Catheter Engineer

Senior Design Assurance Engineer leading design control activities from concept to commercialization for medical device product development. Responsibilities include creating and ensuring on-time Quality Plans for internal development and CPDP projects, leading Design Verification and Validation planning and root-cause investigations, driving Risk Management from concept through commercialization, developing test methods and leading method validation, ensuring DHF content integrity and regulatory compliance, supporting audit responses and product re-certifications, establishing customer and product requirements, defining component specifications and supplier qualifications, supporting biocompatibility and sterilization qualifications, and providing oversight and direction to team members (potentially 2-3 technicians). On-site, Fridley, MN with focus on quality operations and regulatory adherence.