Staftonic LLC is hiring: Principal Software Quality Engineer (Medical Device) in

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.