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

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 Strong written/verbal communication skills. Risk documentation per

ISO14971

Preferred Qualifications:

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