Base: $140,600 to $198,000 py; bonus/equity: incen...
Hybrid
Medical device software quality assurance
Fda 21 cfr part 11 and part 820 compliance
Iso 13485 iso 14971 iec 62304 regulations
This role is responsible for ensuring software quality objectives are met throughout the Product Development Process for complex medical devices
Job Summary
This role is responsible for ensuring software quality objectives are met throughout the Product Development Process for complex medical devices.
The position requires navigating complex government regulations including FDA 21 CFR Part 11, Part 820, ISO 13485, ISO 14971, and IEC 62304.
Employees receive comprehensive benefits including incentive plans, a 401(k) match, paid time off, and an Employee Stock Purchase Plan.
Matching Summary
This role is responsible for ensuring software quality objectives are met throughout the Product Development Process for complex medical devices.
Salary
Base: $140,600 to $198,000 per year; Bonus/Equity: Incentive plans and Employee Stock Purchase Plan available; Benefits: 401(k) match, short-term disability, paid time off, and holidays
Skills & Requirements
Must-have
Medical device software quality assurance
FDA 21 CFR Part 11 and Part 820 compliance
ISO 13485 ISO 14971 IEC 62304 regulations
AAMI TIR45 programming languages C C++ C# Python SQL
Minitab statistical analysis and process improvement
SFMEA SFTA reliability tools implementation
Software validation automation testing V&V
Nice-to-have
Cross-functional team coordination skills
Cybersecurity knowledge in medical devices
Design History File management experience
Product lifecycle management expertise
Key Requirements
Bachelor's degree with 7 years or Master's with 5 years of software engineering experience
Minimum 5 years experience coordinating cross-functional groups for medical device software quality
Proven expertise in MDPD, SDLC, and specific regulatory frameworks (FDA/ISO)
Hands-on experience with AAMI TIR45 standards and multiple programming languages
Experience reviewing and dispositioning Software Defects and Problem Reports (SPRs)