Senior Design Assurance Engineer — Medical Device (Onsite — Arbor Lakes, MN) Contract
On-siteMaple Grove, Minnesota, United States
Job Summary
Lead focused quality engineering leadership on sustaining design assurance activities, driving ISO 14971 risk management and Verification & Validation processes. Execute quality plans, risk management plans, and reports including hazard analysis, user and design FMEA, and statistical sampling procedures. Manage verification and validation protocols, testing, and reports while supporting risk document and post-market record reviews during remediation. Ensure quality and compliance through post-commercialization sustaining activities for a Class III medical device client. This onsite contract role in Arbor Lakes, MN requires a Bachelor's degree in engineering and 5+ years of design assurance experience.
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
Desired 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
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