Senior Design Assurance Engineer (Med Device – Onsite)

• Job Tag:
• Posted: October 27,2025
• Salary: $150,000
  
  

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.