Principal Software Quality Engineer (Medical Device)Staftonic LLC • Bellevue, WA, United States

Principal Software Quality Engineer (Medical Device)

Staftonic LLC • Bellevue, WA, United States

1 day ago

Job type

Full-time

Job description

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 :

8+ 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.

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Principal Quality Engineer • Bellevue, WA, United States

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