Twin Cities Metro, MN | 6-Month Contract Hybrid – 3 days onsite
We’re looking for a Senior Design Assurance Engineer to support combination drug/device new product development (TDP phase) and integration activities. This role is ideal for someone who thrives in cross-functional environments and enjoys building compliant, risk-based solutions that drive safe and effective products to market.
What You’ll Do
Lead design assurance activities for new product development projects
Create and maintain risk management documentation (dFMEA, pFMEA, hazard analysis, risk reports)
Support GLP studies with protocol oversight and documentation
Partner with R&D, Regulatory, and Operations on combination product development and design transfer
Contribute to regulatory submissions through DHF documentation, validation reports, and technical content
What We’re Looking For
Bachelor’s degree in Engineering, Life Sciences, or related field
5+ years in Design Assurance/Quality Engineering within medical devices or combination products
Hands-on experience with risk documents, GLP studies, and combination drug/device development
Strong knowledge of FDA 21 CFR Part 4, Part 11, Part 820, ISO 13485, ISO 14971
Excellent communicator with proven cross-functional collaboration skills
Bonus: Experience with Windchill and MasterControl
