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

Pharmavise Corporation; Maple Grove (MN); Vor Ort; USD 110.000 - 140.000; Vollzeit

Zusammenfassung

Pharmavise Corporation is seeking a Senior Design Assurance Engineer for an onsite role in Arbor Lakes, MN. The position focuses on leading design assurance activities, driving ISO 14971 risk management, and overseeing V&V efforts for medical devices in a contract engagement.

Responsibilities include creating quality plans and risk management workflows, supporting post-market activities, and ensuring compliance with QSR and ISO standards, with an emphasis on reliability and electrical safety.

Qualifikationen

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

Aufgaben

• Lead design assurance activities and drive ISO 14971 risk management processes.
• Support V&V, verification protocols, tests and reports for quality and compliance.
• Assist in risk documentation and post-market record review during remediation activities.

Kenntnisse

Quality tools/methodologies

Electrical safety knowledge

Reliability testing

Ausbildung

Bachelors in Mechanical/Electrical/Biomedical Engineering

Jobbeschreibung

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 www.pharmavise.com and follow us on LinkedIn: https://www.linkedin.com/company/pharmavisecorp

Job Description

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

Overview:

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 www.pharmavise.com and follow us on LinkedIn: https://www.linkedin.com/company/pharmavisecorp

Our F500 Medical Device client has an exciting opportunity for a Senior Design Assurance Engineer.

Job Summary:

The Sr Design Assurance Engineer provides focused quality engineering leadership on sustaining design assurance activities. Design assurance drives the ISO14971 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.

Requirements

Required Qualifications

• 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.