We are seeking an experienced Quality Engineer II to support New Product Development (NPD) and Design Quality initiatives for Class III medical devices. This role will play a key part in design integration, DHF remediation, risk management, and verification & validation activities while partnering with cross-functional engineering teams.
Key Responsibilities
- Support New Product Development (NPD) and Design Quality activities throughout the product lifecycle.
- Lead and execute Design History File (DHF) remediation and design integration initiatives.
- Develop and execute Verification & Validation (V&V) protocols and reports.
- Apply Design for Manufacturing (DFM) principles during product development.
- Support risk management activities, including Risk Management Files, FMEA development, and traceability.
- Ensure compliance with FDA Quality System Regulations, Design Controls, and applicable industry standards.
- Collaborate with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Operations to deliver high-quality products.
Required Qualifications
- Bachelor's degree in Engineering or a related scientific discipline.
- 5+ years of Quality Engineering experience in the medical device industry.
- Strong background in New Product Development (NPD) and/or Design Quality.
- Hands-on experience with Design Controls and 21 CFR Part 820.
- Experience leading or executing Design History File (DHF) remediation and/or design integration projects.
- Strong technical expertise in Verification & Validation (V&V) and Risk Management, including developing and executing testing strategies—not just participating on project teams.
- Experience with Class III vascular medical devices, such as catheters, stents, guidewires, or similar technologies.
- Excellent problem-solving, communication, and cross-functional collaboration skills.
Preferred Qualifications
- Experience supporting large-scale integration or remediation projects.
- Working knowledge of Design for Manufacturing (DFM) principles.
- Familiarity with risk management tools and methodologies (e.g., FMEA, ISO 14971).
This is an excellent opportunity for a Quality Engineer with deep technical expertise in Design Quality and medical device development to contribute to innovative Class III medical device programs.
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Job Disclaimer:
Equal Opportunity Employer/Veterans/Disabled
Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client
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The Company will consider qualified applicants with arrest and conviction records.
Pay: $50.00 - $60.00 per hour
Benefits:
- Dental insurance
- Health insurance
Work Location: In person
