Staftonic LLC
Principal Software Quality Engineer (Medical Device) Job at Staftonic LLC in Was
Staftonic LLC, Washington DC, Washington DC, US
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.