Senior Design Assurance Engineer

We’re looking for a Senior Design Assurance Engineer in Maple Grove, MN to support innovative medical device development. You’ll lead design assurance activities, ensure compliance with regulatory standards, and collaborate with cross-functional teams to bring safe, high-quality products to market.

Ideal candidates : 5+ years in design assurance, strong knowledge of FDA / ISO / IEC regulations, experience with risk management and design controls, and excellent problem-solving skills. Experience with DHF, DMR, and technical files.