Senior Design Assurance Engineer

A growing medical device company in the Twin Cities is hiring a Senior Design Assurance Engineer to lead quality and compliance efforts throughout product development. This individual will partner closely with engineering to ensure design activities align with FDA and ISO requirements while supporting a smooth path from concept to commercialization.What You’ll DoOwn and guide the design control process (inputs, outputs, V&V, changes) to ensure regulatory compliance.Drive risk management activities (ISO 14971), including hazard analysis and FMEA, from early development through launch.Support and review verification and validation strategy, protocols, and reports.Maintain and ensure integrity of the Design History File (DHF).Collaborate cross-functionally with R&D, Manufacturing, Regulatory, and Quality teams.Contribute to audit readiness, CAPA, investigations, and continuous improvement efforts.Apply statistical tools (DOE, SPC, reliability analysis, Minitab) to support data-driven decisions.Assist with product transfer into manufacturing.What You BringBachelor’s degree in Engineering (or related technical field).5+ years of medical device quality/design assurance experience.Strong knowledge of Design Controls, ISO 13485, ISO 14971, and 21 CFR Part 820.Experience with risk management, process validation, and statistical analysis.ASQ certification (CQE or CMQ-OE) preferred.Comfortable in fast-paced or early-stage environments.Strong communicator who can influence across technical teams.*No relocation or visa sponsorship available.