Principal Software Quality Engineer (Medical Device) (Bellevue)Staftonic LLC • Bellevue, WA, US
Principal Software Quality Engineer (Medical Device) (Bellevue)
Staftonic LLC • Bellevue, WA, US
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job_description.job_card.job_description8+ years in medical device quality engineering. Experience in both embedded and non-embedded software. Proficient with statistical tools (e.g., Minitab). B.S. / M.S. in Engineering or related field. ASQ CQE or Six Sigma certification preferred. Bonus : AI, cloud, or SaMD experience.
Principal Software Quality Engineer (Medical Device)
Bellevue, Washington
Long Term Project
Key Responsibilities :
- Oversee design control, risk management, verification, and validation for software and hardware.
- Ensure compliance with FDA 21 CFR 820, ISO 13485 / 14971, IEC 60601, 62304, and 62366.
- Manage risk files (RMF, FMEA) and design documentation.
- Perform software quality reviews, including code, security, and BOM oversight.
- Support CAPA, process improvements, and quality system updates.
Qualifications :
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