Senior Software Quality Engineer

West500 PartnersRedmond, WA
Hybrid

About The Position

Our growing healthcare technology client, which develops innovative technology for epilepsy treatment, needs a Senior Software Quality Engineer to join their team to ensure the reliability and compliance of their medical devices. They're seeking candidates with experience working across both hardware and software systems, along with a background in software verification, requirements-based testing, and FDA-compliant quality processes. This is an exciting opportunity for an established QA Engineer to contribute to the development of life-changing medical technologies. This is a hybrid role based in the Redmond, WA area. Candidates are expected to work onsite 1-2 days per week (additional onsite collaboration 2-4 times per year, lasting 4-5 days onsite).

Requirements

  • 8 years of experience in software quality assurance and/or software test engineering.
  • Background in the medical device industry is essential.
  • Knowledge of FDA regulations 21 CFR Part 820, IEC 62304, and ISO 14971 standards.
  • Experience with Python, Linux, GUI, Bluetooth/wireless communication systems.
  • Bachelor’s in CS or related degree.

Nice To Haves

  • Startup or high-growth company experience.

Responsibilities

  • Ensure the reliability and compliance of medical devices.
  • Contribute to the development of life-changing medical technologies.
  • Work across both hardware and software systems.
  • Perform software verification.
  • Conduct requirements-based testing.
  • Adhere to FDA-compliant quality processes.
  • Create and execute software test plans, test cases, and test procedures.
  • Support software quality processes including requirements reviews, design reviews, defect management, and continuous process improvement.
  • Work hands-on in a lab environment.
  • Collaborate cross-functionally with engineering teams.
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