SkyWater has partnered with a dynamic, people-first medtech powerhouse in the Minneapolis metro area to attract and hire a Senior Design Assurance Engineer. With a collaborative culture that champions diverse voices, we’re building a community of innovators who prioritize patient impact over bureaucracy.
As Sr. Software Design Assurance Engineer, you’ll champion quality for non-device apps (patient/physician portals) and device-adjacent software in Class III implants. Partner cross-functionally to audit deliverables, drive risk management, validate test environments, and enforce IEC 62304/FDA compliance – from concept to commercialization. Mentor a growing team, tackling audits, ECOs, and cyber controls in a hybrid setup (Mon-Thu onsite).
