Design Assurance Engineer

Location: Arbor Lakes, MN (Hybrid – onsite days required) Assignment Dates: July 27, 2026 – July 26, 2027 Pay Rate: $43.04–$54.95/hr Work Authorization: Must be authorized to work in the U.S. without current or future sponsorship A global medical‑technology manufacturer is seeking a Quality Engineer III to support design assurance activities for a commercialized Class III therapy device. This role focuses on maintaining design‑control documentation, risk‑management files, usability deliverables, and verification/validation readiness to ensure ongoing product safety, quality, and regulatory compliance. Role Overview The Quality Engineer III will work cross‑functionally to review, update, and maintain design‑control deliverables and risk‑management documentation for a commercialized medical device. You will support lifecycle maintenance, design changes, usability assessments, and quality investigations while ensuring compliance with internal procedures and regulatory expectations. Key Responsibilities Verification & Validation — Review V&V activities and plan/execute updates or testing needed to meet internal and external requirements. Design History File — Maintain the DHF and collaborate with R&D on Design Input/Output documentation, including product and component specifications. Work with cross‑functional teams to identify required updates and implement effective design controls. Maintain product risk‑management documentation , including Hazard Analysis, Fault Trees, and FMEAs . Maintain and update the usability file ; support usability planning, assessments, and documentation. Participate in the design‑change process , ensuring proposed changes are thoroughly analyzed through design‑control requirements. Apply structured problem‑solving methodologies to identify, prioritize, and resolve quality issues. Communicate findings, risks, and recommendations clearly across technical and non‑technical teams. Minimum Qualifications Bachelor’s degree in Biomedical Engineering , Mechanical Engineering , or related technical field. 4+ years of engineering experience. Strong communication skills with proven examples of effective cross‑functional collaboration. Hands‑on, proactive approach to problem solving. Ability to work effectively in both onsite and remote environments. Highly adaptable and able to work independently or within a team. Thorough understanding of quality systems and design‑control principles . Hybrid schedule with required onsite days at Arbor Lakes. Possible extension beyond initial 12‑month term. Interview process may include two video interviews with cross‑functional teams. #J-18808-Ljbffr Advantage Technical