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

Pharmavise Corporation • Maple Grove, MN

1d • Onsite

About The Position

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.

Requirements

• 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
• Strong written/verbal communication skills.
• Risk documentation per ISO14971

Nice To Haves

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

Responsibilities

• Provides focused quality engineering leadership on sustaining design assurance activities.
• Drives the ISO14971 risk management process and the Verification & Validation (V&V) process.
• Develops 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.
• Supports risk document and post market record review during remediation activities.
• Ensures quality and compliance through post commercialization sustaining activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior