Quality Design

4 weeks ago

Enfield, United States Cirtec Medical Full time

About us:

For over three decades, Cirtec Medical has been a leading provider of manufacturing solutions for complex Class II and III medical devices. We specialize in providing comprehensive services from design and development to manufacturing and finished device assembly. Our expertise spans active implants and neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenge, you may be a perfect fit for our team

* Please note - Sponsorship is not available for this role

Position Summary:

The Quality Design & Development Engineer I 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.

Key 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).
  • 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.
  • Reliable, consistent, and punctual attendance is an essential function of the job
  • Complies with company, quality, and safety standards, policies, and procedures.

This is not a remote position.

Must Have:

  • Bachelor's Degree in an Engineering related field required
  • 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.
  • Must be able to read, write and speak fluent English
  • Knowledge in the application of risk management

Good to Have:

  • ASQ Certification

Cirtec Medical Corporation considers everyone 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 its related companies fully endorse equal opportunity. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create an enjoyable work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life. Our benefits include training and career development, healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.

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