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

Engineer II, Quality Design and Development

Summary:

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

Responsibilities:

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

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

Qualifications:

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

WORKING ENVIRONMENT

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

EEO STATEMENT

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

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

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Buyer Planner - NovelCath

Summary:

The Buyer Planner is responsible for procuring materials, supplies, equipment, and services, from internal and external sources. The Buyer Planner creates and manages production schedules for internal sources and partners with Suppliers to ensure NovelCath/Cirtec Medical is adequately supplied. The Planner collaborates with Operations, Buyers, Subcontractors, and Engineering to align supply with demands.

Responsibilities:

  • Create, modify, and manage Job Orders and Purchase Orders for assigned workstreams/sites to ensure on time Customer fulfillment.
  • Communicate schedule deviations to internal and external stakeholders.
  • Ensure a ready supply is available for assigned categories, ensure effective inventory management, and maintain metrics to drive continuous improvement.
  • Optimize supply routes to ensure Quality, Delivery, then Cost. Employee a total cost of ownership (TCO) model to make/buy decisions.
  • Develop and maintain positive, assertive relationships with internal and external partners and Suppliers.
  • Evaluate Materials Requirement Planning (MRP) outputs to determine efficient supply.
  • Maintain accurate planning parameters in Enterprise Resource Management (ERP) systems.
  • 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 3 to 5 years of experience in Supply Chain, manufacturing, planning, purchasing, sourcing, or related disciplines.
  • Experience working in a manufacturing environment with Contract Manufacturing preferred.
  • Demonstrated experience in production planning, scheduling, and or procurement.
  • Understanding of Materials Requirements Planning, Enterprise Resource Planning, and Advanced Planning systems and methodologies.
  • Knowledge of planning, procurement, and inventory management strategies.
  • Proficient in office support applications such as Outlook, Excel, and messaging platforms.
  • Strong problem solving and collaboration skills, demonstrated through successful negotiations and positive outcomes.

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:

The Planner is responsible for creating, modifying, and managing production plans and schedules. The Planner drives production operations to ensure on time fulfillment for Customers while maintaining efficient utilization of Cirtec Medical resources and capacity. The Planner collaborates with Operations, Buyers, Subcontractors, and Engineering to align supply with demands

Responsibilities:

  • Create, modify, and manage production Plans and Schedules for assigned workstreams/sites to ensure on time Customer fulfillment.
  • Communicate schedule deviations to internal and external stakeholders.
  • Create and maintain capacity models to drive mid-range Rough Cut Capacity Planning (RCCP).
  • Partner with Supervisors and Managers in assigned workstreams to optimize production plans for current capacity and staffing levels.
  • Develop and maintain positive, assertive relationships with partners in Operations, Engineering and Quality.
  • Ensure a ready supply is available for assigned categories, ensure effective inventory management, and maintain metrics to drive continuous improvement of plans.
  • Collaborate with Buyers to optimize inventory levels and identify make/buy opportunities.
  • Evaluate Materials Requirement Planning (MRP) outputs to determine efficient Job Order creation and management.
  • Maintain accurate planning parameters in Enterprise Resource Management (ERP) systems.
  • 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 3 to 5 years of experience in Supply Chain, manufacturing, planning, purchasing, sourcing, or related disciplines.
  • Experience working in a manufacturing environment with Contract Manufacturing preferred.
  • Demonstrated experience in production planning and or scheduling.
  • Understanding of Materials Requirements Planning, Enterprise Resource Planning, and Advanced Planning systems and methodologies.
  • Knowledge of inventory management strategies.
  • Proficient in office support applications such as Outlook, Excel, and messaging platforms.
  • Strong problem solving and collaboration skills, demonstrated through successful negotiations and positive outcomes.

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, Manufacturing Engineering

Summary:

Cirtec Medical is a contract manufacturing company located in Brooklyn Park, MN.  We build products that help save and enhance peoples’ lives.  Come join our growing team!

The Manager, Manufacturing Engineering position is primarily responsible for functional supervision to the engineers and technicians. The Engineering Manager will serve as a technical lead for projects including validation and documentation of new product services, and expansion of existing product services including defining requirements, timelines, and deliverables in operations.

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.
  • 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 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 to 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.

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, Supplier Quality

Summary:

The primary duty of the supplier quality engineer is to review and assess manufacturing procedures, typically by visiting vendor facilities and observing their manufacturing environment. These visits may occur as part of the supplier selection process, or after the company has established a relationship with a vendor. They may also revisit supplier facilities to determine if requested changes have been incorporated.  This role may be located in the Enfield, CT or Brooklyn Park, MN site.

Responsibilities:

  • Performs re-assessment of suppliers each year per a defined schedule
  • Tracks supplier responses and conducts follow-up and escalation as necessary
  • Reviews current Quality Agreements and determines need to revise. Solicits revised Quality Agreements as determined
  • Obtains and analyzes performance and quality indications information from internal sources for each supplier
  • Prepares and submits required quality records and documents for closure and filing
  • Manages the development of supplied product inspection procedures and first article requirements
  • Assesses supplier capabilities through direct visits, technical discussions, directed testing and quality system audits
  • Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests, and technical discussions
  • Participates and provides engineering ownership for all supplies product Non-Conforming Material Reviews
  • Works with Manufacturing engineering to assess and address purchased product issues
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues
  • Coordinates component qualification and process validations activities for new & existing products
  • Performs quality system and process audits for initial supplier qualification and/or ongoing monitoring purposes
  • Utilizes various failure investigation techniques, statistical process control, protocol and report preparation and non-conforming product controls
  • Provides technical support for quality assurance or project groups in using GMPs for medical device environment
  • Reads and utilizes engineering drawings
  • Coordinates CAPA activities
  • Performs assessments on designated manufacturing/product lines areas to identify and address gaps
  • Supports Customer Complaint Investigations
  • Participates in cross-functional and/or departmental team projects
  • Carries out implementation of changes through change review process
  • 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 in Engineering or technical field
  • 4 years’ experience in quality engineering
  • 4 years’ experience in Supplier Quality Engineering in the medical device field
  • Experience with CAPAs, process validation, design controls, and risk management
  • Ability to use GDT processes
  • Solid communication and interpersonal skills
  • Advanced computer skills, including statistical/data analysis and report writing skills
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Strong organizational and follow-up skills, as well as attention to detail

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, Production - 2nd Shift

Summary:

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

Responsibilities:

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

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

Qualifications:

  • Associates degree or equivalent experience in a related field.
  • Minimum 3+ year’s supervisory experience in a manufacturing environment, preferably in a medical device manufacturing environment and in leadership role. Must be able to read, write and speak fluent English.
  • 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.

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

Sales Engineer

Summary:

This position is primarily responsible for combining technical knowledge with sales skills interacting directly with the customer or supporting the Business Development team.  The customers are typically Medical Device OEM’s

Responsibilities:

  • Field sales calls, maintains and develops existing customer relationships with regular phone calls and face-to-face meetings.
  • Presents a consultative sales approach to determine the best solution for the customer.
  • Assist Business Development team with technical sales as required.
  • Follow up on leads that are determined to be house accounts.
  • Engages the appropriate resources to assist with the sales process.
  • Focus on the sale of assemblies, neurostimulation leads and minimally invasive devices utilizing the company’s vertical capabilities.
  • Perform market research to determine potential customers.
  • Assist engineering to develop proposals.
  • Assist in meeting sales team yearly sales projections.
  • Develop and maintain communication with our employees and customers in a cooperative and professional manner.
  • Be proactive in representing the customer to allow Cirtec to reach and maintain a high level of customer satisfaction.
  • Prepare reports for 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:

  • Bachelor’s Degree in Engineering with strong technical background
  • 5+ years of medical device contract manufacturing experience
  • Technical selling experience with minimally invasive devices, nitinol, catheters and other implantable devices
  • Knowledge of precision machining desired
  • Familiar with CRM software like Salesforce
  • Advanced computer competency
  • Willingness to travel up to 25%

 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:

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

Responsibilities:

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

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

Qualifications:

  • Analyze and process Information, Promote Process Improvement, Developing Standards, Managing Processes, Manufacturing Methods and Procedures, Supports Innovation.
  • Bachelor of Science or equivalent, preferably in an engineering discipline.
  • Minimum experience in medical/manufacturing environment: 2-5years (BS) OR 5-6years (AS) OR 7 years (ND).
  • Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
  • Must possess excellent verbal communication, organizational and management skills.
  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access.
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.

 WORKING ENVIRONMENT

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

EEO STATEMENT

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

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

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Human Resources Manager

Summary:

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

Responsibilities:

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

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

Qualifications:

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

WORKING ENVIRONMENT

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

EEO STATEMENT

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

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

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

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.

EEO STATEMENT

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

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

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Facilities Technician II

Summary:

Ensure that all facility systems operate optimally to mitigate negative impacts to customer service, quality operations, engineering and any/all other Cirtec BP internal customers. Primary responsibilities include monitoring, maintaining, operating and general oversight of facility systems, equipment, building and grounds. Provide general facility services to internal customers to ensure optimal customer service. Assist with projects as assigned regarding design, planning, installation, operations, removal, commissioning, qualifications, and documentation. Assist with developing, refining, and updating preventative and predictive maintenance procedures and documentation. Work directly with contracted services as assigned.

Responsibilities:

  • Perform routine facility work tasks as required to meet internal customer service needs
  • Collaborate consistently and effectively with EHS to ensure a safe and clean working environment
  • Perform assembly, installation, removal, testing, calibration, and maintenance of facility equipment and systems
  • Assist with facility project planning, definition, implementation, execution, and completion of tasks
  • Document, analyze and communicate work performed, actions, irregularities, and continuous improvement needs
  • As needed, act as point of contact for outside contractors regarding facility equipment or systems scheduling, planning and work.
  • Assist with developing, documenting, deploying, and sustaining the predictive and preventive facilities maintenance program.
  • Assist with maintaining equipment parts and supplies inventories.
  • Provide professional communications to internal customers, contractors, suppliers, and vendors.
  • Ability to promote the company’s goals of quality, customer service and continuous improvement through employee engagement
  • 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:

  • Associate degree in a technical field such as Mechatronics, Electronics Technology, Electrical Systems, Computerized Control Systems, or Industrial Maintenance Technician is preferred.
  • Alternatively, 5 or more years related manufacturing mechanical maintenance experience and/or maintenance of facility systems equipment.
  • Professional Certification in a discipline such as: Pneumatics / Hydraulics, Electrical Systems, PLCs Robotics, Control Systems, or other electro-mechanical disciplines is beneficial.
  • Consistent performance as a professional, effective, and positive member of the department and organization.
  • Strong verbal and written communication skills; ability to interact effectively with all team members, management, internal customers, contractors, suppliers, vendors, and engineering
  • Flexibility to alter or adjust work schedules or locations is required to meet the demands of the business.
  • The ability to respond to on-call emergencies is required.
  • Ability to utilize a wide range of core facility maintenance, industrial repair, and/or trade skills confidently and accurately
  • Organization and prioritization skills; ability to manage multiple priorities based on business needs. Skill with risk assessment and mitigation
  • Read and write English with good comprehension, comprehend instructions, understand short correspondence. Clearly write correspondence. Effectively present information in one-on-one and small group situations to other employees of the organization.
  • College level algebra is beneficial. Ability to add, subtract, multiply, and divide, in all units of measure and in basic mathematical formulas, using whole numbers, common fractions and decimals.
  • Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Deal with problems and/or situations involving several variables.
  • Intermediate level skills for clerical and administrative procedures and systems such as computer functions, word processing, spreadsheets, e-mail, internet, managing electronic and hardcopy files and other basic tasks.

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

Assembler II

Summary:

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

Responsibilities:

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

Qualifications:

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

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:

Required Skills or Experience:

  • 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:

  • BA/BS Business Administration or related degree is preferred
  • 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

Sr. Engineer, Systems

Summary:

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

Responsibilities:

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

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

Qualifications:

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

 PREFERRED QUALIFICATIONS

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

WORKING ENVIRONMENT

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

EEO STATEMENT

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

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

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Assembler II

Summary:

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

Responsibilities:

  • ESSENTIAL FUNCTIONS:
    • Support Engineers and technicians on development products relating to defined customer needs or as possible proprietary items. This also may include the adaptation of existing designs to new-customer applications.  These designs may be in the form of freehand sketches or final detail drawings, depending on timing and available drafting time.
    • Construction of prototypes and development builds to meet customer and internal requirements.
    • Testing of new-product prototypes to verify product reliability.
    • Notes process steps and parameters.
  • ADDITIONAL RESPONSIBILITIES: 
    • Assists the engineering department in regard to product redesign to resolve product or production difficulties.
    • Performs other duties when required or requested.

Qualifications:

  • Must be familiar with a variety of manufacturing processes and materials.
  • Three (3) years’ on-the-job experience as product builder.
  • An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

EEO STATEMENT

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

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

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Engineer

Summary:

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

Responsibilities:

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

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

Qualifications:

  • Analyze and process Information, Promote Process Improvement, Developing Standards, Managing Processes, Manufacturing Methods and Procedures, Supports Innovation.
  • Bachelor of Science or equivalent, preferably in an engineering discipline.
  • Minimum experience in medical/manufacturing environment: 1-2 years (BS) OR 4 years (AS) OR 7 years (ND).
  • Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
  • Must possess excellent verbal communication, organizational and management skills.
  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access.
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.

WORKING ENVIRONMENT

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

EEO STATEMENT

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

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

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Engineer, Mechanical Design

Summary:

The Senior 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. Lead the design efforts for small to medium scale programs, independently, acting as a technical lead and mentor to other engineers on these programs.

Responsibilities:

Owns the design and development of medical devices through:

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

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

Qualifications:

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

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, Packaging Design

Summary:

The Sr. Engineer, Packaging Design is primarily responsible for defining, developing, and designing packaging for medical devices. Owns efforts in developing solutions to packaging class II and class III medical products by translating requirements from the customer into realized designs. Able to multitask and run multiple projects while meeting customer commitments.

Responsibilities:

Owns the design and development of medical device packaging through:

  • Transformation of internal and external customer inputs and requirements into results
  • Developing packaging design specifications
  • Generate 3D models and engineering drawings utilizing Solidworks
  • Working with internal and external sources to create concepts and prove function
  • Planning and leading test methods, design verification and validation activities
  • Host design reviews with internal and external stakeholders
  • Manage workload to support various projects
  • Maintain compliance to procedures and regulatory requirements
  • Provides regular status updates to management and or customer
  • Writes/updates work instructions, 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:

  • 3-5 years of experience in packaging design, of particular interest would be within the medical field.
  • Use of mechanical design (SolidWorks, PTC or other), statistical analysis (MatLab, MiniTab or other)
  • Knowledgeable in ISO, ASTM, ISTA standards and test methods related to packaging
  • Experience with terminally sterilized package design, materials, sealing methods, operating room
  • procedures and sterilization methods.
  • FDA, cGMP, GDP principles and practices, (ISO 9001, ISO 13485)
  • Proficiency with Solidworks required
  • 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. 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

Manufacturing Technician II

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.
  • Reads and follows process control documents, work instructions, and standard operating procedures
  • 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
  • Must have a general understanding of the CNC controlled workstations on the production floor
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions
  • 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

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

Sr. Quality Engineer

Summary:

This position is primarily responsible for Design Control (product development), Regulatory compliance, qualitative and quantitative data analysis, complaint investigation and analysis, Manufacturing support, 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.
  • Manage the internal audit system schedule and perform the duties of a Lead Auditor including    training internal auditors.
  • Perform internal audits to assess compliance to FDA and ISO 13485 requirements, as well as the internal Quality System, including investigation observations and findings and reporting.
  • 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 NMR’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
  • 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.
  • 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 requirements.
  • Knowledge of FDA/cGMP and MDD regulations/guidelines.
  • Experienced with ISO13485.
  • 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.
  • 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.

PHYSICAL DEMANDS

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

WORKING ENVIRONMENT

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

EEO STATEMENT

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

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

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Machinist II - Swiss

Summary:

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

Responsibilities:

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

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

Qualifications:

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

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

Machinist I - Swiss

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.
  • For Press Room:
    • 1 to 3 years minimum experience setting up and operating automatic mechanical punch presses and various other types of equipment.
    • Ability to perform a variety of moderate stamping, drawing and forming operations, which includes the use of compound, combination and some progressive dies.
    • Able to setup a variety of different tools from simple to complex with supervision.

WORKING ENVIRONMENT

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

EEO STATEMENT

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

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

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Technician I, 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

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

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 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

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

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

Machinist I - EDM

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

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

Opportunities in Chandler, AZ

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

Manufacturing Engineering Technician

Summary:

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

Responsibilities:

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

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

Qualifications:

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

WORKING ENVIRONMENT

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

EEO STATEMENT

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

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

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. Mechanical Design Engineer

Summary:

The Sr. Mechanical Designer position is primarily responsible for developing and designing medical devices, tooling and fixtures from concepts and sketches utilizing SolidWorks while complying with industry drafting standards. Activities completed in this position must be implemented in accordance with Good Manufacturing Practices, Good Documentation Practices, ISO and FDA requirements.

Responsibilities:

  • Generate 3D models and Engineering drawings utilizing SolidWorks
  • Concept design
  • Design detailed tooling, gage, and fixture engineering drawings 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
  • Review engineering drawings to ensure adherence to specifications and standards
  • Design reviews
  • 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 ECN’s for drawing release and revisions
  • 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:

  • Associates degree in an Engineering discipline or related field
  • 7 plus years’ experience in the engineering/manufacturing environment (Machining, Finishing, and assembly) for medical devices related to product and tool design
  • FDA, cGMP, GDP principles and practices, (ISO 9001, ISO 13485)
  • 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

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, 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

Opportunities in Los Gatos, CA

Manufacturing Technician

Responsibilities:

  • Has the standard function of operating workstations used in manufacturing processes.
  • Will work in other areas of production on the manufacturing floor as needed based on production and priorities.
  • Proficient in set-up and loading component materials into product specific tool.
  • Apply adhesives to small components using needles, EFD dispensers, and syringes.
  • Responsible for following established documentation for product manufacturing.
  • Demonstrates strict adherence to all safety procedures, GMPs, GDP, quality system guidelines and company policies.
  • Reads and follows process control documents, work instructions, and standard operating procedures. Fill out design history files (DHR) as required.
  • 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 additional duties as required under the direction of the Supervisor.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Recognizes quality issues and communicates these issues to Quality and/or Supervisor.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Follow Manufacturing Process Instructions (MPIs) to build and inspect medical devices.
  • Other duties as assigned.

Skill Sets Desired:

  • Fine dexterity for assembling small components and good attention to detail.
  • Good understanding of GMP, Clean room procedures and behavior.
  • Ability to use tools and measurement devices.
  • Ability to use automated equipment.
  • Good communication skills to describe issues or observations as they are observed.
  • Must be able to document activities clearly.
  • Basic computer and writing skills.
  • Must be a team player.

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.
  • Strong attention to detail.
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions.
  • Knowledge of ISO & FDA requirements.
  • Experience with medical device manufacturing including following good manufacturing practices (GDP).

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

Operations Manager

Summary:

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.

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. Electrical 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. Electrical Engineer will be mainly responsible for design and development of electronic systems for novel Class II/III medical devices.

Responsibilities:

  • Develop and implement electronic circuit designs for medical devices, including designs for high-voltage waveform generators, neuromodulation devices, embedded control, battery systems and power management
  • Lead schematic design and layout of printed circuit assemblies using computer-assisted design (CAD) software tools, breadboard and prototype development, testing and troubleshooting
  • Design and lead the construction of electronic test equipment for use in development and manufacturing
  • Generate specifications, technical drawings and other relevant design documentation to ensure that electronic designs conform to customers product requirements and applicable standards
  • Collaborate with software engineers to specify, test and verify embedded software in the system
  • Build, test, debug, and maintain configuration of breadboards and prototype assemblies
  • Develop test methods and protocols, and execute prototype testing and formal design verification
  • Develop and maintain documentation for specifications, designs, Failure Mode Effects Analysis (FMEA), risk management, and test protocols and reports for product Design History Files
  • Participate in the development of quality inspection and manufacturing process instructions for PCBs and other electronic assemblies
  • 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 Electrical or Computer Engineering. Advanced degree preferred
  • Minimum 8 years of experience in development of electronic products in the medical device industry or a similarly regulated industry
  • Experience in design and development of electronics for neuromodulation, wireless charging and communication, embedded controls, battery systems and power management circuits, and real-time signal processing highly preferred
  • Expertise in electronic design automation tools: e.g. PCB design (Altium preferred), schematic capture, analog and digital circuit simulation, tolerance analysis
  • Knowledge and understanding of relevant medical device regulatory standards such as IEC 60601 highly preferred but not mandatory
  • Ability to write C/C++ code for embedded microprocessors highly preferred but not required
  • 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.

EEO STATEMENT

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

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

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Mechanical Engineer

Summary:

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

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

Responsibilities:

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

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

Qualifications:

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

PHYSICAL DEMANDS

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

Protective Clothing Required: None

WORKING ENVIRONMENT

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

EEO STATEMENT

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

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

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

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

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

Opportunities in Lowell, MA

Technician I, Engineering

Summary:

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

Responsibilities:

  • Run equipment tests, collect data and analyze data with the engineering team.
  • Make recommendations on how to improve the quality or efficiency of a process based on data and observation.
  • 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.
  • Reliable, consistent and punctual attendance is an essential function of the job.
  • Other duties as assigned.

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

Qualifications:

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

WORKING ENVIRONMENT

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

EEO STATEMENT

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

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

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Production Supervisor - Weekend 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.
  • 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.
  • Other duties as assigned.

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

Qualifications:

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

PHYSICAL DEMANDS

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

Protective Clothing Required: None

WORKING ENVIRONMENT

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

EEO STATEMENT

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

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

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Production Team Lead - Weekend 2nd Shift

Summary:

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

Responsibilities:

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

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

Qualifications:

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

PHYSICAL DEMANDS

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

Protective Clothing Required: None

WORKING ENVIRONMENT

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

EEO STATEMENT

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

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

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Materials Coordinator

Summary:

This position is primarily responsible for inventory control, job order material usage reconciliation, material movements, and chemical inventory management. 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.
  • Track, reconcile and maintain chemical levels per regulations set forth by state and federal requirements.
  • Disposal of hazardous material per regulations set forth by state and federal requirements.
  • 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 2 years’ experience in a manufacturing environment, which includes operation of an automated inventory control system.
  • Inventory management and control disciplines.
  • Chemical and or hazardous material training and certification preferred.
  • Experience supporting 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

Production Team Lead - Weekday 1st Shift

Summary:

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

Responsibilities:

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

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

Qualifications:

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

PHYSICAL DEMANDS

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

Protective Clothing Required: None

WORKING ENVIRONMENT

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

EEO STATEMENT

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

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

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

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

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

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

General Referral Application

General Referral

Don’t see a position that fits your background and experience? We are always accepting applications and resumes that we keep on file. If we open a new position that better fits your background and experience we can review your general referral application.

Email CareersAtCirtec@Cirtecmed.com