Sr Software Qa Engineering

Dexcom Inc

Base: $95,900.00 - $159,900.00; bonus/equity: not ...
Iec 62304 compliance knowledge
Iso 13485 regulatory experience
Fda 21 cfr part 820 expertise
This role provides technical support to ensure conformance to software development processes and safety regulations like IEC 62304 and ISO 13485

Job Summary

  • This role provides technical support to ensure conformance to software development processes and safety regulations like IEC 62304 and ISO 13485.
  • The engineer will lead pre-market risk management deliverables including SHA and design FMEA while supporting cybersecurity efforts.
  • Candidates will benefit from a comprehensive benefits program, global growth opportunities, and access to in-house learning programs.

Matching Summary

This role provides technical support to ensure conformance to software development processes and safety regulations like IEC 62304 and ISO 13485.

Salary

Base: $95,900.00 - $159,900.00; Bonus/Equity: Not specified; Benefits: Comprehensive program included

Skills & Requirements

Must-have

  • IEC 62304 compliance knowledge
  • ISO 13485 regulatory experience
  • FDA 21 CFR Part 820 expertise
  • Software design control deliverables review
  • Risk management (SHA, FMEA) leadership

Nice-to-have

  • ASQ Certified Software Quality Engineer certification
  • Cybersecurity risk management experience
  • Cloud-based infrastructure familiarity
  • Agile and Waterfall methodology understanding
  • Strong cross-functional communication skills

Key Requirements

  • Bachelor's degree in technical discipline
  • 5-8 years related industry experience
  • Medical device compliance experience required
  • ASQ CSQE certification preferred

Work Rights

Not specified

Tailored Resume

Cover Letter