Senior Design Assurance Engineer — Medical Device; Onsite — Arbor Lakes, MN

Senior Design Assurance Engineer — Medical Device (Onsite — Arbor Lakes, MN) Contract

Maple Grove, United States | Posted on 05/11/2026

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at  and follow us on Linked In:

Job Role: Senior Design Assurance Engineer — Medical Device (Onsite — Arbor Lakes, MN) Contract

Job Summary: The Sr Design Assurance Engineer provides focused quality engineering leadership on sustaining design assurance activities. Design assurance drives the ISO
14971 risk management process and the Verification & Validation (V&V) process. This includes quality plans, risk management plans and reports, hazard analysis, product risk management workbook (user FMEA and design FMEA), sampling systems / procedures and statistical techniques, verification protocols/testing/reports, validation protocols/testing/reports. This role will be responsible for supporting risk document and post market record review during remediation activities as well as ensuring quality and compliance through post commercialization sustaining activities.

• Bachelor’s degree in mechanical, electrical, biomedical engineering, or related discipline
• 5+ years of related experience in design assurance, new product development, or related medical device or regulated industry experience
• Understanding of electrical safety standards IEC 60601
• Experience with reliability testing
• Demonstrated use of Quality tools/methodologies

Preferred Qualifications:

• Experience with class III medical devices
• BS in Electrical Engineering
• Previous R&D experience
• Strong knowledge of QSR and ISO standards
• ASQ certification

Pharmavise Corporation is an Equal Opportunity Employer and does not discriminate on the basis of race or ethnicity, religion, sex, national origin, age, veteran disability or genetic information or any other reason prohibited by law in employment.