.E.D. Certificate required
  • Two-year technical degree in Engineering preferred
  • 3 Plus years’ experience in the engineering/manufacturing environment for medical devices
  • FDA, cGMP principles and practices, (ISO 9001, ISO 13485)
  • Experience with Silicone molding is a plus
  • Familiarity with Pro-E / CREO and or SolidWorks is preferred.
  • Strong computer skills associated with Microsoft software
  • Ability to interpret technical drawing, blueprints, specification and illustrations
  • Must be able to read, write and speak fluent English
  • Excellent reading, writing, communication, and organizational skills
  • Demonstrated ability for systematic problem solving, DMAIC

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Human Resources Manager

Summary:

This position is responsible for develops policy, directing and coordinating human resources activities, such as: employment, compensation, labor relations, benefits, training, and employee services by performing the following duties.

Responsibilities:

  • Analyzes wage and salary reports and data to determine competitive compensation plan.
  • Writes directives advising department managers of Company policy regarding equal employment opportunities, compensation, and employee benefits.
  • Consults legal counsel to ensure that policies comply with federal and state law.
  • Develops and maintains a human resources system that meets top management information needs.
  • Oversees the analysis, maintenance, and communication of records required by law or local governing bodies, or other departments in the organization.
  • Identifies legal requirements and government reporting regulations affecting human resources functions and ensures policies, procedures, and reporting are in compliance. Studies legislation, arbitration decisions, and collective bargaining contracts to assess industry trends.
  • Writes and delivers presentations to corporate officers or government officials regarding human resources policies and practices.
  • Recruits, interviews, tests, and selects employees to fill vacant positions.
  • Plans and conducts new employee orientation to foster positive attitude toward Company goals.
  • Keeps records of benefits plans participation such as insurance and pension plan, personnel transactions such as hires, promotions, transfers, performance reviews, and terminations, and employee statistics for government reporting.
  • Coordinates management training in interviewing, hiring, terminations, promotions, performance review, safety, and sexual harassment.
  • Advises management in appropriate resolution of employee relations issues.
  • Responds to inquiries regarding policies, procedures, and programs.
  • Administers performance review program to ensure effectiveness, compliance, and equity within organization. Administers salary administration program to ensure compliance and equity within organization.
  • Administers benefits programs such as life, health, and dental insurance, pension plans, vacation, sick leave, leave of absence, and employee assistance.
  • Investigates accidents and prepares reports for insurance carrier. Coordinates Safety Committee meetings and acts as Safety Director.
  • Conducts wage surveys within labor market to determine competitive wage rate.
  • Prepares budget of human resources operations.
  • Prepares employee separation notices and related documentation, and conducts exit interviews to determine reasons behind separations.
  • Prepares reports and recommends procedures to reduce absenteeism and turnover.
  • Represents organization at personnel-related hearings and investigations.
  • Contracts with outside suppliers to provide employee services, such as temporary employees, search firms, or relocation services.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor’s degree.
  • 7-10 years’ prior human resources management experience.
  • Ability to read, analyze, and interpret the most complex documents.
  • Capability to respond effectively to the most sensitive inquiries or complaints.
  • Ability to write speeches and articles using original or innovative techniques or style.
  • Capacity to make effective and persuasive speeches and presentations on controversial or complex topics to top management.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Technician I, Engineering

Summary:

This position is primarily responsible for utilizing state of the art equipment for the development of life changing medical devices. The ideal candidate will be comfortable operating a variety of equipment including, but not limited to; lasers, injection molders, reflow machines as well as an array of test equipment while adhering to the quality requirements of the company. In addition, this position will work with the design and process teams to ideate, create, and build first prototypes. This individual is essential in the maturation of these prototypes and their progress through the development. Lastly, the technician must feel comfortable providing candid feedback to the development team to ensure success in later phases of the program.

Responsibilities:

  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Complies with company, quality and safety standards, policies and procedures.
  • Run equipment tests, collect data and analyze data with the engineering team.
  • Make recommendations on how to improve the quality or efficiency of a process based on data and observation.
  • Ability to diagnose and solve problems with jobs in a timely manner.
  • Assist in training employees on equipment and assembly skills.
  • Interact effectively and assist engineering in improving quality and solving problems.
  • Develop processes and procedures for projects to improve quality and cost.
  • Originate and maintain written technical descriptions of processes and procedures comprehensive in scope and understandable by the audience.
  • Represent engineering for Material Review Board concerning material dispositions.
  • Represent Engineering in cross functional teams as assigned.
  • Maintain compliance to procedures and regulatory requirements.
  • Understand and follow safety policies and practices, attend safety training and wear PPE as required.
  • Prepares Engineering Change Orders for processes and components.
  • Performs Corrective and Preventative Action tasks.
  • Complies with company, quality and safety standards, policies, and procedures
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or G.E.D. Certificate required
  • Two-year technical degree in Engineering preferred
  • Strong drive to learn, share and teach
  • Understanding of and experience with mechanical equipment
  • FDA, cGMP principles and practices, (ISO 9001, ISO 13485)
  • 3 Plus years’ experience in the engineering/manufacturing environment for medical devices
  • In-depth understanding of one or more manufacturing processes is a plus
  • Familiarity with Pro-E / CREO and or SolidWorks is preferred.
  • Strong computer skills associated with Microsoft software
  • Ability to interpret technical drawing, blueprints, specification and illustrations
  • Must be able to read, write and speak fluent English
  • Excellent reading, writing, communication, and organizational skills.
  • Maintains performance with changing priorities under minimal supervision
  • Possess strong team collaboration skills
  • Must be able to make clear and accurate decisions
  • Strong desire to learn and apply new technology

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Brooklyn Park, MN – NovelCath

R&D Engineer I

Summary:

Develops building processes with design for manufacturability in mind and testing protocols for prototypes. Works with engineers, technicians, and operators to keep projects on schedule.

The engineer works with the internal team and customers regarding ideas, drawings, development of designs, to resolve problems and to provide prototypes.

Responsibilities:

  • Support development products relating to defined customer needs or as possible proprietary items. This also may include the adaptation of existing designs to new-customer applications.  These designs may be in the form of freehand sketches or final detail drawings, depending on timing and available drafting time.
  • Construction of prototypes and development builds to meet customer and internal requirements.
  • Testing of new-product prototypes to verify product reliability.
  • Recording process steps and parameters.

ADDITIONAL RESPONSIBILITIES: 

  • Assists production in regard to product or process redesign to resolve production difficulties.
  • Performs other duties when required or requested.
  • An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor’s degree in engineering with one (1) year on-the-job experience.
  • Solidworks experience helpful.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Applications Engineer

Summary:

The Applications Engineer is primarily responsible for building cost models and generating proposals for catheter development and catheter production projects that utilize extrusion, heat-shrink, braiding, coiling, tipping and balloons.  It may also include value-added sub-assemblies and full-device assembly. The Applications Engineer will initially support our Brooklyn Park site and will grow to support our Santa Clara, CA operations.  This position will also be required to assist other Applications Engineering staff with the collection and organization of cost data for complex development and production proposals.

This is a collaborative position that will work very closely with the technical NovelCath team to quickly and efficiently complete proposals and identify the required criteria to win programs.

This individual will work closely with Business Development, Engineering, Supply Chain, Operations and Finance to drive our response time and increase the number of proposals delivered to potential customers.  The role also includes proactively targeting segment revenue and profitability objectives while working to improve the overall quoting process, product cost models and sales reporting tools.

Responsibilities:

  • Collaborate with cross-functional engineering teams to assess and document technical development plans, incorporating knowledge of catheter development and catheter assembly.
  • Applies engineering skills and know-how to evaluate and recommend technical solutions to customer development requests in collaboration with site R&D engineering leadership.
  • Participates in definition of requirements, scope, timeline, and budget for new development programs. Supports others in the development of budgetary project plans, development proposals, and quotations for both new and existing customers.
  • Writes proposals for development and production programs with clear technical communication skills while utilizing a variety of visual and written techniques (e.g. graphs, diagrams, long-form writing).
  • Gather peer review on written proposals and participate in management reviews of the proposals to get required approvals.
  • Monitor customer portfolio revenue and profitability to ensure we are meeting organizational objectives. Develop and present pricing strategies accordingly.
  • Participate in continuous improvement of NovelCath’s design control procedures and internal business processes.
  • Assist with suppliers for sourcing and development of new components.
  • Analyze internal manufacturing and supply chain data to assess actual costs and estimate future production costs.
  • Reliable, consistent and punctual attendance is an essential function of the position.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BS in Biomedical / Mechanical / Finance / Computer engineering discipline with at least 3 years of experience within the medical device industry is preferred.
  • Beneficial to have experience working on medical device development projects from design through transfer to production.
  • 3+ years’ experience in the engineering / manufacturing environment of medical device component assembly.
  • Experience with catheters or delivery systems preferred.
  • Able to work collaboratively within a multi-disciplined team to achieve a common objective.
  • Must be able to interpret technical drawings, product requirements, design specifications and relevant technical documents.
  • Must have proficiency in MS Office software.
  • Must possess excellent written and oral communication skills in English.
  • Willingness to travel, if required.

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Assembler - Cleanroom

Summary:

This position is primarily responsible for assembling a range of components into finished goods across one or more production lines ensuring standard documentation, quality, and production rates are met. Works under the direction of the Production Team Leader/Supervisor.

Responsibilities:

  • Complies with company, quality and safety standards, policies, and procedures.
  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Has the responsibility of following established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from upper-level operators assigned to that cell.
  • Will be proficient in the task of loading components into product specific tools.
  • Primary function of assisting production operators and technicians engaged in processing and product fabrication.
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • May perform weld operations.
  • Must accurately document all work performed on inspection reports and customer travelers.
  • Assists in packaging of finished goods as needed.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Control Inspector

Summary:

This position is primarily responsible for performing receiving, first piece, in-process and final inspection or test on a wide variety of parts and document results. Indicate inspection status, maintain product traceability and non-conforming material control. Participate in internal audits, statistical process control and assist control of process documentation, records, and equipment calibration.

Responsibilities:

  • Inspect, measure and/or test incoming parts, production first piece, in-process and final product, record results and notify appropriate personnel.
  • Indicate inspection status of parts with assigned labels and stamps.
  • Maintain product identification and traceability.
  • Control non-conforming product in accordance with documented procedures and verify timely corrective and preventative action.
  • Protect product during handling and storage in the performance of work.
  • Monitor factory environmental conditions, record data and alert adverse conditions.
  • Assist with distribution and control of process documentation and quality records.
  • Assist with control of measuring and test equipment calibration.
  • Participate in internal quality audits to verify compliance with documented procedures and specifications, record results and verify audit corrective action.
  • Assist with statistical methods of verifying and controlling process capability.
  • Provide input when required to quality planning for specific projects and products.
  • Provide leadership to production personnel on quality issues.
  • Comply with and reinforce the requirements of the Cirtec Quality System Manual and Standard Operating Procedures, ISO 9002, FDA Quality System Regulations, and other customer standards.
  • Follow Occupational Safety and Health regulations, including laser safety practices.
  • Other agreed duties within the Quality Department consistent with training, qualification, and experience.
  • Provide Quality Support for the disposition of discrepant material.
  • Provide leadership to production personnel in relation to quality.
  • Provide Quality Control support to Manufacturing & Engineering.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English
  • High school diploma or GED
  • 3-5 years’ minimum experience in manufacturing, preferably medical devices, with increasing responsibility or a minimum of 5 years’ experience in a manufacturing environment.
  • Certificate/s of training related to this field of work (medical or quality assurance)
  • 3 years’ experience as a Quality Control Inspector
  • Proven experience in inspection and documenting results
  • Able to demonstrate competence in interpreting technical drawings & specifications
  • Proficient in the use of microscopes, measuring and test equipment
  • Able to check dimensions, squareness, hole locations, surface relationships, finish material defects and mechanical strength of product following appropriate training
  • Have experience in the use of PC’s and Microsoft Office software applications

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Chandler, AZ

IC Design Engineer

Summary

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development, and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably, and cost-effectively.

The IC Design Engineer is based out of our Chandler, AZ office. The ideal candidate should have a competent understanding of analog and digital integrated circuit (IC) building blocks through course work or some industry experience.  This position requires the ability to demonstrate exceptional problem-solving skills especially as it relates to circuit design.  The candidate must also understand the basics of semiconductor devices physics, IC layout and characterization of circuit in electronics laboratories.  This individual should be a self-starter and demonstrate the desire and ability to learn new concepts quickly and apply them.

Responsibilities:

  • Transistor level circuit design
  • Simulation test bench development
  • Perform Top level mixed mode simulations as directed
  • Ability to conduct detailed design reviews
  • Implement post silicon evaluation plan as directed
  • Complete bench evaluation and debug of silicon as directed
  • Contribute to the support of production test development
  • Support ASIC qualification hardware and software development Interface with end customer
  • Understand and implement circuits for Implantable medical ASIC
  • Complete designs in Low power design, Power management, Data converters, and Energy harvesting
  • Complies with company, quality and safety standards, policies, and procedures
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BSEE Degree or higher
  • Minimum of 1+ year of experience in integrated circuit design related work or a master’s degree
  • Strong understanding of IC related software tools such as Cadence and Mentor tool sets
  • Strong Written and oral technical communications skills
  • Ability to use MATLAB and LABVIEW are a plus
  • Ability to do PCB level design and the associated tools is a plus
  • Experience characterizing circuit with standard electronics laboratory equipment

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Principal IC Design Engineer

Summary

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development, and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably, and cost-effectively.

The Principal IC Design Engineer is based out of our Chandler, AZ office. The ideal candidate should be able to architect new innovative circuits to solve electronic system challenges. This position will require a person capable of leading IC development projects which would include directing and mentoring other designers, mapping out schedules, resources, and partitioning the design work. Candidate should be able to quickly analyze product proposals and be able to identify critical and challenging design requirements.   The candidate must also understand the basics of semiconductor devices physics, have strong circuit analysis skills, understand good IC layout practices, and implement or guide the characterization of circuits in electronics laboratories.

Responsibilities:

  • Lead design and development of medical ASICs, including transistor level circuit design
  • Develop product specifications and convert to design specifications
  • Develop simulation test bench and other test environments
  • Perform top level mixed mode simulations as directed
  • Act as the Technical Lead on IC design programs, conduct design reviews, and interface with internal stakeholders and customers to communicate technical updates and program status
  • Lead innovatitve designs for low power design, power management, data converters, and energy harvesting
  • Develop a post silicon evaluation plan, support bench evaluation and debug of silicon, and support development of production tests
  • Assist with project management, schedule tracking and allocation of technical resources
  • Assist business development in generating proposals, analyze product proposals and identify critical parameters for implementation
  • Direct and mentor other design engineers
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum BS in Electrical Engineering. Higher degrees preferred.
  • Minimum 10 years of experience in analog and mixed-signal integrated circuit design
  • Experience with leading IC design teams and design of large building blocks of ICs
  • Good understanding of semiconductor manufacturing, packaging, and testing
  • Travel Requirements: Possible need to travel to local or out of state customer or vendor sites

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk, and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  Long hours at the computer is often required.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT

Work is performed in an office/manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. IC Design Engineer (Digital)

Summary

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development, and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably, and cost-effectively.

The Senior IC Design Engineer is based out of our Chandler, AZ office. The ideal candidate should be able to architect new innovative circuits to solve electronic system challenges. This position will require a person capable of leading IC development projects which would include directing and mentoring other designers, mapping out schedules, resources, and partitioning the design work. Candidate should be able to quickly analyze product proposals and be able to identify critical and challenging design requirements.  The candidate must also understand the basics of semiconductor devices physics, have strong circuit analysis skills, understand good IC layout practices, and implement or guide the characterization of circuits in electronics laboratories.

Responsibilities:

  • Lead design and development of medical ASICs, including transistor level circuit design
  • Develop product specifications and convert to design specifications
  • Develop simulation test bench and other test environments
  • Perform top level mixed mode simulations as directed
  • Act as the Technical Lead on IC design programs, conduct design reviews, and interface with internal stakeholders and customers to communicate technical updates and program status
  • Lead innovate designs for low power design, power management, data converters, and energy harvesting
  • Develop a post silicon evaluation plan, support bench evaluation and debug of silicon, and support development of production tests
  • Assist with project management, schedule tracking and allocation of technical resources
  • Assist business development in generating proposals, analyze product proposals and identify critical parameters for implementation
  • Direct and mentor other design engineers
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

  • BSEE Degree or higher
  • Minimum 5 years of experience in digital integrated circuit design
  • Experience with leading IC design teams and design of large building blocks of ICs
  • Good understanding of semiconductor manufacturing, packaging, and testing
  • Travel Requirements: Possible need to travel to local or out of state customer or vendor sites

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. IC Design Engineer (Analog)

Summary

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development, and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably, and cost-effectively.

The Senior IC Design Engineer is based out of our Chandler, AZ office. The ideal candidate should be able to architect new innovative circuits to solve electronic system challenges. This position will require a person capable of leading IC development projects which would include directing and mentoring other designers, mapping out schedules, resources, and partitioning the design work. Candidate should be able to quickly analyze product proposals and be able to identify critical and challenging design requirements.  The candidate must also understand the basics of semiconductor devices physics, have strong circuit analysis skills, understand good IC layout practices, and implement or guide the characterization of circuits in electronics laboratories.

Responsibilities:

  • Lead design and development of medical ASICs, including transistor level circuit design
  • Develop product specifications and convert to design specifications
  • Develop simulation test bench and other test environments
  • Perform top level mixed mode simulations as directed
  • Act as the Technical Lead on IC design programs, conduct design reviews, and interface with internal stakeholders and customers to communicate technical updates and program status
  • Lead innovate designs for low power design, power management, data converters, and energy harvesting
  • Develop a post silicon evaluation plan, support bench evaluation and debug of silicon, and support development of production tests
  • Assist with project management, schedule tracking and allocation of technical resources
  • Assist business development in generating proposals, analyze product proposals and identify critical parameters for implementation
  • Direct and mentor other design engineers
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BSEE Degree or higher
  • Minimum 5 years of experience in analog and mixed-signal integrated circuit design
  • Experience with leading IC design teams and design of large building blocks of ICs
  • Good understanding of semiconductor manufacturing, packaging, and testing
  • Travel Requirements: Possible need to travel to local or out of state customer or vendor sites

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. Manager, IC Development

Summary

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably and cost-effectively.

Based out of our division in Chandler, AZ, the Senior Design Manager will be mainly responsible for leading ASIC development teams through all phases of product development for low power portable devices including Class II and Class III medical ASICs.

Responsibilities:

  • Manage cross-functional ASIC development projects targeted for medical, sensing, and power management applications.
  • Work closely with Program Management to provide the necessary resources and development tools to successfully bring products to market on-time, on-schedule and to specification.
  • Provide technical guidance to design, product and test engineering teams and participate in design reviews.
  • Proactively identify projects risks and issues, and guide engineering teams to formulate and implement risk mitigations and corrective/preventive actions.
  • Collaborate with Program Managers to create and manage development plans related to ASIC development.
  • Work closely with design team members and vendors to evaluate, recommend and setup CAD tools, lab equipment and technologies to bring products to market efficiently and successfully.
  • Manage internal resources to meet goals and milestones on development programs, and identify additional resource needs to support business growth.
  • Support Business Development team to engage new customers and maintain existing customer relationships.
  • Support Business Development and Applications Engineering teams with definition of program scope, timeline, and budget to support preparation of quotations and change orders for customers.
  • Leads continuous improvement of company’s ASIC design capabilities and technologies based on emerging industry trends.
  • Provide career guidance, feedback, mentoring and support to the ASIC Design Team consisting of Analog, Digital and Mask designers.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BS in Electrical or Computer Engineering or in an equivalent engineering discipline. Advanced degrees preferred.
  • 5+ years’ experience as an ASIC Design Engineer.
  • 5+ years’ experience as a Technical Design Lead or IC Design Manager.
  • Experience with development of low power battery operated ASICs preferred.
  • Experience in analog design preferred.
  • Solid understanding of the ASIC Design flow from specification development to production release.
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Enfield, CT

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Technician, Manufacturing

Summary:

This position is primarily responsible for creating and revising technical documents, and investigations associated with Manufacturing Process Instructions (MPI’s), non-conforming product or materials (NCR’s).  This position is expected to work with and assist manufacturing engineers and quality engineers in resolving issues in manufacturing.  It is also expected that in this position there will continue to build their skills by undertaking tasks and direction from the engineering departments.

Responsibilities:

  • Complies with all Good Manufacturing Practices (CGMP) requirements to ensure products are controlled according to the Quality System.
  • Writes and edits technical documents including reference manuals and product manuals.
  • Translates customers technical specifications into work instructions for the direct labor staff that will enable them to follow with little to no training.
  • Writes and edits procedural documentation such as user guides and manuals.
  • Dispositions Non-Conformance Reports (NCR’s) and routes Engineering Change Request (ECN’s).
  • Works with engineers, programmers, and project managers to ensure safe reliable delivery of final product to the customer.
  • Research new processes and equipment that improves line efficiency.
  • Meets internal and external customer deadlines.
  • Gathers feedback from customers, designers, and manufacturers to improve technical documents.
  • Works with Engineering, customer representatives and manufacturing personnel in problem solving exercises.
  • Works with Maintenance personnel and incorporate key critical activities in our standard operating procedures & Work instructions.
  • Working knowledge of drawings with ability to interpret nomenclature and dimensions.
  • Operates effectively and maintains professionalism in an environment of deadlines and high workloads and adjusts schedule or work hours to meet changes in priorities.
  • Assists with processes and documentation for new or modified products.
  • Acts as a resource during audits or customer visits for questions and answers or practical demonstrations.
  • Perform the above duties with little or no supervision.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Excellent verbal and written communication skills.
  • Excellent organizational skills and attention to detail.
  • Ability to present complex data in clear, concise text.
  • Ability to meet deadlines and to work independently.
  • Ability to edit and proofread work of colleagues.
  • Proficient with Microsoft Office Suite or related software.
  • Must be able to read, write and speak fluent English.
  • Associate degree or equivalent experience in medical device industry a plus.
  • Basic understanding of Lean Concepts.
  • Green Belt or Black Belt a plus.
  • Understanding of GT&D.
  • Analytical skills and must have the ability to obtain secondary research information from the Internet or alternate sources.
  • Ability to learn and apply new technology.
  • Knowledge of ERP/MRP business functions.
  • Technical report preparation experience and good verbal communication skills.
  • Able to prioritize and manage multiple responsibilities.

WORKING ENVIRONMENT

Work is performed in manufacturing and office environments.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Operator Assembler II

Summary:

This position is primarily responsible for operating workstations and associated systems used in the manufacturing of products sold to our customers. This position is expected to work with lower-level Operators along with higher level Technicians to effectively meet or exceed expectations for product quality and production rates. In this position they must have a basic knowledge of how to set up and operate workstations, perform visual and dimensional inspections needed to manufacture the products at Cirtec.

Responsibilities:

  • Complies with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Follows established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from upper-level operators assigned to that cell.
  • Proficient in the task of loading components into product specific tools.
  • Primary function, processing, and product fabrication.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • Performs basic workstation set up and troubleshooting tasks.
  • Performs various dimensional inspection using specific gauges, dimensional inspection systems, verniers and micrometers.
  • May perform weld operations.
  • Operates a variety of wafer fab equipment in a production environment.
  • Manually manipulates fragile wafers on a regular basis.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • Adjusts machines as instructed,  to achieve conformance with specifications and maximum yield.
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions.
  • Provides direction within the manufacturing cell to associates assigned to assist them.
  • Assists Quality Control with inspection duties as required.
  • Recognizes quality issues and communicates these issues to Quality and/or Supervisor.
  • Accurately documents all work performed on inspection reports and customer travelers.
  • Assists in packaging of finished goods as needed.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or General Education Degree (GED) is required.
  • 3-5 years’ experience in medical device industry, preferred but not required.
  • Be able to read, write and speak fluent English.
  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail.
  • Meets all requirements of Operator/Assembler I.
  • Knowledge of how to set up and operate workstations.
  • Ability to provide information to engineers for determining root cause in order to identify the appropriate corrective actions.
  • Knowledge of performing visual and dimensional inspections.
  • Strong interpersonal skills to establish and maintain cooperative and effective working relationships.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Operator Assembler I

Summary:

This position is primarily responsible for assembling a range of components into finished goods across one or more production lines ensuring standard documentation, quality, and production rates are met. Works under the direction of the Production Team Leader/Supervisor.

Responsibilities:

  • Complies with company, quality and safety standards, policies, and procedures.
  • Complies with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Follows established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from upper-level operators assigned to that cell.
  • Proficient in the task of loading components into product specific tools.
  • Assists production operators and technicians engaged in processing and product fabrication.
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • Adjusts machines as instructed to achieve conformance with specifications and maximum yield.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • May perform weld operations.
  • Accurately documents all work performed on inspection reports and customer travelers.
  • Assists in packaging of finished goods as needed.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or General Education Degree (GED) is required.
  • 1 year experience in a manufacturing environment preferred but not required.
  • Must be able to read, write and speak fluent English.
  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail.
  • Knowledge of ISO & FDA requirements a plus.
  • Experience with LEAN manufacturing a plus.
  • Ability to work in environment subject to fluctuations in heat, humidity, fumes, odors, dust, and noise.
  • Ability to provide detailed information to assist sustaining engineering in determining root cause in order to identify the appropriate corrective action.
  • Good interpersonal skills to establish and maintain cooperative and effective working relationships.
  • Good written and verbal communication skills.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Inspector I

Summary:

This position is primarily responsible for performing receiving, first piece, in-process and final inspection or test on a wide variety of parts and document results. Indicate inspection status, maintain product traceability and non-conforming material control. Participate in internal audits, statistical process control and assist control of process documentation, records and equipment calibration.

Responsibilities:

  • Inspects, measures and/or tests incoming parts, accessories, assemblies, production first piece, in-process, and final product for conformance to specifications, record results and notify appropriate personnel.
  • Uses drop indicators, calipers, micrometers, profilometers, multimeters, pin gages, thread gages, thread rings, and other measurement and evaluation-capable equipment for the purposes of assessing conformity to specifications.
  • Accurately documents and clearly records the results of inspections and testing.
  • Indicates inspection status of parts with assigned labels and stamps.
  • Maintains product identification and traceability.
  • Controls non-conforming product in accordance with documented procedures and verify timely corrective and preventative action.
  • Presents and/or communicates the status of materials at any time to the Supervisor/Manager.
  • Communicates the status of materials to engineering.
  • Protects product during handling and storage in the performance of work.
  • Monitors factory environmental conditions, records data and alerts adverse conditions.
  • Assists with distribution and control of process documentation and quality records.
  • Assists with control of measuring and test equipment calibration.
  • Participates in internal quality audits to verify compliance with documented procedures and specifications, records results and verifies audit corrective action.
  • Assists with statistical methods of verifying and controlling process capability.
  • Provides input when required to quality planning for specific projects and products.
  • Provides leadership to production personnel on quality issues.
  • Complies with and reinforces the requirements of the Cirtec Quality System Manual and Standard Operating Procedures, ISO 13485, FDA Quality System Regulations, and other customer standards.
  • Follow Occupational Safety and Health regulations, including laser safety practices.
  • Other agreed duties within the Quality Department consistent with training, qualification, and experience.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Program Manager

Summary:

The Sr. Program Manager is mainly responsible for leading and managing development and manufacturing transfer of complex Class II and III medical devices.

Responsibilities:

  • Leads and manages development and manufacturing transfer of complex Class II and III medical devices including active implants, implantable leads, surgical devices and external use devices.
  • Generates and maintains detailed project plans, task lists and project risk registers that enable the team to execute activities based on well-defined prioritization.
  • Manages cross-functional team assigned to the functional segment to ensure successful completion of program goals and milestones, and adequate utilization of resources.
  • Tracks program health in terms of schedule, budget, and technical risks and issues. Prepares and presents comprehensive project status reports to internal and external stakeholders.
  • Proactively anticipates program risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions.
  • Creates and maintains Design History File per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements.
  • Supports project team in establishing and maintaining product requirements and test plans.
  • Contributes to development, quality and risk management activities, and acts as backup to engineers and technical staff on assigned programs as required.
  • Serves as the principal contact with external customers. Coordinates and directs customer meetings and visits, and day-to-day customer communication.
  • Manages internal resources to meet program goals and milestones. Works with internal management to ensure appropriate resources have been assigned.
  • Assists business development team with definition of program scope, timeline, and budget to support preparation of proposals, quotations, and change orders for customers.
  • Manages, mentors and provides guidance to other program manager(s) in the functional group.
  • Reliable, consistent and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum BS in Biomedical / Mechanical / Electronics / Computer Engineering with at least 10 years of experience within the medical device industry.
  • Minimum 5 years of experience in project / program management of medical device development.
  • Experience with neuromodulation devices, active implant devices and/or implantable lead assemblies highly preferred.
  • Demonstrated ability to lead medical device development programs from early stage design through verification/validation, and transfer to production.
  • Must possess strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control.
  • Must be able to interpret technical drawings, product requirements, design specifications and relevant technical documents.
  • Ability to condense and communicate complex technical ideas, project status and risks to internal and external stakeholders.
  • Must have proficiency in MS Project and other MS Office software.
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate.  The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Program Manager

Summary:

The Program Manager is primarily responsible for managing and coordinating development and manufacturing transfer of complex medical devices.

Responsibilities:

  • Manages and coordinates development and manufacturing transfer of complex components, sub-assemblies and finished medical devices.
  • Generates and maintains detailed project plans, task lists and project risk registers that enable the team to execute activities based on well-defined prioritization.
  • Coordinates activities across different functional groups to ensure successful completion of program goals and milestones.
  • Tracks program health in terms of schedule, budget, and technical risks and issues. Prepares and presents comprehensive project status reports to internal and external stakeholders
  • Proactively anticipates program risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions
  • Creates and maintains Design History file per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements
  • Supports project team in establishing and maintaining product requirements and test plans
  • Contributes to development, quality and risk management activities, and acts as backup to engineers and technical staff on assigned programs as required
  • Serves as the principal contact with external customers. Coordinates and directs customer meetings and visits, and day-to-day customer communication.
  • Manages internal resources to meet program goals and milestones. Works with internal management to ensure appropriate resources have been assigned.
  • Assists business development team with definition of program scope, timeline, and budget to support preparation of proposals, quotations, and change orders for customers
  • Reliable, consistent and punctual attendance is an essential function of the job
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum BS in a relevant engineering discipline with at least 5 years of experience within the medical device industry
  • Minimum 2 years of experience in project / program management of medical device development
  • Experience with metals processing and Nitinol-based devices preferred but not required
  • Demonstrated ability to lead medical device development projects from design through verification / validation, and transfer to production
  • Must possess strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control
  • Must be able to interpret technical drawings, product requirements, design specifications and relevant technical documents
  • Ability to condense and communicate complex technical ideas, project status and risks to internal and external stakeholders
  • Must have proficiency in MS Project and other MS Office software
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral
  • Willingness to travel, if required

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate.  The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Los Gatos, CA

Program Manager

Summary:

The Program Manager is primarily responsible for managing and coordinating development and manufacturing transfer of complex medical devices.

Responsibilities:

  • Manages and coordinates development and manufacturing transfer of complex components, sub-assemblies and finished medical devices.
  • Generates and maintains detailed project plans, task lists and project risk registers that enable the team to execute activities based on well-defined prioritization.
  • Coordinates activities across different functional groups to ensure successful completion of program goals and milestones.
  • Tracks program health in terms of schedule, budget, and technical risks and issues. Prepares and presents comprehensive project status reports to internal and external stakeholders.
  • Proactively anticipates program risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions.
  • Creates and maintains Design History file per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements.
  • Supports project team in establishing and maintaining product requirements and test plans
  • Contributes to development, quality and risk management activities, and acts as backup to engineers and technical staff on assigned programs as required.
  • Serves as the principal contact with external customers. Coordinates and directs customer meetings and visits, and day-to-day customer communication.
  • Manages internal resources to meet program goals and milestones. Works with internal management to ensure appropriate resources have been assigned.
  • Assists business development team with definition of program scope, timeline, and budget to support preparation of proposals, quotations, and change orders for customers.
  • Reliable, consistent and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum BS in a relevant engineering discipline with at least 5 years of experience within the medical device industry.
  • Minimum 2 years of experience in project / program management of medical device development.
  • Demonstrated ability to lead medical device development projects from design through verification / validation, and transfer to production.
  • Must possess strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control.
  • Must be able to interpret technical drawings, product requirements, design specifications and relevant technical documents.
  • Ability to condense and communicate complex technical ideas, project status and risks to internal and external stakeholders.
  • Must have proficiency in MS Project and other MS Office software.
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral.
  • Willingness to travel, if required.

WORKING ENVIRONMENT 

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Engineer

Summary:

This position is primarily responsible for monitoring and auditing the quality of all manufactured goods in a medical device industry. Will work to not only find defects, but also to find the cause of the defect and develop a solution. Interact with customers and suppliers in support of engineering projects.

Responsibilities:

  • Provide Quality Engineering support for engineering project development, or sustained manufacturing.
  • Provide Quality Project Management support as needed for product transfers from development to validation.
  • Validation System Owner responsible for the development and management of the validation master plan along with the validation determination.
  • Develop and maintain Validation Standard Operating Procedures.
  • Develop and maintain project Quality Plan for assigned projects.
  • Develop protocols, perform statistical analyses, and write reports for validations and formal process development, which requires quality-engineering involvement such as DOEs.
  • Support the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols to ensure compliance with the Quality System.
  • Provide Quality Engineering support for manufacturing.
  • CAPA (Corrective and Preventative Action) system owner responsible for the support of the corrective action system and procedures.
  • Interact with customers and suppliers to resolve CAPA and complaint investigations and in support of manufacturing.
  • Provide Quality Support for the disposition of material via NCR’s.
  • Provide Quality Project Management Support as needed for product transfers from validation to production.
  • Vendor approval and maintain and assess vendor performance data (i.e. SCAR/on time).
  • Review and document procedure changes for quality requirements and compliance with the quality system.
  • Develop quality systems and procedures as needed.
  • Audit support for third party audits, customer audits and internal audits.
  • Support the implementation of continuous improvement initiatives for production processes.
  • Develop and maintain production quality control plans.
  • Initiate and maintain SPC (Statistical Process Control) for production processes.
  • Provide initiative and support for FMECA (Failure Modes & Effects Criticality Analysis), and DOE (Design of Experiment as applicable.
  • Comply with all work rules including those pertaining to safety, health, quality and Cirtec policies.
  • Back up to Quality Systems Administrator.
  • Perform other duties as necessary.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor of Science or equivalent, preferably in an engineering discipline.
  • Minimum experience in medical/manufacturing environment: 1-2 years
  • Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
  • Must be able to read, write and speak fluent English
  • Must possess excellent verbal communication, organizational and management skills.
  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access.
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.

WORKING ENVIRONMENT 

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality System Specialist

Summary:

Responsible for ensuring operational adherence and compliance to Cirtec Medical’s Quality Management System (QMS) requirements. Ensure compliant execution and coordination of system elements within the Quality Systems & Control functions team.

Responsibilities:

  • Knowledge of identification, traceability, containment, and segregation requirements for handling of NCM.
  • Knowledge of the Materials Review Board (MRB) responsibilities and process for handling of NCM.
  • Knowledge of process(es) for investigation/analysis of returned/complaint materials.
  • Coordinate activities related to NCM, Complaint, RMA, and CAPA processes.
  • Knowledge and experience conducting investigation and root cause analysis of advanced/complex issues.
  • Escalate material nonconformances to CAPA system based on trending and monitoring analysis.
  • Communicate product performance by formal presentations to management committees.
  • Maintain quality system documents related to NCMR, CAPA, and Complaint systems.
  • Consistently abides by and conforms to all established Cirtec Medical policies and procedures.
  • Completes assigned tasks while operating independently and/or with minimal supervision.
  • Responds and adapts to changing priorities with minimal disruption.
  • Act as a CAPA Owner or support CAPA activities, as necessary, driving corrections and corrective actions to successful completion.
  • Provide support to the Supplier Quality management group as needed.
  • Provide support during internal audit and external audits.
  • Ensure adherence to training requirements regarding Quality Management System elements, controls, processes, and procedures.
  • Provide training, as needed, to individuals or groups on NCM Control, CAPA, etc.
  • Support Corporate Quality Management System initiatives and continuous improvement activities.
  • Ensure compliance to regulatory standards and requirements as applicable.
  • Ensure compliance of all site personnel to Corporate and site-level QMS and functional training requirements.
  • Adhere to professional workplace attire, time, attendance and leave of absence policies.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Associated/Bachelor of Science Degree in Manufacturing, Engineering, or Technical Field, or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).
  • Experience examining the data for patterns and trends and working on cross-functional teams.
  • Minimum of 2-4 years of experience in a regulated manufacturing environment required.
  • Advanced Post-Secondary Education/Training/Certification coursework (Manufacturing or Engineering discipline preferred).
  • Quality certification(s) (e.g. ASQ CQT, CQI, etc.)
  • Class I, II and/or III Medical Device manufacturing experience.
  • Other regulated manufacturing industry experience (e.g. Aerospace, Automotive, Defense, Pharmaceutical, etc.)
  • Knowledge of, and experience with, GMP/ISO Standards.
  • Strong verbal and written English language communication skills.
  • Must be knowledgeable of, and adhere to, the Cirtec Medical Quality Management System and its requirements.
  • Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidelines and rules.
  • Must be able to successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements as provided.
  • Must demonstrate ability and/or experience in computer use and general office software – Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Must be able to read, write and speak fluent English.
  • Ability to work with a wide variety of functional areas, including R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Mechanical Engineer I / II

About the Company

More than just another design shop or contract manufacturer, Cirtec offers a uniquely comprehensive range of vertically integrated capabilities. Cirtec specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization.

Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers’ devices to market.  If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you!

Job Summary

As a Mechanical Engineer, you will work on product development teams to bring complex mechanical designs for implants, surgical devices and external electromechanical devices from concept to market.

Responsibilities

  • Applies engineering knowledge and skills as technical engineer for all phases of development projects.
  • Generate and maintain computer-aided drawings (CAD) using Solidworks, schematics and component specifications to document mechanical designs.
  • Participates in hands-on fabrication and testing of prototypes using bench testing, animal and/or cadaver studies to evaluate product designs and recommend and implement design modifications.
  • Perform detailed design reviews and tolerance analyses to achieve product performance, cost, reliability, and manufacturability requirements.
  • Effectively interface with and manage suppliers to fabricate prototype and final components.
  • Develop test plans and protocols and executes prototype testing and design verification testing.
  • Creates medical device manufacturing process instructions, bill of materials, lot history travelers, and related documentation.
  • Contributes towards coordinating and scheduling other staff to work on specific tasks.
  • Communicates directly with clients to understand needs and present results.
  • Effectively interfaces with and manages suppliers to fabricate prototype and final design components.
  • Participates in product risk management and develops and implements risk mitigation strategies.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications

  • Bachelor’s in Mechanical / Biomedical Engineering, or an equivalent engineering discipline.
  • Minimum 0 – 4 years’ experience within the Medical Device industry.
  • Experience in development of medical devices (i.e. delivery tools, catheters, consoles, surgical tools, etc.) is highly preferred.
  • Experience with CAD design using SolidWorks.
  • Excellent communication skills both written and oral.
  • Experience and working knowledge of medical device design control processes highly preferred.

What We Offer

  • A fast-paced work environment
  • Clean, and well-lit production areas
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives, and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a company match

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Working Environment

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO Statement

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Mechanical Engineer

Summary:

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably and cost-effectively.

As a Senior Mechanical Engineer, you will lead a dedicated product development teams to bring complex mechanical designs from concept to market. You will be responsible for the development of novel medical devices including structural heart implants, minimally invasive catheter-based devices and external electromechanical capital equipment.

Responsibilities:

  • Lead product development of complex mechanical and electromechanical medical devices through various phases of concept feasibility, detailed design and verification
  • Lead creation of product requirements and design specifications, and determine applicable regulatory standards and ensures appropriate integration into product requirements
  • Generate and maintain computer-aided drawings (CAD) using Solidworks, schematics and component specifications to document mechanical designs
  • Drive hands-on fabrication and testing of prototypes using bench testing, animal and/or cadaver studies to evaluate product designs, and recommend and implement design modifications
  • Perform detailed design reviews and tolerance analyses to achieve product performance, cost, reliability and manufacturability requirements
  • Serve as the main technical contact with customers and communicate directly with customers to understand project / product needs, and present technical updates, risks and issues
  • Effectively interface with and manage suppliers to fabricate prototype and final components
  • Develop test plans and protocols, and executes prototype testing and design verification testing
  • Lead and contribute towards creation of risk management documentation, including FMEAs
  • Create engineering-level manufacturing process instructions, bill of materials and related manufacturing documentation
  • Proactively anticipate technical risks and issues, and formulate and implement risk mitigations and corrective/preventive actions
  • Assist program managers in developing and maintaining project plans, and in tracking program health in terms of schedule, budget, and technical risks and issues
  • Collaborate with cross-functional team members to create and maintain Design History file per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements
  • Mentor and provide guidance to other engineers and technicians
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BS in Mechanical / Biomedical Engineering with minimum 5 years of experience within the Medical Device industry
  • Experience with product development of structural heart implants and catheter-based devices highly preferred
  • Strong understanding of mechanical component manufacturing (i.e. injection molding, machining, sheet metal fabrication, etc.)
  • Proven experience and proficiency using Solidworks for mechanical design
  • Strong working knowledge and understanding of GD&T and mechanical design standards
  • Excellent communication skills, both written and oral

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Lowell, MA

Production Team Lead - Weekday 1st Shift

Summary:

This position is primarily responsible to motivate the team to meet production, quality goals, and objectives.  Provide complete, timely, and informative communication to all shifts.  Ensure that Production Control schedule is followed and contribute to all teams achieving monthly production schedules and quality goals

Responsibilities:

  • Assesses risks and seeks appropriate assistance from Production Manager/Supervisor
  • Ensures safety guidelines are understood and followed at all times
  • Resolves production problems and documents issues for discussion in meetings with Management, Engineering and Quality
  • Recommends operational changes to Production Manager/Supervisor
  • Gives and receives employee feedback
  • Identifies training and cross-training needs and ensures completion of training records for work cell.
  • Facilitates team participation
  • Ensures material transactions are documented and communicated to Production & Inventory Control as needed to support accurate inventory counts
  • Shop cleanliness and tidiness: Work cell is responsible for cleaning the area on a daily basis in accordance with established procedures
  • Will have authority to shut down production for out-of-control situations, contact necessary personnel to solve problems, request additional resources and move resources to other areas for temporary assignments
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or GED.
  • Minimum 5 years’ experience in a progressive manufacturing environment.
  • Prior experience in a Contract Manufacturing Operation (CMO) is preferred.
  • Relevant experience in leading team performance and regulatory compliance.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Production Team Lead - Weekday 2nd Shift

Summary:

This position is primarily responsible to motivate the team to meet production, quality goals, and objectives.  Provide complete, timely, and informative communication to all shifts.  Ensure that Production Control schedule is followed and contribute to all teams achieving monthly production schedules and quality goals

Responsibilities:

  • Assesses risks and seeks appropriate assistance from Production Manager/Supervisor
  • Ensures safety guidelines are understood and followed at all times
  • Resolves production problems and documents issues for discussion in meetings with Management, Engineering and Quality
  • Recommends operational changes to Production Manager/Supervisor
  • Gives and receives employee feedback
  • Identifies training and cross-training needs and ensures completion of training records for work cell.
  • Facilitates team participation
  • Ensures material transactions are documented and communicated to Production & Inventory Control as needed to support accurate inventory counts
  • Shop cleanliness and tidiness: Work cell is responsible for cleaning the area on a daily basis in accordance with established procedures
  • Will have authority to shut down production for out-of-control situations, contact necessary personnel to solve problems, request additional resources and move resources to other areas for temporary assignments
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or GED.
  • Minimum 5 years’ experience in a progressive manufacturing environment.
  • Prior experience in a Contract Manufacturing Operation (CMO) is preferred.
  • Relevant experience in leading team performance and regulatory compliance.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Document Control Specialist

Summary:

The Document Control Specialist implements and maintains the Engineering Change Notice System. These changes will include product improvements, repairs, and new product development. Coordinates the interaction between engineering, manufacturing, field operations, and marketing to ensure appropriate changes are documented. Provides documentation such as good manufacturing practices (GMP) and good laboratory practices (GLP) procedure manuals and change authorization in accordance with company policies and government regulations.

Responsibilities:

  • Issues part numbers and ECNs and processing documents into the QMS software (i.e. Master Control, Syteline, etc.)
  • Communicates with customer for obtaining ECN approval.
  • Compiles and maintains control records such as release drawings, project documents, quality system documents and manufacturing documents.
  • Makes electronic changes to documents, release documents, and notifies affected departments.
  • Maintains related Document Control files.
  • Ensures documents are filed correctly and maintained per established procedures.
  • Performs database searches, minor data analysis, and reporting to assist Quality Assurance team.
  • Maintains logs and update CAPA, NCMR, Complaint and other Quality Systems files.
  • Prepares reports and memorandums.
  • Ensures Proper upkeep of quality records and documents.
  • Coordinates Training program, which includes facilitating the training and input results into the training QMS system.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • 2-3 years of Document Control experience in the Medical Device Industry required
  • Prior experience with PLM software system, such as Master Control is preferred
  • Strong knowledge in implementing, processing, and maintaining Cirtec and Customers documentation in ERP and PLM Software System
  • Extremely detail-oriented work habits
  • Flexible and motivated attitude
  • Proficient with MS Word, Excel
  • Knowledge of document control procedures with data storage, maintenance, revision and archival background
  • Familiarity with ISO 13485 or other regulatory requirements

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Engineer I, Quality

Summary:

This position is primarily responsible for monitoring and auditing the quality of all manufactured goods in a medical device industry. Will work to not only find defects, but also to find the cause of the defect and develop a solution. Interact with customers and suppliers in support of engineering projects.

Responsibilities:

  • Provide Quality Engineering support for engineering project development, or sustained manufacturing.
  • Provide Quality Project Management support as needed for product transfers from development to validation.
  • Validation System Owner responsible for the development and management of the validation master plan along with the validation determination.
  • Develop and maintain Validation Standard Operating Procedures.
  • Develop and maintain project Quality Plan for assigned projects.
  • Develop protocols, perform statistical analyses, and write reports for validations and formal process development, which requires quality-engineering involvement such as DOEs.
  • Support the development and implementation of IQ (Installation Qualification) and OQ (Operational  Qualification) protocols to ensure compliance with the Quality System.
  • Provide Quality Engineering support for manufacturing.
  • CAPA (Corrective and Preventative Action) system owner responsible for the support of the  corrective action system and procedures.
  • Interact with customers and suppliers to resolve CAPA and complaint investigations and in support of manufacturing.
  • Provide Quality Support for the disposition of material via NCR’s.
  • Provide Quality Project Management Support as needed for product transfers from validation to production.
  • Vendor approval and maintain and assess vendor performance data (i.e. SCAR/on time).
  • Review and document procedure changes for quality requirements and compliance with the quality system.
  • Develop quality systems and procedures as needed.
  • Audit support for third party audits, customer audits and internal audits.
  • Support the implementation of continuous improvement initiatives for production processes.
  • Develop and maintain production quality control plans.
  • Initiate and maintain SPC (Statistical Process Control) for production processes.
  • Provide initiative and support for FMECA (Failure Modes & Effects Criticality Analysis), and DOE  (Design of Experiment as applicable.
  • Comply with all work rules including those pertaining to safety, health, quality and Cirtec policies.
  • Back up to Quality Systems Administrator.
  • Perform other duties as necessary.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor of Science or equivalent, preferably in an engineering discipline.
  • Minimum experience in medical/manufacturing environment: 1-2 years.
  • Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
  • Must possess excellent verbal communication, organizational and management skills.
  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access.
  • Must be able to implement quality programs, interpret the collected data, and present the data to  management to drive continuous improvement.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Technician II, Maintenance

Summary:

This position is primarily responsible for all preventative and corrective maintenance on equipment located in the fab and plating areas.  Maximum emphasis is placed on positive response to the concerns and needs of the company and its environmental health and safety. This is a hands-on position that the equipment maintenance technician works independently and is capable of being successful in a matrix organization.

Responsibilities:

  • Responsible for preventative and corrective maintenance on all fab / plating area tool sets, including component disassembly / assembly / repair.
  • Responsible for identifying needed parts for repairs / preventative maintenance.
  • Perform preventative maintenance as instructed by the Computer Machine Maintenance System (CMMS)
  • Complete work orders in the specified time, directed by the CMMS.
  • Keep work area clean and presentable while performing assigned tasks.
  • Lock/Out Tag Out of equipment when necessary or instructed by Manager.
  • Performing Coolant tank Cleaning.
  • Properly hand and store chemicals and hazardous waste.
  • Maintain written logs of maintenance and repairs in our online system.
  • Ensure that facility maintenance requirements are consistently met.
  • Promptly respond to facilities related issues and ensure effective resolution.
  • Keep apprised of current regulations to effectively address and ensure compliance with ADA (Americans with Disabilities Act), OSHA (Occupational Safety & Health Administration), fire codes requirements, and Material Management for Hazardous Material.
  • Conduct environmental monitoring including particle counts, cleanroom HEPA measurements etc.
  • Direct and coach junior technicians.
  • Triage and submit work order requests.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum 4 – 6 years’ experience in performing preventative and corrective maintenance on semiconductor related equipment.  Similar equipment experience will be considered.
  • Able to troubleshoot electronic circuits to a component level.
  • Proficient with semiconductor processes and cleanroom controls.
  • Familiar with vacuum systems.
  • Must have good computer, written and oral skills.
  • Manual dexterity and visual acuity are required to perform responsibilities.
  • Must be able to read, write and speak fluent English.
  • Must be able to lift 60 lbs.
  • Must be willing to work some weekends, alternating coverage with other maintenance techs.
  • Must be legally authorized to work in the United States.
  • Must be able to work well as a team.
  • Must be willing to work overtime as required.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

CAD Designer

Summary:

This position in primarily responsible for aiding both Engineering and Production teams with CAD design and development support. The CAD Designer will be responsible for the development and approval of drawings with accordance to Cirtec and GD&T standards.  With a focus on the design of 2D and 3D models and prototypes the CAD Designer will produce detailed drawings, assist in quotations, proposal submissions, and documentation for product compliance.

Responsibilities:

  • The Designer will support both Engineering and Production teams with varying degrees of direct project responsibilities while developing a baseline knowledge of sputtering and photolithography processes.
  • Design or redesign complex layouts and drawings from general written or verbal specifications from Manufacturing Engineer(s).
  • Produce fully toleranced (GD&T) CAD drawings for new or improved products using industry, departmental and discipline standards.
  • Work with other teams to obtain reference information for drawings.
  • Work with project team to execute projects on time and on budget.
  • Review design layouts to find and resolve problems involving compatibility with basic design concepts.
  • Work with engineering and manufacturing team to investigate and resolve problems with existing designs.
  • Participate in engineering and manufacturing design reviews to evaluate design concepts and make recommendations.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum 2-year degree in related field (preferred).
  • Bachelor’s or Certifications (preferred).
  • Experience modeling mechanical and/or electrical systems (preferred).
  • 2+ years experience utilizing CAD software such as AutoCad and SolidWorks.
  • Minimum 2 years working in a professional environment.
  • Strong organizational skills.
  • Excellent attention to detail.
  • An abundance of patience to see a complicated project to the end.
  • Ability to work within a multi-discipline team as an individual contributor in a fast-paced changing environment.
  • Ability to work autonomously without supervision required.
  • Comfortable with sitting for long periods of time.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

SMT Technician

Summary:

As an SMT Technician, you will assist with the daily SMT manufacturing operations including process and procedure improvement activities. Utilize SMT machines to place surface mount parts and solder reflow the devices to printed circuit boards. Responsible for the set-up of all pieces of equipment on the SMT line, including the screen printer, the pick and place machines and the reflow oven. Potential for further expansion and growth within the SMT Team.

Responsibilities:

  • Must be familiar with Surface-Mount Technology (SMT) electronic components and SMT assembly process.
  • Able to perform basic soldering and rework of SMT components.
  • Picks components and prepares kits for manufacturing.
  • Able to perform visual inspections of SMT assemblies.
  • Perform machine preventative maintenance on screen printer and pick and place machines based on assigned schedules.
  • Operate stencil cleaning machine.
  • Clean boards as required based on soldering chemistry.
  • Select the proper stencil screens for use during screen printing operation.
  • Attends and project meetings to discuss current and future design and development initiatives.
  • Specifies components, solder, underfill, and cover lay materials use on circuit assemblies.
  • Define and review test requirements to verify circuit performance.
  • Designs and specifies test fixtures in support of circuit performance verification.
  • Specifies metal schemes, base materials and other features as related to circuit performance.
  • Troubleshoots existing designs in support of sustaining manufacturing.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • 2+ years of electronics assembly experience, preferred.
  • Previous experience in a manufacturing environment utilizing automated techniques to install Surface Mount Technology (SMT) and Through-hole Technology (THT) components.
  • Knowledge of ISO 9001 & IPC-A-610 would be helpful.
  • Must know the different package types of electronic components.
  • Ability to function well in a team environment.
  • Demonstrated verbal, interpersonal, and written communication skills, to provide for respectful work-related communications with peers and personnel from other departments.
  • Must be authorized to work in the United States without employer sponsorship.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Supervisor, Production

Summary:

This position is primarily responsible to direct the development and implementation of activities in production area(s) to meet production goals, quality, and cost objectives. Plan, organize and schedule production activities to meet customer demands. Provide direction, leadership and motivation to production personnel, including training and assistance with adhering to the quality system.

Responsibilities:

  • Provides leadership and direction across the associated shift ensuring proper levels of production and quality are met.
  • Ensures conformance to all company policies, procedures and work instructions.
  • Plans, organizes, and schedules production activities (including personnel and equipment) to meet schedules for both standard production and development projects.
  • Maintains production goals and deadlines. Preemptively coordinates material and system requirements to ensure minimum amount of downtime and recommend measures to improve production methods, yields, and the quality of product.
  • Manages production personnel, including planning personnel needs, participating in the hiring process, and managing performance.
  • Conducts daily team meetings for proper communication and development of production team.
  • Develops in depth knowledge of production processes and associated equipment, including laser workstations and CNC motion control programs.  Troubleshoots manufacturing issues as part of maintaining production schedule and developing self-reliance among production technicians.
  • Contributes to development, maintenance, and follow up of production metrics.
  • Plans, implements, and maintains the production environment with focus on safety, cleanliness, and organization.
  • Participates on and leads teams that improve safety, quality, and reliability in the production area, as well as teams that support cost saving and team building initiatives (QDC).
  • Plans and implements technical skills training for production personnel, including generic and product specific skills. Functions as trainer when necessary.
  • Understands the requirements of and ensure compliance with the preventative maintenance program.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English.
  • Associates degree or equivalent experience in a related field.
  • Computer literate (MS Office Suite, Syteline).
  • Understanding and implementation of Lean Manufacturing and Six Sigma for process improvement and problem solving.
  • Strong knowledge of ERP/MRP business functions.
  • Able to prioritize and manage multiple responsibilities.
  • Must be able to read blueprints and interpret technical specifications and illustrations.
  • Experience in technical report writing and verbal communication skills.
  • Minimum 3+ year’s supervisory experience in a manufacturing environment, preferably in a medical device manufacturing environment and in leadership role.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Project Manager

Summary:

The Project Manager position is primarily responsible for managing and coordinating development and manufacturing transfer of complex components and finished medical devices.

Responsibilities:

  • Manages and coordinates development and manufacturing transfer of complex components, sub-assemblies and finished medical devices.
  • Generates and maintains detailed project plans, task lists and project risk registers that enable the team to execute project activities based on well-defined prioritization.
  • Coordinates activities across different functional groups to ensure successful completion of project goals and milestones.
  • Tracks project health in terms of schedule, budget, and technical risks and issues. Prepares and presents comprehensive project status reports to internal and external stakeholders.
  • Proactively anticipates project risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions.
  • Creates and maintains Design History file per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements.
  • Supports project team in establishing and maintaining product requirements and test plans.
  • Serves as the principal contact with external customers. Coordinates and directs customer meetings and visits, and day-to-day customer communication.
  • Manages internal resource allocation to meet program goals and milestones. Works with internal management to ensure appropriate resources have been assigned.
  • Reliable, consistent and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum BS in a relevant engineering discipline with at least 5 years of experience within the medical device industry.
  • Minimum 2 years of experience in project / program management of medical device development.
  • Experience with metals processing and Nitinol-based devices preferred but not required.
  • Must possess strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control.
  • Must be able to interpret technical drawings, product requirements, design specifications and relevant technical documents.
  • Ability to condense and communicate complex technical ideas, project status and risks to internal and external stakeholders.
  • Must have proficiency in MS Project and other MS Office software.
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral.
  • Willingness to travel, if required.

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Engineering Technician

Summary:

The Technician I, Engineering position is primarily responsible for utilizing state of the art equipment for the development of life changing medical devices. The ideal candidate will be comfortable operating a variety of equipment including, but not limited to; lasers, injection molders, reflow machines as well as an array of test equipment while adhering to the quality requirements of the company. In addition, this position will work with the design and process teams to ideate, create, and build first prototypes. This individual is essential in the maturation of these prototypes and their progress through the development. Lastly, the technician must feel comfortable providing candid feedback to the development team to ensure success in later phases of the program.

Responsibilities:

  • Run equipment tests, collect data and analyze data with the engineering team.
  • Make recommendations on how to improve the quality or efficiency of a process based on data and observation.
  • Assist in training employees on equipment and assembly skills.
  • Interact effectively and assist engineering in improving quality and solving problems.
  • Develop processes and procedures for projects to improve quality and cost.
  • Originate and maintain written technical descriptions of processes and procedures comprehensive in scope and understandable by the audience.
  • Represent engineering for Material Review Board concerning material dispositions.
  • Represent Engineering in cross functional teams as assigned.
  • Maintain compliance to procedures and regulatory requirements.
  • Understand and follow safety policies and practices, attend safety training and wear PPE as required.
  • Prepares Engineering Change Orders for processes and components.
  • Performs Corrective and Preventative Action tasks.
  • Reliable, consistent and punctual attendance is an essential function of the job
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • 3-plus years’ experience in the engineering/manufacturing environment for medical devices.
  • Strong drive to learn, share and teach.
  • Understanding of and experience with mechanical equipment.
  • FDA, cGMP principles and practices, (ISO 9001, ISO 13485).
  • In-depth understanding of one or more manufacturing processes is a plus.
  • Familiarity with Pro-E / CREO and or SolidWorks is preferred.
  • Strong computer skills associated with Microsoft software.
  • Ability to interpret technical drawing, blueprints, specification and illustrations.
  • Ability to diagnose and solve problems with jobs in a timely manner.
  • Must be able to read, write and speak fluent English.
  • Excellent reading, writing, communication, and organizational skills.
  • Maintains performance with changing priorities under minimal supervision.
  • Possess strong team collaboration skills.
  • Must be able to make clear and accurate decisions.
  • Strong desire to learn and apply new technology.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Production Team Lead

Summary:

Schedule: Monday through Thursday 5:00am – 3:30pm (WD1 Shift)

This position is primarily responsible to motivate the team to meet production, quality goals, and objectives. Provide complete, timely, and informative communication to all shifts. Ensure that Production Control schedule is followed and contribute to all teams achieving monthly production schedules and quality goals.

Responsibilities:

  • Assesses risks and seeks appropriate assistance from Production Manager/Supervisor.
  • Ensures safety guidelines are understood and followed at all times.
  • Resolves production problems and documents issues for discussion in meetings with Management, Engineering and Quality.
  • Recommends operational changes to Production Manager/Supervisor.
  • Gives and receives employee feedback.
  • Identifies training and cross-training needs and ensures completion of training records for work cell.
  • Facilitates team participation.
  • Review schedule with supervisor and work towards meeting shipment dates-while ensuring quality standards are being maintained.
  • Ensures material transactions are documented and communicated to Production & Inventory Control as needed to support accurate inventory counts.
  • Shop cleanliness and tidiness: Work cell is responsible for cleaning the area on a daily basis in accordance with established procedures.
  • Will have authority to shut down production for out-of-control situations, contact necessary personnel to solve problems, request additional resources and move resources to other areas for temporary assignments.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English.
  • High school diploma or GED.
  • Minimum 5 years’ experience in a progressive manufacturing environment.
  • Prior experience in a Contract Manufacturing Operation (CMO) is preferred.
  • Relevant experience in leading team performance and regulatory compliance.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Engineer II, Process Development

Summary:

The Engineer II, Process Development position is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities:

  • Attends and arranges project meetings to discuss current and future design and development initiatives.
  • May serve as a primary contact with clients on projects of low to moderate complexity.
  • Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
  • Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Have input to project manager for tracking and communicating project status, plans, issues, timelines, action items, and budgets.
  • Responsible for the following project inputs:
    • Feasibility builds, documentation, and testing
    • Equipment selection
    • Process development and documentation
    • Device Verification samples and testing
    • Operator training
    • Process Failure Mode Effects Analysis
    • Clinical builds
    • Process Validation
  • Involvement in the full design, development, and validation requirements of projects, including:
    • Product design and specification creation, including mechanical and electrical components, assemblies, and packaging
    • Materials sourcing and device prototyping
    • Design verification and validation activities, including data for regulatory submission
    • Manufacturing transfer and support of existing product lines, as applicable
  • Reliable, consistent and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • A Bachelor’s degree in an engineering discipline.
  • Willingness to travel, if required.
  • Must maintain high ethical standards.
  • Must demonstrate good organizational skills.
  • Must be able to read, write and speak fluent English.
  • Experience in an engineering/manufacturing environment with mechanical, tool design, and manufacturing processes preferred.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications & illustrations.
  • Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information.
  • Ability to learn and apply new technology.
  • Technical report preparation and formal presentation skills.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Material Coordinator

Summary:

This position is primarily responsible for inventory control, job order material usage reconciliation, job closings, and inventory reconciliation. Coordinating with purchasing and production to ensure the inventory is accurate and appropriate to meet demands.  Perform duties within the production and inventory control department as required.

Responsibilities:

  • Review jobs requiring materials via the ERP system.
  • Issue materials to assigned jobs physically and in ERP system.
  • Return materials from completed jobs physically and in ERP system.
  • Perform monthly cycle count in assigned area(s).
  • Communicate any material shortages to appropriate departments as needed.
  • Prepare outgoing shipments to subcontract suppliers.
  • Close all production jobs, verifying material issues before doing so.
  • Copy all documents necessary for and file into the DHR file.
  • Prepare closed jobs with necessary documentation for AR invoicing.
  • Provide customers with Inventory reports of their material as requested.
  • Create “customer supplied” materials purchase orders.
  • Support customer service with releasing job orders to the floor.
  • Maintain and monitor manual or computerized inventory control system for raw materials and finished stock.
  • Investigate all discrepancies.
  • Perform cycle counts and assist with annual physical inventory as required.
  • Support or provide back-up to Shipping, Production and Inventory Control functions as required.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum five years’ experience in a manufacturing environment, two years of which include operation of an automated inventory control system.
  • Inventory management and control disciplines
  • Computerized inventory record keeping systems4-year degree plus10 years complex assembly manufacturing engineering work experience in a regulated environment.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Maintenance Technician I

Summary:

This position is primarily responsible for all preventative and corrective maintenance on equipment located in the fab and plating areas.  Maximum emphasis is placed on positive response to the concerns and needs of the company and its environmental health and safety. This is a hands-on position that the equipment maintenance technician works independently and is capable of being successful in a matrix organization.

Responsibilities:

  • Responsible for preventative and corrective maintenance on all fab / plating area tool sets, including component disassembly / assembly / repair.
  • Responsible for identifying needed parts for repairs / preventative maintenance.
  • Perform preventative maintenance as instructed by the Computer Machine Maintenance System (CMMS).
  • Complete work orders in the specified time, directed by the CMMS.
  • Keep work area clean and presentable while performing assigned tasks.
  • Lock/Out Tag Out of equipment when necessary or instructed by Manager.
  • Performing Coolant tank Cleaning.
  • Properly hand and store chemicals and hazardous waste.
  • Maintain written logs of maintenance and repairs in our online system.
  • Ensure that facility maintenance requirements are consistently met.
  • Promptly respond to facilities related issues and ensure effective resolution.
  • Keep apprised of current regulations to effectively address and ensure compliance with ADA (Americans with Disabilities Act), OSHA (Occupational Safety & Health Administration), fire codes requirements, and Material Management for Hazardous Material.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum 3 – 5 years’ experience in performing preventative and corrective maintenance on semiconductor related equipment.  Similar equipment experience will be considered.
  • Able to troubleshoot electronic circuits to a component level.
  • Familiar with vacuum systems.
  • Must have good computer, written and oral skills.
  • Manual dexterity and visual acuity are required to perform responsibilities.
  • Must be able to lift 60 lbs.
  • Must be willing to work some weekends, alternating coverage with other maintenance techs.
  • Must be legally authorized to work in the United States.
  • Must be able to work well as a team.
  • Must be able to work overtime are required.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Production Team Lead - Weekend 2nd Shift

Summary:

This position is primarily responsible to motivate the team to meet production, quality goals, and objectives.  Provide complete, timely, and informative communication to all shifts.  Ensure that Production Control schedule is followed and contribute to all teams achieving monthly production schedules and quality goals.

Responsibilities:

  • Assesses risks and seeks appropriate assistance from Production Manager/Supervisor
  • Ensures safety guidelines are understood and followed at all times
  • Resolves production problems and documents issues for discussion in meetings with Management, Engineering and Quality
  • Recommends operational changes to Production Manager/Supervisor
  • Gives and receives employee feedback
  • Identifies training and cross-training needs and ensures completion of training records for work cell.
  • Facilitates team participation
  • Ensures material transactions are documented and communicated to Production & Inventory Control as needed to support accurate inventory counts
  • Shop cleanliness and tidiness: Work cell is responsible for cleaning the area on a daily basis in accordance with established procedures
  • Will have authority to shut down production for out of control situations, contact necessary personnel to solve problems, request additional resources and move resources to other areas for temporary assignments
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or GED.
  • Minimum 5 years’ experience in a progressive manufacturing environment.
  • Prior experience in a Contract Manufacturing Operation (CMO) is preferred.
  • Relevant experience in leading team performance and regulatory compliance.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Technician

Summary:

The position will be responsible for ensuring Cirtec Medical product(s) meet all defined and specified requirements for determination of conformity for Quality Assurance and Control

Responsibilities:

  • Must be knowledgeable of, and adhere to, the Cirtec Medical Quality Management System and its requirements.
  • Must be able to accurately document and record the results of inspections and testing.
  • Must be able to present and/or communicate the status of materials at any time to the Supervisor/Manager.
  • Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidelines and rules.
  • Must maintain an organized and operationally effective work environment.
  • Must adhere to professional workplace attire, time, attendance and leave of absence policies.
  • Other duties and responsibilities as assigned.
  • An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High School Diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
  • Minimum of 1-2 years professional experience.
  • Quality certification(s) (e.g. ASQ CQT, QCI, etc.)
  • Class I, II and/or III Medical Device manufacturing experience.
  • Other regulated manufacturing industry experience (e.g. Aerospace, Automotive, Defense, Pharmaceutical, etc.)
  • Knowledge of, and experience with, GMP/ISO Standards.
  • Strong verbal and written English language communication skills.
  • Must demonstrate ability to perform visual inspections (i.e. detect defects) using a microscope and/or magnification visual inspection system.
  • Must demonstrate ability to read manufacturing prints and identify associated specification/characteristics related to inspection and testing to be performed.
  • Must be able to successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements as provided.
  • Must demonstrate ability and/or experience in computer use and general office software – Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

Cirtec Medical is interested in every qualified candidate who is eligible to work in the United States. However, at this time we are not able to sponsor visas for this particular position.

Cirtec Medical’s immigration sponsorship policy is applied in a nondiscriminatory fashion regardless of race, gender, ethnic origin, or any other classification protected by law. Cirtec Medical is an equal opportunity employer

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Engineer, Process Development

Summary:

The Sr. Engineer, Process Development position is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities:

  • Attends and arranges project meetings to discuss current and future design and development initiatives.
  • May serve as a primary contact with clients on projects of moderate complexity.
  • Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
  • Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Track and communicate project status, plans, issues, timelines, action items, and budgets.
  • Provide guidance and direction to coworkers on areas of technical expertise.
  • Troubleshoot production processes as required.
  • Evaluate and select appropriate test methods for product requirements.
  • Responsible for the following project inputs:
    • Feasibility builds, documentation, and testing
    • Equipment selection, process development and documentation
    • Device Verification samples and testing
    • Operator training
    • Process Failure Mode Effects Analysis
    • Clinical builds
    • Process Validation
  • Involvement in the full design, development, and validation requirements of projects, including:
    • Product design and specification creation, including mechanical and electrical components, assemblies, and packaging
    • Materials sourcing and device prototyping
    • Design verification and validation activities, including data for regulatory submission
    • Manufacturing transfer and support of existing product lines as applicable
  • Reliable, consistent and punctual attendance is an essential function of the job
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • A Bachelor’s degree in an engineering discipline with 5 years of relevant experience; Associates degree in an engineering discipline w/10 years of relevant experience or equivalent.
  • Experience in an engineering/manufacturing environment with a mix of mechanical design, tool design and manufacturing process experience.
  • Willingness to travel, if required.
  • Must maintain high ethical standards.
  • Must demonstrate good organizational skills.
  • Ability to train new engineering employees on project engineering activities and Cirtec policies and procedures.
  • Must be able to read, write and speak fluent English.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications, illustrations, and written documents.
  • Strong analytical skills; must be able to obtain and evaluate secondary research information.
  • Ability to learn and apply new technology.
  • Moderate knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Electrical Engineer II

Summary:

The Electrical Engineer II position is primarily responsible the development of electro-mechanical designs for the creation of medical device products.

Responsibilities:

  • Performs design and analysis to achieve product performance, cost, reliability, manufacturability requirements
  • Performs circuit design including analog input signal conditioning, embedded control, motor control, telemetry, and inductive power coupling
  • Designs battery controlled devices
  • Designs power supplies, battery systems, power management and charging circuits
  • Designs and/or leads design of printed circuit assemblies and electromechanical assemblies
  • Trouble shoots designs and maintains engineering notebook
  • Specifies and/or designs embedded software and firmware for test and verification purposes
  • Develops electronic and electromechanical system requirements (specifications) and development plans
  • Interfaces with and manages suppliers to fabricate prototype and final design components
  • Participates in architecture design, subsystem requirements partitioning, requirements management and configuration management during product development
  • Builds, tests, debugs, and maintains configuration of prototype assemblies
  • Develops and executes formal design verification tests
  • Develops documentation of specifications, designs, test plans and reports for inclusion in medical product Design History Files
  • Creates and releases medical device manufacturing process instructions, bills of material, lot history travelers, and related documentation
  • Participates in the development of quality inspection and manufacturing process instructions for electronic assemblies
  • Reliable, consistent and punctual attendance is an essential function of the job
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum BS/MS in an engineering discipline; with 5+ years’ experience in a product development role.
  • Familiarity and experience with electronic design automation tools: e.g.: schematic capture, analog and digital circuit simulation, tolerance and worst-case analysis, etc.
  • Experienced in at least two of the following areas:
  • Embedded control design
  • Embedded software and firmware design
  • Power supply and battery management circuits
  • Design of Lithium Ion Battery Packs
  • Motor control: stepper, BLDC controls and position sensors
  • Analog and digital sensor interfacing and signal processing
  • Excellent communication skills both written and oral
  • Experience with Altium Designer
  • Experience with Systems and Electronic CAD and simulation tools (e.g.: MATLAB, SPICE, Labview, etc.
  • Printed circuit layout experience
  • FPGA design experience
  • Experience within the Medical Device or a highly regulated industry
  • Knowledge of Medical Device Verification and Validation for compliance with FDA guidance

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Business Services Manager

Summary:

This position is primarily responsible for supporting sales and marketing by driving the sales quoting process. This includes detailed technical analysis and proposal writing to support RFQ and grants applications.  Will work closely with Business Development, Operations and Finance to develop quotes, product pricing models and assist in the construction of overall program timelines.  In addition will be accountable for analyzing sales opportunities and support the approval process.  Will be responsible for developing dashboards and other strategic sales reporting tools.

Responsibilities:

  • Develop and implement quote process for new development and manufacturing opportunities.
  • Develop quote metrics.
  • Oversee all quoting activities, including existing manufacturing repricing to ensure financial objectives are being met.
  • Coordinate all quoting activities for Cirtec’s operations.
  • Develop quote metrics and report to management periodically.
  • Meet with perspective customers to understand needs and develop quote based on inputs.
  • Assist with sales pipeline management.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Technical Bachelor’s Degree, MBA preferred
  • Strong background in Class II and III medical devices (neuromodulation and cardiac assist knowledge a plus).
  • Strong industry involvement a plus.
  • Program Management skills.
  • Microsoft Project and general software skills required (Word, Excel, PowerPoint etc.)
  • Excellent communication skills both written and verbal.
  • Strong financial background.
  • CM Operational experience.
  • Experience building product cost models.
  • Experience quoting design and development activities.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Supervisor, Plating

Summary:

This position is primarily responsible to direct the development and implementation of activities in the plating lab production area(s) to meet production goals, quality, and cost objectives. Plan, organize and schedule production activities to meet customer demands. Provide direction, leadership, and motivation to production personnel, including training and assistance with adhering to the quality system.

Responsibilities:

  • Adhere to all safety and Good Laboratory Practice regulations as well as company policies.
  • Must be able to execute Standard Operating Procedures and be able to keep detailed, organized records and complete the required documentation.
  • Implementing and ensuring adherence to various safety programs.
  • Helping to establish and ensure adherence to standard operating procedures.
  • Working with the broader technical team to develop preventative maintenance schemes for various pieces of equipment.
  • Actively managing our chemical inventory with regard to proper storage, use, upkeep, labeling, and disposal.
  • Monitoring satellite waste sites and managing waste removal with our hazardous waste vendor.
  • Coordinating with third party contractors and vendors to perform various calibration and maintenance activities.
  • Working with facilities to improve lab infrastructure.
  • Establishing and maintaining housekeeping best practices for our lab.
  • Regularly auditing lab facilities for safety, cleanliness, and organization.
  • Maintaining inventory of PPE, hardware, and consumables.
  • Providing technical support on various projects throughout the team
  • Supervise the day-to-day operation of the department to insure smooth flow of production.
  • Oversees the scheduling of staff to ensure production schedules are met.
  • Performs duties in compliance with all applicable regulatory and accredited agencies and cGMP expectations.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English.
  • BS in Chemistry, Biology, medical laboratory science or similar.
  • Minimum 3+ year’s supervisory experience in a manufacturing environment, preferably in a medical device manufacturing environment and in leadership role
  • Computer literate (MS Office Suite, Syteline)
  • Understanding and implementation of Lean Manufacturing and Six Sigma for process improvement and problem solving.
  • Strong knowledge of ERP/MRP business functions.
  • Able to prioritize and manage multiple responsibilities.
  • Knowledge of chemistry principles and methods with the ability to interpret results and an ability to communicate effectively.
  • Experience in technical report writing and verbal communication skills.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Opportunities in San Jose, CA – NovelCath

Operator

Summary:

This position is primarily responsible for operating workstations and associated systems used in the manufacturing of products sold to our customers. This position is expected to work with lower-level Operators along with higher level Technicians to effectively meet or exceed expectations for product quality and production rates. In this position they must have a basic knowledge of how to set up and operate workstations, perform visual and dimensional inspections needed to manufacture the products at Cirtec.

Responsibilities:

  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Has the responsibility of following established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from upper-level operators assigned to that cell.
  • Will be proficient in the task of loading components into product specific tools.
  • Primary function, processing, and product fabrication.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • Performs basic workstation set up and troubleshooting tasks.
  • Performs various dimensional inspection using specific gauges, dimensional inspection systems, verniers and micrometers.
  • May perform weld operations.
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions.
  • Provides direction within the manufacturing cell to associates assigned to assist them.
  • Assists Quality Control with inspection duties as required.
  • Recognizes quality issues and communicates these issues to Quality and/or Supervisor.
  • Must accurately document all work performed on inspection reports and customer travelers.
  • Assists in packaging of finished goods as needed.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or General Education Degree (GED) is required.
  • 3-5 years’ experience in medical device industry, preferred but not required.
  • Be able to read, write and speak fluent English.
  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail.
  • Meets all requirements of Operator/Assembler I.
  • Knowledge of how to set up and operate workstations.
  • Ability to provide information to engineers for determining root cause in order to identify the appropriate corrective actions.
  • Knowledge of performing visual and dimensional inspections.
  • Strong interpersonal skills to establish and maintain cooperative and effective working relationships.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT
Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Technician

Summary:

The Quality Technician is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, and quality systems.

Responsibilities:

  • Complies with company, quality and safety standards, policies, and procedures.
  • Under Quality Engineer (QE) oversight, assist with qualification and validation (IQ, OQ, PQ).
  • Compile and analyze statistical data to assess process capabilities and control processes.
  • Develop inspection test methods and draft inspection procedures with QE oversight.
  • Handle Calibration Management including new and current equipment that requires calibration, calibration supplier management and out of tolerance reporting as required.
  • Handle Environmental Monitoring Management including collecting samples, testing, entering and trending results and out of tolerance reporting as required.
  • Support the nonconforming material reporting process including verifying nonconformance descriptions, evaluating to determine root cause of the nonconformance and proposing final disposition of nonconforming product.
  • Review and approve inspection and device history records as required.
  • Support CAPA process by assisting in the investigation and implementation of corrective action.
  • Identify areas of improvement and participate in continuous improvement projects.
  • Perform Gemba walks and participate in 5S activities.
  • Support QEs and other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

EEO STATEMENT
Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.
Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Senior Quality Engineer

Summary:

This position is primarily responsible for monitoring and auditing the quality of all manufactured goods in a medical device industry. Will work to not only find defects, but also to find the cause of the defect and develop a solution. Interact with customers and suppliers in support of engineering projects.

Responsibilities:

  • Provide Quality Engineering support for engineering project development, or sustained manufacturing.
  • Provide Quality Project Management support as needed for product transfers from development to validation.
  • Validation System Owner responsible for the development and management of the validation master plan along with the validation determination.
  • Develop and maintain Validation Standard Operating Procedures.
  • Develop and maintain project Quality Plan for assigned projects.
  • Develop protocols, perform statistical analyses, and write reports for validations and formal process development, which requires quality-engineering involvement such as DOEs.
  • Support the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols to ensure compliance with the Quality System.
  • Provide Quality Engineering support for manufacturing.
  • CAPA (Corrective and Preventative Action) system owner responsible for the support of the corrective action system and procedures.
  • Interact with customers and suppliers to resolve CAPA and complaint investigations and in support of manufacturing.
  • Provide Quality Support for the disposition of material via NCR’s.
  • Provide Quality Project Management Support as needed for product transfers from validation to production
  • Vendor approval and maintain and assess vendor performance data (i.e. SCAR/on time).
  • Review and document procedure changes for quality requirements and compliance with the quality system.
  • Develop quality systems and procedures as needed.
  • Audit support for third party audits, customer audits and internal audits.
  • Support the implementation of continuous improvement initiatives for production processes.
  • Develop and maintain production quality control plans.
  • Initiate and maintain SPC (Statistical Process Control) for production processes.
  • Provide initiative and support for FMECA (Failure Modes & Effects Criticality Analysis), and DOE (Design of Experiment as applicable.
  • Serves as backup to Quality Systems Administrator.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor of Science, preferably in an engineering discipline.
  • Minimum experience in medical/manufacturing environment: 2-5years (BS) OR 5-6years (AS) OR 7 years (ND).
  • Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
  • Must possess excellent verbal communication, organizational and management skills.
  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access.
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.
  • Must be able to analyze and process information; promote Process Improvement, Developing Standards, Managing Processes, Manufacturing Methods and Procedures; and Supports Innovation.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT
Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.
Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Material Coordinator

Summary:

This position is primarily responsible for inventory control, job order material usage reconciliation, job closings, and inventory reconciliation. Coordinating with purchasing and production to ensure the inventory is accurate and appropriate to meet demands.  Perform duties within the production and inventory control department as required.

Responsibilities:

  • Review jobs requiring materials via the ERP system.
  • Issue materials to assigned jobs physically and in ERP system.
  • Return materials from completed jobs physically and in ERP system.
  • Perform monthly cycle count in assigned area(s).
  • Communicate any material shortages to appropriate departments as needed.
  • Prepare outgoing shipments to subcontract suppliers.
  • Close all production jobs, verifying material issues before doing so.
  • Copy all documents necessary for and file into the DHR file.
  • Prepare closed jobs with necessary documentation for AR invoicing.
  • Provide customers with Inventory reports of their material as requested.
  • Create “customer supplied” materials purchase orders.
  • Support customer service with releasing job orders to the floor.
  • Maintain and monitor manual or computerized inventory control system for raw materials and finished stock.
  • Investigate all discrepancies.
  • Perform cycle counts and assist with annual physical inventory as required.
  • Support or provide back-up to Shipping, Production and Inventory Control functions as required.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum five years’ experience in a manufacturing environment, two years of which include operation of an automated inventory control system.
  • Inventory management and control disciplines
  • Computerized inventory record keeping systems4-year degree plus10 years complex assembly manufacturing engineering work experience in a regulated environment.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

General Referral Application

General Referral

Don’t see a position that fits your background and experience? We are always accepting applications and resumes that we keep on file. If we open a new position that better fits your background and experience we can review your general referral application.

Email CareersAtCirtec@Cirtecmed.com