Sr. Software Quality Engineer

Medtronic Diabetes

Base: $102,400.00 - $153,600.00 usd; bonus/equity:...
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Bachelor's degree with 4 years experience
Fda cfr mdr iec 62304 iso 13485 compliance
Design history file document review
** Medtronic Diabetes is seeking a Senior Software Quality Engineer who will support quality assurance efforts for cardiac electrophysiology systems. The role requires strong collaboration with cross-functional teams to ensure compliance with regulatory standards and to drive continuous improvement in product reliability. **

Job Summary

  • This role involves leading quality efforts for Affera cardiac electrophysiology systems while ensuring strict adherence to FDA and ISO regulatory standards.
  • The position requires collaborating with cross-functional teams to review Design History Files and drive continuous improvement in software reliability and security.
  • Medtronic offers a competitive salary range of $102,400 - $153,600 along with comprehensive benefits including health insurance, 401(k) matching, and incentive plans.

Matching Summary

Match Score: 75

** Medtronic Diabetes is seeking a Senior Software Quality Engineer who will support quality assurance efforts for cardiac electrophysiology systems. The role requires strong collaboration with cross-functional teams to ensure compliance with regulatory standards and to drive continuous improvement in product reliability. **

Salary

Base: $102,400.00 - $153,600.00 USD; Bonus/Equity: Eligible for Medtronic Incentive Plan (MIP); Benefits: Health, Dental, Vision, 401(k), PTO, Tuition assistance

Skills & Requirements

Must-have

  • Bachelor's degree with 4 years experience
  • FDA CFR MDR IEC 62304 ISO 13485 compliance
  • Design History File document review
  • Software risk analysis and defect assessment
  • Post-market activity and CAPA support

Nice-to-have

  • Python Qt Docker Linux experience
  • Cardiac electrophysiology specialty knowledge
  • Six Sigma or ASQ certification
  • Cybersecurity in regulated environments
  • Hands-on lab time and case attendance

Key Requirements

  • Bachelor's degree plus 4 years relevant experience
  • 2+ years medical device or regulated industry experience
  • Unrestricted US work authorization required at hire

Work Rights

Must have unrestricted US work authorization at time of hire

Tailored Resume

Cover Letter