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. Cirtec has rewarding opportunities where you can make a difference. To view all current positions and apply online, visit the Cirtec Career Site or review the positions below and click Apply Now.


If you value teamwork, client focus, accountability and innovative thinking, Cirtec is the place for you! 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.

Opportunities in Brooklyn Park, MN

Buyer Planner

Summary:

The Buyer Planner creates and owns material plans in support of production needs. The Buyer Planner generates purchase orders and manages supplier deliveries. The Buyer Planner is responsible for the availability and flow of produced and purchased materials.

Responsibilities:

  • Create, maintain, and improve material and production plans and schedules.
  • Plan and execute purchase orders to support production plans and financial goals.
  • Drive improvements in schedule attainment and inventory velocity.
  • Use appropriate tools and concepts such as MRP, safety stock, ERP system data to schedule or purchase items to meet customer demand.
  • Monitor jobs to ensure they will finish on time.
  • Participate in the Engineering Change Notification process.
  • Establish and maintain secure and dependable relationships with internal and external suppliers.
  • Quote and procure components, consumables, services and/or equipment as required. Develop relationships with suppliers and negotiate the best possible lead-times and cost.
  • Monitor metrics such as on time delivery, lead time, and stock-outs.
  • Other 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.

Qualifications:

  • Demonstrated purchasing and supplier management background
  • Experience in planning and scheduling techniques to drive on time delivery to Customers
  • Understanding of ERP/MRP based planning systems and lean manufacturing principles
  • 3 – 5 years relevant manufacturing experience required in medical, pharma and or similarly regulated industries
  • Bachelor’s degree and or APICS/ASCM certification
  • Knowledge of Supply Chain Management concepts and processes
  • Strong interpersonal communication skills including in-person and virtual

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

Sr. Mechanical Designer

Summary:

This position is primarily responsible for developing and designing medical devices, tooling and fixtures. This role will support all PDMWorks Admin duties maintaining a robust PDM system maintaining a user-friendly link between SolidWorks and Oracle PLM. This position must be implemented in accordance with Good Manufacturing Practices, Good Documentation Practices, ISO and FDA requirements.

Responsibilities:

  • Own PDMWorks admin duties, manage/maintain vault, templates, user support across multiple sites
  • Design detailed tooling and fixtures independently and with input from the subject matter expert or engineer
  • Design detailed medical device related engineering drawings independently and with input from the subject matter expert or engineer
  • Generate 3D models and Engineering drawings utilizing SolidWorks
  • Concept design
  • Work independently or with little assistance
  • Multitask
  • Manage workload to support various departments
  • 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
  • Maintain CAD database support in multiuser environment
  • Review ECNs for drawing release and revisions
  • 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 1-year PDMWorks Administrator experience
  • FDA, cGMP, GDP principles and practices, (ISO 9001, ISO 13485)
  • 7 plus years’ experience in the engineering/manufacturing environment (Machining, Finishing, and assembly) for medical devices related to product and tool design
  • Proficiency with Solidworks required
  • 3D printing knowledge
  • Understanding of toolmaking/machining practices
  • Ability to use basic hand and power tools
  • Solid working knowledge of dimensioning and geometric 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 minimal supervision
  • Possess team collaboration skills
  • Must be able to make clear and accurate decisions
  • Strong mechanical aptitude
  • Possess degree of professionalism
  • PLM/PDM file management experience 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/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

Help Desk Agent II

Summary:

This position is primarily responsible for providing day-to-day desktop support to onsite and remote employees.  This is a tiered position that allows for professional growth and increased responsibility.

Responsibilities:

  • Provides timely response to and resolution of IT Help Desk requests and incidents.
  • Installs, configures, and troubleshoots end-user desktops, laptops, and tablets.
  • Installs, troubleshoots, and supports all corporate and commonly used software applications.
  • Maintains Microsoft Active Directory user profiles and group memberships.
  • Performs user access & security configurations for various systems and applications.
  • Participates in and supports select IT infrastructure projects.
  • Supports and helps troubleshoot WAN, LAN & wireless issues.
  • Sets up breakroom equipment for company-wide conference calls.
  • Provides ongoing maintenance for a mixed Microsoft Windows desktop environment.
  • Supports telephone system and all other communication media, including video conferencing.
  • Installs, troubleshoots, and supports the Microsoft O365 application stack.
  • Adheres to existing IT department protocols and governance.
  • Maintains local end-user device inventory and issues Purchase Requests as needed.
  • Communicates with and coordinates local IT vendors and contractors to help supplement IT projects, infrastructure, coverage, and technical support as needed.
  • Performs 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+ years of end-user, desktop, network, and server support (preferably, in a medical device manufacturing environment).
  • College or Technical School Degree or equivalent experience.
  • CompTIA A+ or MCDST (Microsoft Certified Desktop Support Technician) is preferred.
  • Knowledge & experience providing Tier 2 IT issues and proven troubleshooting abilities.

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 also frequently required to stand, and/or walk.  The employee must occasionally lift and/or move up to 50 pounds while moving IT equipment 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 office, manufacturing, and cleanroom environments.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those that 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

ERP Support Analyst

Summary:

The ERP Support Analyst provides project coordination, functional expertise, and contributes to improvements and enhancements for mission-critical, enterprise-wide information systems. The ERP Support Analyst is responsible for project tracking and control for assigned modules or systems, serving as a liaison between functional and technical resources to manage the development of new system functionality, upgrades, system modifications, and day-to-day problem analysis, issue tracking, and resolution.

Responsibilities:

  • Provides 1st and 2nd line global support for Made2Manage ERP (M2M) and Shopfloor Manager (SFM) users.
  • Supports the preparation of our ERP roll outs with regards to master data management, data conversions, providing user access rights in various systems, etc.
  • Provides 1st and 2nd level incident management in relation to incidents that local IT Help Desk cannot deal with and supporting the Global ERP solution and ancillary applications.
  • Supports operation and maintenance of ERP business applications through IT Help Desk ticketing system.
  • Maintenance of end-user documentation and assistance to Quality Assurance of our deployment process.
  • Troubleshoots and tests the ERP system for various scenarios for new releases and updates.
  • Creates and maintains end-user documentation for system updates and release notes.
  • Creates knowledge base articles for frequent issues related issues occurring frequently.
  • Keeps Help Tickets up to date and adheres to defined SLAs by supporting end users and business needs.
  • Engage with stakeholders to understand business requirements and evaluates the feasibility.
  • Performs 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:

  • Typically requires a 4-year degree and a minimum of 5 years of related experience; or an advanced degree without experience; or equivalent work experience.
  • Requires knowledge and experience in own discipline; still acquiring higher level knowledge and skills.
  • Builds knowledge of the organization, processes, and customers.
  • Solves a range of straightforward problems.
  • Analyzes possible solutions using standard procedures.
  • Receives a moderate level of guidance and direction.

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 also frequently required to stand, and/or walk.  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 office, manufacturing, and cleanroom environments.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those that 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, Cleanroom Quality Control

Summary:

The Supervisor, Quality Control position is primarily responsible for providing support and direction in Quality Control. Coordinates closely with Engineering and Production to adhere to production schedules and customer commitments.

Responsibilities:

  • Provide Quality Control support to Manufacturing & Engineering.
  • Coordinate and prioritize the daily activities of Quality Control.
  • Perform inspection or tests on a wide variety of parts and document results.
  • Interact with Quality Engineering to resolve CAPA investigations and in support of Manufacturing.
  • Provide Quality Support for the disposition of discrepant material.
  • Provide Quality Support as needed for product transfers from development to production.
  • Provide leadership to production personnel in relation to quality.
  • Document and issue inspection plans.
  • Recommend the purchase of tools and equipment to improve quality and efficiency.
  • Perform measurement system accuracy and repeatability analysis.
  • Monitor inspection results for shifts & trends.
  • Review DHR’s for completeness, accuracy and conformity to good documentation practices.
  • Review and document procedure changes for quality requirements and compliance with the quality system.
  • Develop quality systems and procedures as needed.
  • Develop and maintain production quality control plans.
  • Initiate and maintain SPC (Statistical Process Control) for production processes.
  • Review existing processes to identify and implement cost, quality and productivity improvements and initiation of corrective action.
  • Review engineering designs for manufacturing feasibility and recommend design changes that will enhance production, eliminate variation and improve quality.
  • Comply with all work rules including those pertaining to safety, health, quality and Cirtec policies.
  • 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-GED.
  • 5 years’ minimum experience in manufacturing, preferably medical devices, with increasing responsibility or a minimum of 10 years’ experience in a manufacturing environment.
  • Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
  • Must possess good 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 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 Design Engineer

Summary:

The Engineer, Mechanical Design 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.

Responsibilities:

  • Owns the design and development of medical devices through:
    • Transformation of internal and external inputs into outputs o Developing design requirements and specifications with mechanical and electrical components and assemblies
    • Creating test methods and corresponding test method validations o Coordinating design verification activities
    • Generating 3D models and engineering drawings utilizing Solidworks o Performing tolerance analyses to ensure component interactions are understood
    • Understanding the functional performance of the products as they are developed o Communicating technical risks as they arise
  • Host design reviews with internal and external stakeholders
  • Manage workload to support various projects, in smaller scale and complexity
  • Maintain compliance to procedures and regulatory requirements
  • 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
  • 1-3 years’ 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

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 maintaining, developing, and implementing robust 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 creative 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
  • 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
  • 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
  • Active participant in Material Review Board (MRB).  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
  • Participate in Kaizens and drive improvement efforts
  • Complies with company, quality and safety standards, policies, and procedures
  • Attends, schedules and leads project meetings to evaluate current and future process 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:

  • Bachelor’s degree in Engineering or related field required
  • Advanced knowledge of manufacturing and assembly processes
  • A minimum of 5 years of engineering experience in a medical manufacturing environment
  • Previous experience with the ability to direct, lead and mentor engineers with respect to company engineering procedures, new product introduction, manufacturing support and tooling
  • Excellent verbal and written communication skills
  • Fluency in English
  • Previous experience with Class III medical devices, FDA standards, ISO 13485 and GMP principles preferred
  • Ability to lead, train, and engage manufacturing team members to reach Cirtec’s quality standards
  • Must be able to read blueprints and interpret technical specifications and illustrations
  • Strong computer skills associated with MS Office suite, Minitab and SolidWorks a plus
  • The capacity to work well under pressure, change priorities on the fly, and take on new challenges
  • Project management skills and the ability to work to tight deadlines
  • Teamwork and people management skills
  • Experience associated with continuous improvement activities like participation in Kaizen events using lean manufacturing principles
  • A practical and logical approach to problem solving using lean six sigma concepts
  • Willingness to travel if required (<5%)

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

Manager, NPI

Summary:

This position is primarily responsible for managing the effective implementation and distribution of new products transfers into pilot production (phase IV) and manufacturing readiness for the eventual transfer to sustained manufacturing (phase V).  Working directly with Engineering and the Pilot Manufacturing Manager to ensure key deliverables, as specified in the design transfer plan, are satisfied prior to transfer.

In addition to product transfer responsibilities, this New Product Introduction position will support customers early into the transfer into sustained manufacturing. These activities include customer communication, change reviews, project proposals, timelines, deliverables, and financial tracking.  This position provides general guidance, support and program coordination with Contract Management, Manufacturing and Manufacturing Engineering to ensure that customer requirements are achieved.

Working with the site leadership, this position will be responsible for leading companywide continuous improvement initiatives which include:  conducting group training sessions, Kaizen facilitation and other activities increasing the company’s cultural awareness of lean principles.

Responsibilities:

  • Direct Pilot Manufacturing team to ensure phase IV pre-launch deliverables are completed prior to transfer into phase V sustained manufacturing.
  • Manage and track design transfer plan deliverables.
  • Assess and report on manufacturing readiness prior to transfer into sustained manufacturing.
  • Maintain a strong knowledge of the company’s manufacturing processes and equipment so able to support Manufacturing and Manufacturing Engineering when troubleshooting issues.
  • Manage day-to-day sustained manufacturing customer support.
  • Serve as primary operations contact with the customer when sustained manufacturing requires communication with the customer on manufacturing issues.
  • Arrange customer meetings to discuss upcoming changes and improvements while instilling confidence in our technical capabilities and product quality.
  • Assist with preparations of proposals and quotations for sustained manufacturing customers.
  • Resolve sustained manufacturing customer questions in a timely manner.
  • Train employees in lean manufacturing principals and six sigma methodologies.
  • Facilitate Kaizen events focusing on waste elimination, standard work, visual controls, 5S, line- balance and product flow.
  • Promote team-based root cause problem solving.
  • Liaison with customers on process improvement opportunities.
  • 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:

  • Ability to meet deadlines and manage projects across several functions.
  • Ability to handle multiple resources, projects and customers at any given time.
  • Above average oral and written communications skills at all levels for technical, personnel and customer contact.
  • Operate effectively and maintain professionalism in an environment of deadlines and high workload.  Adjust work hours to meet changes in priorities.
  • Willingness to travel, if required.
  • Must maintain high ethical standards and demonstrate good organizational skills.
  • A Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or Biomedical Engineering or a closely related engineering discipline and appropriate work experience.
  • Must be able to read, write and speak fluent English.
  • Minimum 3 years’ experience in project management.  Demonstrated ability to lead projects from early-stage development into sustained manufacturing.
  • Minimum 5 years’ experience in an engineering/manufacturing environment with mechanical, tool design and thorough knowledge of manufacturing processes and continuous improvement.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints and specifications.
  • Strong analytical skills.
  • 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

Project Coordinator

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 Project Coordinator, based out of our headquarters in Brooklyn Park, MN, will be responsible for managing and coordinating the development and manufacturing interface, business processes, and engineering NRE metrics.

Responsibilities:

  • Setup project profile in project management/time tracking systems (Fastrack/M2M setup are current systems)
  • Track NRE and expenses to budget
  • Create bi-weekly invoices for project teams
  • Run weekly utilization reports for Program Managers
  • Develop and track COGS from new product development into manufacturing
  • Oversee, track, and communicate project budgets on multiple product development teams.
  • Create purchase orders for project expenses
  • Manage project invoicing
  • Track engineering expenses and report to Program Management and Engineering Management
  • Help track project health in terms of schedule, budget, and technical risks and issues. Prepares and presents comprehensive project status reports to internal and external stakeholders
  • 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:

  • BA/BS Business Administration or related degree
  • Minimum 3 years work experience supporting manufacturing operations
  • Excellent analytical and computer skills
  • Knowledge and proficiency in production, accounting, engineering and materials management
  • MRP/EPR
  • Advanced knowledge of MS Excel

Desired Skills or experience:

  • Experience with new product development
  • Medical Device industry experience
  • 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

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 - VAA Group

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 Project Manager, based out of our headquarters in Brooklyn Park, MN, will be 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.

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.

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

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.
  • Participate in Kaizen events and drive continuous improvement efforts.
  • Complies with company, quality and safety standards, policies, and procedures
  • Attends and schedules project meetings to determine current and future process 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:

  • 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.
  • 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.

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 Project Manager

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 Project Manager, based out of our headquarters in Brooklyn Park, MN, will be 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.
  • 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.

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

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.
  • Participate in Kaizen events and drive continuous improvement efforts.
  • Complies with company, quality and safety standards, policies, and procedures
  • Attends and schedules project meetings to determine current and future process 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:

  • 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.
  • 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.

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

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 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 responsible for being the primary point of contact for strategic account support. Supporting the organization by building strong customer relationships and regular communication with key stakeholders. This individual will work closely with Business Development, Operations, Supply Chain, and Finance to drive production and engineering initiatives. The role focuses on meeting site revenue and profitability objectives, and exceeding customer expectations for delivery and service. This role will support the quoting process, product cost models, customer forecasting, and assisting Operations with customer communication strategies and recovery plans as needed. Finally, this individual will be responsible for developing and updating strategic sales reporting tools.

Responsibilities:

  • Build and maintain relationships with key customer contacts to manage expectations, drive growth within the customer portfolio, and communicate customer needs to the rest of the organization.
  • Monitor customer portfolio revenue and profitability to ensure we are meeting organizational objectives. Develop and present pricing strategies accordingly.
  • Meet with key accounts regularly, virtually and in person to understand their needs and provide insight to Business Development related to risks and future growth.
  • Supports the annual budgeting process by being the primary author of customer demand forecasts. Maintains and updates product forecasts regularly to support Production planning.
  • Addresses customer concerns and requests by coordinating internally, driving activity and timely communication. Escalates major customer topics that require executive engagement.
  • Coordinates Quarterly Business Reviews (QBR) with key account and internal site department managers.
  • Works with Business Development and Legal to establish or update supply agreements with key customers.
  • Regular in person engagement and collaboration with site management and Sales team.
  • 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, MBA preferred; or 8+ years of direct medical device manufacturing experience.
  • Experience working in the medical device industry or a similar regulated industry. A background in Class II and III medical device development or manufacturing is a plus.
  • Program Management skills – ability to understand, review, and manage budgets and timelines.
  • Microsoft Project and general software skills required (Word, Excel, PowerPoint etc.)
  • Excellent communication skills both written and verbal. This is a customer facing role.
  • Contract Manufacturing (CM) Operational experience is a plus.
  • Experience with financial models, gross margin analysis, and cost of goods variables.
  • Experience quoting product design and development activities.
  • Experience building product cost models.
  • Multitasker.
  • Self-motivated.
  • Ability to plan and organize in ambiguous situations.
  • Exceptional communication and problem-solving skills.
  • Critical thinker.
  • Some travel may be 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

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.
  • Participate in Kaizen events and drive continuous improvement efforts.
  • Complies with company, quality and safety standards, policies, and procedures
  • Attends and schedules project meetings to determine current and future process 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:

  • 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.
  • 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.

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 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.

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

Integrated Business Planning (IBP) Analyst

Summary:

The Integrated Business Planning (IBP) Analyst drives the operational business planning processes of Cirtec Medical. As an IBP Analyst, you will compile demand and supply signals from cross-functional teams, analyze trends in data, and communicate planning results to executive and operational staff. The IBP Analyst will drive improvements in both current planning results through increasing accuracy and continual process improvements of the IBP practices of Cirtec Medical.

Responsibilities:

  • Compile multi-site, cross-functional data source into a comprehensive and concise set of scenarios
  • Analyze trends in data sets to identify improvement opportunities and recommend actions
  • Communicate results of monthly business planning scenarios, articulate differences and potential outcomes
  • Provide ad hoc analysis and reporting to leverage data sets and scenarios created from IBP processes
  • Create metrics and resulting dashboards to drive improvements in accuracy of inputs from sites and functions
  • Evaluate and Identify tools needed for improvement of the planning process
  • Drive continuous improvement of current process and creation of new processes to support the growth of Cirtec Medical
  • Track trends in business planning best practices for improvement opportunities

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:

  • 5 years of relevant experience or advanced degree with 2 years of experience
  • Bachelor’s Degree in Supply Chain, Business, Finance, or relevant disciplines preferred
  • Experience working in a matrixed environments to gather inputs and data
  • Demonstrated ability to effectively communicate with executive management and leadership teams
  • Strong data manipulation and analysis experience
  • Knowledge of process definition and improvement techniques

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 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. 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

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; interfaces 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; 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

Machinist I

Summary:

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

Responsibilities:

  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • 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 specifications.
  • May be required to change tool depending upon the job schedule.
  • 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.
  • 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 Machine Technology or equivalent preferred
  • Experience as a CNC Machinist or CNC education required
  • Minimum 2 years of experience programming and operating CNC machine equipment preferred
  • Ability to interpret blueprints, shop drawings, sketches. or other production orders
  • Maintain routine production records
  • Knowledge of trade tools, equipment, materials, micrometer, as well as methods and techniques used in safe machining operations
  • Ability to use precision tools (i.e., calipers) to take accurate measurements
  • Strong attention to quality and detail orientation
  • Mechanical aptitude
  • Mathematical skills
  • Ability to work independently
  • Time management skills to meet schedules and time standards, to best of ability as instructed
  • Strong interpersonal skills to establish and maintain cooperative and effective working relationships
  • Basic understand of geometric dimensions and tolerancing (GD&T), GMP and GDP
  • On-going skills training
  • 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 written and verbal communication skills
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Laser Technician

Summary:

This Sr. Technician, Laser position is responsible for the safe and functional operation of laser cutting and/or welding equipment within the R&D organization.  Will be responsible for developing manual or CAD programs required to weld, 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
  • 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 laser 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
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

HR Generalist

Summary:

This position is primarily responsible is to apply business and human resources knowledge to managers, supervisors and employees regarding the application of HR practices within the company. The Human Resources Generalist performs a wide variety of HR services supporting employee relations, recruiting (online or outside recruiters), benefits, performance management, various types of Leave of Absence administration.  First point of contact to provide information to employees about company policies, benefits and general support.

Responsibilities:

  • Implement and administer employee policies.
  • Provide high-quality advice and service to management on daily employee relations and performance management issues.
  • Excellent problem-solving skills are required to handle unexpected situations.
  • Assist with implementing programs to support improving the employee experience.
  • Maintain ongoing relationships with employment agencies to ensure the selection of qualified talent.
  • Excellent verbal and written communications skills.
  • Ability to work with all levels of staff.
  • Prepare offer letters, termination letters and new hire packets.
  • Schedule meetings with employees when eligible for benefit and new hire onboarding.
  • Administer Leave Program (FMLA, disability)
  • Knowledge of federal and state labor and employment laws.
  • 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:

  • 2-4-year degree in related field or equivalent experience.
  • Experience working with Engineering and Manufacturing organizations required.
  • Excellent presentation, communication and interpersonal skills.
  • Intermediate skill level with Microsoft Excel and Word.
  • Basic writing, reading and arithmetic skills.
  • Strong level of understanding HR related legal issues and HR principles.
  • Able to work alone on a broad variety of projects.
  • Able to exercise effective judgment, sensitivity, creativity to changing needs and situations.
  • Customer-focused attitude; high level of professionalism and discretion.
  • Minimum of 3-5 years’ experience in a multi-disciplinary human resource role with a solid familiarity recruiting, employee relations and benefits administration.
  • Degree, training or equivalent experience in computer use and software-Microsoft Word, Excel and PowerPoint.
  • Experience with HRIS systems (ADP Workforce Now implementation, administration and training a plus.

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 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.
  • Experience examining the data for patterns and trends and working on cross-functional teams.
  • 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.
  • 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.
  • 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:

  • Associates/Bachelor of Science Degree in Manufacturing, Engineering, or Technical Field, or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).
  • 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 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.
  • 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

Software Engineer (iOS, Swift, Xcode)

Summary:

Due to our growth, we are seeking a Software Engineer for the external devices used to control our Class II and III implantable 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 software designs for various external devices associated with active implantable medical devices.
  • 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 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.
  • 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 software development.
  • 1 year of experience programming in Swift and/or Objective C in the XCode IDE.
  • Demonstrated experience working with Human Interface Devices (HIDs).
  • Excellent oral, written, and presentation communication skills.

Preferred Qualifications

  • Database development (SQLite or equivalent).
  • Authentication Server Development knowledge.
  • Online Database development experience.
  • Familiar with IEC 62304.
  • Exposure to Model-based Systems Engineering (MBSE), SysML, UML.
  • Medical device development.

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

Sr. Systems Engineer

Summary:

Based out of our headquarters in Brooklyn Park, MN, the Systems Engineer will be responsible for system-level development and implementation of electronic and software designs for Class II and III medical devices.  The 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. Must be enthusiastic, positive, even tempered and have strong skills in areas of dependability, interpersonal relationships, and communication.

Responsibilities:

  • Create requirements, engineering specifications, and test protocols during 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.
  • 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.
  • 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.

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, Systems Engineering or in an equivalent engineering discipline.
  • Minimum of 3 years of experience in a regulated development environment.
  • 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.
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Manufacturing Engineering Technician

Summary:

This position is primarily responsible for providing tools and support to 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 engineers as needed.

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
  • Responsible for overseeing new production line implementations
  • Maintain compliance to procedures and regulatory requirements
  • Understand and follow safety policies and practices, attend safety training and wear PPE as required
  • Train team leads with new processes
  • 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:

  • FDA, cGMP principles and practices, (ISO 9001, ISO 13485)
  • 3 Plus years’ experience in the engineering/manufacturing environment for medical devices
  • Ability to learn and comprehend the ESN process
  • Experience with Silicone molding is a plus
  • 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

Coil Winding Technician

Summary:

This position is primarily responsible for the manufacturing and assembly of sterile and non-sterile medical devices.  Responsible for setting up and operating workstations, monitoring production rated and running associated systems used in manufacturing products sold to our customers.  May be performing visual and dimensional inspections needed to ensure quality in the products Cirtec manufactures.

Responsibilities:

  • Has the standard function of operating workstations used in manufacturing processes
  • Proficient in set-up and loading component materials into product specific tool
  • Responsible for following established documentation for product manufacturing
  • Demonstrates strict adherence to all safety procedures, GMPs, GDP, quality system guidelines and company policies
  • Accurately documents all work performed on inspection reports and customer travelers
  • Must have a general understanding of the CNC controlled workstations on the production floor
  • Reads and follows process control documents, work instructions, and standard operating procedures
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions
  • 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 various dimensional inspection using specific dies or gauges, or dimensional inspection systems, verniers and micrometers
  • Provides direction within the manufacturing cell to Tech I associates assigned to assist them
  • Performs basic workstation set up and troubleshooting tasks
  • Performs additional duties as required under the direction of the Supervisor
  • Maintains cleanliness of work areas, machines, tools, and equipment
  • Assists Quality Control with inspection duties as required
  • Recognizes quality issues and communicates these issues to Quality and/or Supervisor
  • 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 General Education Degree (GED) is required
  • Associates Degree or minimum of 2-4 years’ experience in medical device industry
  • 2+ years’ experience in a technical field
  • Strong attention to detail
  • Knowledge of ISO & FDA requirements
  • Experience with LEAN manufacturing a plus
  • Strong interpersonal and communication skills, including both verbal and written communication
  • Ability to provide detailed information to engineers for determining root cause in order to identify the appropriate corrective actions
  • Ability to track fine details visually and discover defects in the inspected parts
  • Be able to read, write and speak fluent English

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

Customer Service Representative

Summary:

This position is primarily responsible for interfacing with Customers, Business Development, Manufacturing Leadership, and Planning as related to incoming orders and delivery dates.  The Customer Service Representative will process orders, prepare correspondences, and fulfill customer needs to ensure customer satisfaction.

Responsibilities:

  • Provide customers with delivery information based on Value Stream Meeting (VSM) driven from the planning team and update dates within M2M (Enterprise Resource Planning System).
  • Handle daily calls and correspondence with customers and sales reps on purchase orders/sales orders.
  • Keep records of customer interactions, process customer accounts and file documents.
  • Prepare and provide customer open order reports as required.
  • Work with Business Development on new and revised quotes for new and revised purchase orders.
  • Contribute to team effort by accomplishing related results as needed.
  • Communicate with internal and external customers in a cooperative and professional manner.
  • Build sustainable relationships of trust thorough open and interactive communication.
  • Assist to help Cirtec meet sales order promise date(s).
  • Be proactive in representing the customer to reach and maintain a high level of customer satisfaction.
  • 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:

  • Proven customer support experience
  • Customer orientation and ability to adapt/respond to different types of characters
  • Excellent communication
  • Ability to multi-task, prioritize and manage time effectively.
  • High school diploma or equivalent
  • Top Skills & Proficiencies: Customer Service, ERP, Product Knowledge, Quality Focus, Documentation Skills, Listening Skills, Phone Skills, Resolving Conflict, Multitask, Patience, Positive Attitude, Attention to Detail, People Oriented, Analysis, Problem Solving, Organizational Skills, Ability to Work Under Pressure, Computer Skills

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 encounter while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Chandler, AZ

Sr. Product 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 Senior Product Engineer is based out of our Chandler, AZ office. The Senior Product Engineer is responsible for developing and maintaining test solutions for all internal Cirtec and customer ASIC products. The ideal candidate can develop test solutions on the selected test platforms used by Cirtec such as D10, ASL1K/3K, and/or Catalyst. This position also requires the management of test development and product testing at third party vendors. The candidate will also oversee the production yield and product delivery of ASIC’s and application specific standard products (ASSP).

Responsibilities:

  • Lead creation of test specifications, test verification plans and release of test verification reports
  • Provide product engineering, test engineering and backend support for a product or range of IC products through all phases of product development and production
  • Collaborate with design engineers to develop a post silicon evaluation plan, support bench evaluation and debug of silicon, and support development of production tests
  • Monitor production yield and delivery, and lead troubleshooting and resolution of yield issues
  • Manage test houses and backend vendors, and monitor vendor performance
  • Work closely with quality engineering on root cause investigation, CAPAs or SCARs related to product testing
  • Assist with project management, schedule tracking and allocation of technical resources
  • 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 Computer or Electrical Engineering, or in other relevant engineering discipline
  • Minimum 8 years of experience with testing and production of ICs
  • Detailed understanding of diagnostic, product test, failure analysis and debug techniques
  • Good understanding of semiconductor manufacturing, packaging, and testing
  • Solid understanding of circuit design, semiconductor process and device physics
  • Experience working within a Quality Management System (e.g. ISO 13485, ISO 9001) preferred
  • Self-starter with strong communication skills and demonstrated problem solving ability
  • 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.

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

Project Manager

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 Project Manager, based out of our facility in Chandler, AZ, will be responsible for coordinating and managing activities related to design, production and testing of medical ASICs.

Responsibilities:

  • Manage and coordinate activities related to design and production of ASICs and other electronic assemblies intended for medical devices
  • Generate and maintain project plans, schedules, task lists and project risk registers that enable the team to execute project activities based on well-defined prioritization
  • Coordinate activities across different functional groups within the company, customers and suppliers to ensure successful completion of project goals and milestones
  • Track 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 anticipate project risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions
  • Create and maintain documentation per company procedures and ISO 9001/13485 requirements
  • Coordinates and directs customer meetings and visits, and day-to-day customer communication
  • Interfaces with suppliers to drives schedules and manage priorities
  • Analyze gross profit reports and manage financial aspects of internal and customer programs
  • Analyze relevant information, trends, and data to support decision making
  • 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 science or engineering discipline with 3+ years of industry experience
  • Prior experience with project management highly desired but not required
  • Experience with IC design and/or production desired but not required
  • Ability to interpret product requirements, design specifications and technical documents preferred
  • Ability to communicate complex 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

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. 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

Engineer II, Manufacturing

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.
  • Participate in Kaizen events and drive continuous improvement efforts.
  • Complies with company, quality and safety standards, policies, and procedures
  • Attends and schedules project meetings to determine current and future process 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:

  • 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.
  • 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.

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. Engineer, Laser Application

Summary:

This position is responsible for providing hands-on process development and manufacturing direction for new customer and internal laser projects; develops and establishes procedures to qualify and validate customer requirements; assist the development and manufacturing organizations in weld design, tooling, fixtures, and parameters for new and existing programs.  Provides training to ensure production meets Cirtec’s quality and efficiency specifications.  The ideal applicant is a hands-on person who enjoys working with laser technology and CNC programming; good work ethic and strong interpersonal skills; customer presence; excellent organization skills; and enjoys working with machinery and electronics.

Responsibilities:

  • Provide technical expertise to develop new or make improvements to existing laser equipment with a drive to increase process efficiency, product quality and cost.
  • Understands laser dry box welding, atmosphere controls such as, O2 analyzers, gas chromatographs and vacuum bake chambers.
  • Establishing weld parameters that will ensure product will maintain quality and functional requirements through its life cycle.
  • Adheres to Cirtec’s values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
  • Develops novel laser processing solutions to establish and improve laser processing capabilities.
  • Interface with customers, suppliers, and internal cross-functional team members to develop specifications, coordinate prototype fabrication of customer designed parts, and transition prototypes into manufactured components.
  • Project member for new design and development teams requiring laser processing.
  • Implements new laser systems, fixtures, and processes for welding.
  • Provides planning inputs and executes on project deliverables to meet established metrics.
  • Conduct process validation activities.
  • Provide cost-saving initiatives by evaluating manufacturing processes while maintaining quality standards.
  • Create and analyze prototype products.
  • Generates, reviews and approves engineering change orders.
  • Investigates root cause for product and process failures and establishes corrective actions.
  • Design experiments to provide data-based conclusion about a process or product performance.
  • Provide assistance to develop laser quotations and manufacturing procedures.
  • Understand CNC Programming to create welding and cutting programs
  • Use SolidWorks for tool and fixture design
  • Research and recommend capital equipment for the yearly budget
  • Write laser processing procedures
  • Provide process training to production operators
  • Develop inspection procedures to verify acceptability of components
  • Maintain and promote laser and team safety
  • Evaluate and recommend alternative manufacturing methods
  • 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.

Qualifications:

  • BS in Physics or Mechanical Engineering or equivalent is required
  • Minimum five years Laser experience, within the Medical Device industry highly preferred
  • Experience with weld development of active implants, neuromodulation, and/or complex electromechanical medical devices highly preferred
  • Laser Safety Officer training preferred
  • Knowledge of AWS requirements
  • Certificate in Laser application preferred
  • Able to program cutting and welding operations.
  • Must be able to make clear and accurate decisions
  • Excellent reading, writing, communication, and organizational skills
  • Develop plans for managing projects
  • Executes and reports on verification and validation efforts
  • Experience with ISO quality systems and World Class Manufacturing principles
  • Strong professional communications, negotiation, and problem-solving abilities

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.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. Engineer, Quality

Role Competencies:

  • Adaptability: Adapts to widely varied needs
  • Attention to Detail: Proposes tools and methods to ensure accuracy when completing complex tasks
  • Change Management: Applies the competency in new or complex situations and advises others.
  • Client Focus: Provides seasoned advice
  • Collaborating with Others: Fosters collaboration
  • Decision Making: Makes complex decisions in the face of ambiguity
  • Problem Solving: Solves complex problems
  • Product and Service Development: Applies the competency in new or complex situations and advises others.
  • Quality Focus: Sets quality standards for area of responsibility
  • Quality Management and Assurance: Applies the competency in new or complex situations and advises others.
  • Supplier Relationship Management: Applies the competency in the full range of typical situations, requiring guidance in only the most complex or new situations.
APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Materials 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.

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

Opportunities in Los Gatos, CA

Materials 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
  • 4-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

HR Generalist

Summary:

The Human Resource Generalist is primarily responsible for the daily functions of the Human Resource (HR) department including hiring and interviewing staff, administering pay, benefits, and leave, and enforcing company policies and practices. The HR Generalist is typically the first point of contact to provide information to employees about company policies, benefits and general support.

The Human Resources Generalist performs a wide variety of HR duties to support employee relations, recruitment, onboarding, benefits, performance management, and various types of leave of absence administration.

Responsibilities:

  • Reviews, tracks, and documents compliance with mandatory and non-mandatory training, continuing education, and work assessments. This may include safety training, anti-harassment training, professional licensure, and aptitude exams and certifications.
  • Implements and administers company policies.
  • Recruits, interviews, and facilitates the hiring of qualified job applicants for open positions; collaborates with departmental managers to understand skills and competencies required for openings.
  • Conducts or acquires background checks and employee eligibility verifications.
  • Implements and conducts new hire orientation.
  • Performs routine tasks required to administer and execute human resource programs including but not limited to compensation, benefits, and leave; disciplinary matters; disputes and investigations; performance and talent management; productivity, recognition, and morale; occupational health and safety; and training and development.
  • Prepares offer letters, promotion letters, termination letters, and new hire packets.
  • Handles employment-related inquiries from applicants, employees, and supervisors, referring complex and/or sensitive matters to the appropriate staff.
  • Attends and participates in employee disciplinary meetings, terminations, and investigations.
  • Complies with company, quality and safety standards, policies and procedures.
  • Maintains compliance with federal, state, and local employment laws and regulations, and recommended best practices; reviews policies and practices to maintain compliance.
  • Maintains knowledge of trends, best practices, regulatory changes, and new technologies in human resources, talent management, and employment law.
  • Performs 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:

  • 2-4-year degree in related field or equivalent experience.
  • Experience working with Engineering and Manufacturing organizations required.
  • Strong level of understanding HR related legal issues and HR principles.
  • Excellent presentation, communication and interpersonal skills.
  • Intermediate skill level with Microsoft Excel and Word.
  • Basic writing, reading and arithmetic skills.
  • Able to work alone on a broad variety of projects.
  • Able to exercise effective judgment, sensitivity, creativity to changing needs and situations.
  • Customer-focused attitude; high level of professionalism and discretion.
  • Experience with HRIS systems implementation, administration and training a plus.

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. Quality Engineer

Summary:

The Sr. Engineer, Quality position is primarily responsible for Design Control (product development), Manufacturing, Regulatory compliance, qualitative and quantitative data analysis, complaint investigation and analysis, Training, Metrology and Gage R&R, and other Quality functions.

Additionally, this role is expected to provide input and contribute on Quality System strategies and approach.

Responsibilities:

  • Develop and perform operational and process qualifications for customer manufacturing processes in conjunction with other engineering departments.
  • Assist with the development / update of FMEA and Hazard Analysis in conjunction with other  engineering departments.
  • Initiate the development / update of FMEA and Hazard Analysis in conjunction with other engineering departments per project requirements.
  • Generate the Quality Plan for development projects.
  • Provide direction in implementing Incoming Inspection plan, First Article Inspection plans, In-Process and Final Product Inspection.
  • Create appropriate sampling plans along with identifying inspection and acceptance criteria.
  • Review and/or document Design Control activities for Project Phase Reviews and Product Verification testing as required per project requirements.
  • Perform vendor audits and qualifications.
  • Represent quality engineering in phase reviews and other aspects throughout product development.
  • Implement, plan, and execute continuous improvement projects for quality improvements and efficiency from conception to fully established production.
  • Member of customer and 3rd party quality audit team.  May be required to lead this effort.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPA’s, CCR’s and NCMR’s.
  • Provide trending analysis on CAPA, NMR and other quality metrics.
  • Provide quality oversight on maintaining ISO Class 7 clean rooms including review and trending of the testing and monitoring reports.
  • 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:

  • AS/BA/BS in Quality Engineering or related discipline.
  • Minimum experience in medical/manufacturing environment: 5 years (BS) OR 10 years (AS).
  • Extensive experience with medical device QSRs in design control and production environments.
  • Strong familiarity with Class II or Class III medical devices requirement.
  • Knowledge of FDA/cGMP and MDD regulations/guidelines.
  • Experienced with ISO13485 or equivalent.
  • 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.
  • PREFERRED REQUIREMENT: CQE certification, Experience with Application Specific Integrated Circuit (ASIC) design and production preferred.
  • Strong verbal and written communication skills, including technical report writing.
  • Ability to work with a wide variety of functional areas, including R&D, Manufacturing, and QA, as  required accomplishing results with minimal guidance.
  • Demonstrated use of Quality tools/methodologies including: Design Control, Risk Analysis (Hazard Analysis), Design FMEA, Process FMEA, Statistical Analysis, and Gauge R&R.

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 Development Manager

Summary:

This position is primarily responsible for developing relationships, increasing visibility and growing sales for the Cirtec Medical Interventional Segment. This segment includes the design, development and commercialization of devices that require Nitinol tubing, Nitinol processing, complex catheters, delivery systems and full-device-assembly.  End markets include Structural Heart, Electrophysiology and Neurovascular.

Responsibilities:

  • Generate and develop a pipeline of opportunities for Cirtec’s Interventional Segment
  • Increase the visibility and customer awareness of the Interventional offering
  • Meet or exceed sales goals
  • Negotiate contracts with prospective clients along with support from manager
  • Prepare weekly and monthly reports on pipeline targets
  • Present the overall Cirtec product offerings and capabilities to prospects with a focus on the Interventional business
  • Provide timely, accurate quotes for delivery to prospect
  • Hunt for new accounts and new applications
  • Assist with sales pipeline management by working with key sustaining customers to obtain an accurate 12 month rolling forecast.
  • Work with Associate Business Service Manager and other key stakeholders to manage and drive Quarterly Business Reviews with customers.
  • Other responsibilities as assigned
  • Travel 20% – 50% for Customer trips, site tours, trade shows
  • Major sites are located in Los Gatos, CA – Brooklyn Park, MN – El Coyol, Costa Rica

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:

  • Three years sales experience with medical device implants – (TAVR, stents, Nitinol, catheters a plus)
  • Demonstrated success selling to start-ups, major OEMs, R&D engineers, purchasing departments and senior management
  • Exceptional communication and problem-solving skills
  • Ability to plan and organize independently
  • Must be proficient with Microsoft Office Word, Excel and PowerPoint (SFDC a plus)
  • Bachelor’s Degree, (MBA Preferred)
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

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

Responsibilities:

  • Creates mechanical designs and applies engineering knowledge and skills as technical engineer during all phases of design and development
  • Generates and maintains 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 desired product performance, cost, reliability, and manufacturability requirements
  • Develop test plans and protocols and executes prototype testing and design verification testing
  • Creates engineering-level process instructions, bill of materials and related documentation
  • Assists in release and revision control of component drawings, specifications and other design documentation through the document control system
  • Effectively interfaces with suppliers to source and fabricate components
  • Participates in risk management activities (e.g. DFMEA) 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:

  • BS in Mechanical or Biomedical Engineering, or an equivalent engineering discipline
  • Minimum 2 years’ experience with development of medical devices
  • Experience and working knowledge of medical device design control process preferred
  • Proficiency with CAD design using SolidWorks required
  • 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: PPE

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.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Software 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.

Based out of our facility in Los Gatos, CA, the Sr. Software (Embedded) Engineer will be mainly responsible for development and integration of embedded software for novel Class 2/3 medical devices.

Responsibilities:

  • Lead and coordinate design, implementation and testing of embedded software.
  • Participate in software system architecture development and document software requirements and development plan.
  • Perform detailed design analysis and reviews with hardware engineering team to achieve product performance, cost, reliability and manufacturability requirements.
  • Track software related issues and lead resolution of issues with a well-documented and methodical approach.
  • Develop software test and verification plans and protocols, and conduct prototype testing and verification testing.
  • Work closely with hardware engineering team to debug/integrate software with hardware.
  • Collaborate with program managers to create and manage development plans and project plans related to software development.
  • Lead and contribute towards creation of software design history file, risk management documentation, issue tracking, configuration management, etc.
  • Develop and maintain relevant documentation (for e.g. specifications, designs, test plans and reports, etc.) required for medical product Design History Files.

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 Electronics or Computer Engineering or in an equivalent engineering discipline.
  • Minimum 10 years’ experience in embedded software development in the medical device industry or a highly regulated industry.
  • Experience with Texas Instruments and Zarlink microcontrollers, DSP, SPI.
  • Extensive experience programming in C and C++
  • Strong HW / SW bring-up and debugging skills.
  • Capable of working independently in a hardware lab with oscilloscopes, signal generators, power supplies and other test equipment.
  • Knowledge and understanding of IEC 60601 and IEC 62304 and other relevant medical device regulatory standards highly preferred but not mandatory.
  • Must be able to read, write and speak fluent English, and must possess 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.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Operations Manager

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 headquarters in Los Gatos, CA, the Operations Manager will be mainly responsible for managing the manufacturing operations and overseeing the production staff and supply chain team.

Responsibilities:

  • Manage and coordinate the activities of production staff and supply chain team. Provide technical guidance on issues pertaining to manufacturing operations.
  • Provide sustaining support to manufacturing lines and ensure all equipment are operational and efficient. Monitor manufacturing lines routinely to ensure efficiency and output metrics are achieved.
  • Oversee qualification and validation activities for new materials, processes, equipment, and products into manufacturing. Lead transfer activities in accordance with customer needs and company goals.
  • Actively collaborate with quality and engineering teams to resolve manufacturing and/or supplier quality issues for clinical and sustained production.
  • Serve as the principal contact for sustained manufacturing customers, and actively collaborate with the customer to understand demand, and create/update resource plans to meet that demand.
  • Oversee materials core team to identify and forecast engineering and sustained manufacturing demand for materials, plan inventory levels and ensure timely flow of materials to meet demand.
  • Manages and supports production and test equipment maintenance, qualification and calibration.
  • Oversee the hiring, training, and monitoring of operations staff. Mentor and motivate team members to excel at their level of performance and to achieve their highest potential.
  • Leads investigation and troubleshooting of designs and processes when defects occur to determine root cause, and implement effective containment and preventive measures.
  • Lead planning and scale-up of operational activities to support the growth of the business.
  • Develop and implement health and safety policies to ensure a risk-free and safe work condition. Conduct risk assessments to analyze risks and operational hazards.
  • Proactively identify and lead continuous improvement activities, Serve as the Operations team representative on the internal CAPA board.
  • Perform other responsibilities 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 an Engineering or a relevant discipline.
  • 10+ years of experience working in an manufacturing and/or operations environment, with minimum 5 years of experience in medical device manufacturing.
  • Prior experience with operations management or with leading manufacturing teams highly preferred.
  • Experience with lean manufacturing techniques, value stream mapping, and continuous improvement methodologies preferred.
  • Strong knowledge of GMP and ISO 13485 regulations.
  • Strong computer skills, including the MS Office suite.
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral.
  • Must have demonstrated organizational skills to manage multiple priorities and schedules.

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 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.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Lowell, MA

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

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

Technician, 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:

  • 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 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

SMT Engineer II

Summary:

This 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 (internal and external).
  • Assist with preparation of proposals and quotations. May be required to interface with clients 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.
  • Develop process and capacity utilization strategies for SMT assembly operations.
  • Develop paste printing, automated paste inspection, component pick and place, reflow profile, and inspection processes.
  • Assists is the selection of SMT/SMD equipment
  • Operates SMT equipment in support on production and process development
  • Identify the root cause of quality issues and develop corrective action plans to improve.
  • Ensure the production readiness of SMT processes within the PCBA cycle.
  • Design optimum production processes such as solder paste selection, reflow profiles, stencil designs, component feeder set up methodology, and selective soldering techniques.
  • Optimize equipment set up and programming sequences.
  • Write DFM reports in support of customer proposals.
  • Manipulates electronic data files using Gerber, OB++, various CAD packages, and 3D modeling such as AutoCAD and Solidworks
  • 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:

  • Must be able to fully interpret technical drawings, blueprints, specifications & illustrations.
  • Able to follow clean room and ESD policies, become familiar with and practice 6S principles in order to maintain a safe, neat, and orderly workplace.
  • 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.
  • A Bachelor’s degree in an engineering discipline and minimum 4 years appropriate work experience; or Associates degree in engineering discipline and a minimum or 6 years appropriate work experience; or a minimum of 10 years relevant work experience; or equivalent.
  • Must have extensive knowledge with surface mount and through-hole technologies.
  • Must be familiar with IPC/EIA J-STD-001 and IPC-A-610.
  • Must have working knowledge of all SMT assembly and inspection processes.
  • Must have a working knowledge of printed circuit board CAD data and assembly equipment programming software, and databases.
  • Strong computer skills, including the MS Office suite and MS Project.
  • 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.

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: Standard PPE and cleanroom garments

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.

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

Production Planner

Summary:

This position is primarily responsible for assisting with planning routines and methods for the innovation and re-engineering of company products. The position will include the standard production planning responsibilities including coordination with purchasing, materials, scheduling, customer service, and project teams as required by production demand. This position is also responsible for strategic projects as assigned.

Responsibilities:

  • Coordinate production workflow for one or multiple products.
  • Plan and prioritize operations to ensure maximum performance and minimum delay.
  • Determine manpower, equipment and raw materials needed to cover production demand.
  • Assign workers and other staff to particular production operations.
  • Schedule shift according to production needs.
  • Monitor jobs to ensure they will finish on time and within budget.
  • Address issues when they arise aiming for minimum disruption.
  • Obtain output information (number of finished products, percentage of defectives etc.)
  • Prepare and submit status and performance reports.
  • Keep paperwork organized.
  • Collaborate with quality control, warehouse, and other staff.
  • 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 or equivalent and/or five to ten years’ experience in Manufacturing (i.e., resource planning, production control, manufacturing performance standards). CPM/APICS qualifications preferred.
  • Must be able to read, write, and speak fluent English.
  • Minimum 5 years’ experience in a manufacturing environment.
  • Possess a broad experience with planning systems and mid-level volume production requirements, preferably, in a medical device manufacturing environment. Prior experience in the implementation of ERP/MRP systems is a plus.
  • Knowledge of computerized inventory and MRP systems, word processing and spreadsheet/database software required.
  • Proven ability to effectively interface with internal and external customers to understand month to month production requirements and ensure adjustments are communicated to all parties.
  • Must be detail-oriented with excellent organizational skills as well as excellent oral and written communication skills.
  • Must be self-motivated with the ability to work independently with minimal supervision.
  • Knowledge of cGMP’s, ISO and FDA requirements a plus.
  • Experience in medical device or pharmaceutical industry preferred.
  • Prior experience in a Contract Manufacturing Operation (CMO) is preferred.
  • Preferred candidate will have relevant experience in planning for operational performance and regulatory compliance.

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

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

Manager, Engineering

Summary:

The Manager, Engineering position is primarily responsible with functional supervision to the engineering department, consisting of research and development engineers and technicians, and mechanical designers.   The Engineering Manager will serve as Project Manager and/or technical lead for projects including validation and documentation of new product services, and expansion of existing product services including defining requirements, timelines, and deliverables.

Responsibilities:

  • Provide support & supervision to direct reports for the timely completion of projects, initiatives and key activities.
  • Mentor associates and foster a learning and growth environment.  Perform evaluations at regular intervals.
  • 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.
  • Ensure team is performing under the Cirtec quality system and with good engineering practices.
  • Ensure R&D, design and tooling resources are meeting project needs in both availability and talent in a multi-project environment.
  • Ensure that projects stay on schedule and are fully documented as required by medical device regulatory agencies.
  • Oversee the process of developing new or modified products ensuring compliance to internal, regulatory, and customer requirements.
  • Provide leadership for teams that will execute projects in all aspects of the development process to include: requirement and specification definition, risk management, design development, process development, sourcing and supply chain, prototype builds, device verification testing, process qualification, and transfer into manufacturing.
  • Manage day-to-day oversight of engineering support of the manufacturing operation for assigned customers after product release as necessary.
  • Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a 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:

  • A Bachelors’ degree in an engineering discipline or equivalent.
  • Minimum 7 years’ experience in an engineering/manufacturing environment.
  • Demonstrated ability to lead engineering teams successfully from early stage development to production.
  • 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.
  • Above average 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 and adjust schedule or work hours to meet changes in priorities.
  • High ethical standards, good organizational skills.
  • 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.
  • Ability to train new engineering employees 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 and illustrations.
  • Technical report preparation and formal presentation skills.
  • Ability to learn and apply new technology.
  • Exceptional knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics.
  • 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

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

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:

  • Be able to read, write and speak fluent English.
  • Associates degree or equivalent experience in a related field
  • 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

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.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com