Senior Design Assurance Engineer - Medical Device; Onsite - Arbor Lakes, MN
Job in
Maple Grove, Hennepin County, Minnesota, 55311, USA
Listed on 2026-06-02
Listing for:
Pharmavise
Contract
position Listed on 2026-06-02
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer, Medical Device Industry
Job Description & How to Apply Below
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 and follow us on Linked In:
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 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.
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 ISO
14971
- 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
Position Requirements
10+ Years
work experience
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×