Senior Design Assurance Engineer (Software)
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).
Desired Skills and Experience
Bachelor's in technical field 5+ years med device software QA; mastery of ISO 14971, HIPAA/GDPR; risk tools like dFMEA; strong MS Office/JIRA skills. Preferred: ASQ certs, GHTF validation experience. Relocation support available for MN move.
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