Fda-regulated class ii/iii medical device experience
Iec-62304 compliance knowledge
The Principal Software Test Engineer will lead the development and execution of manual and automated software test activities for life-saving organ preservation technology
Job Summary
The Principal Software Test Engineer will lead the development and execution of manual and automated software test activities for life-saving organ preservation technology.
This role requires ensuring compliance with FDA guidelines and IEC-62304 standards while managing requirements traceability for medical device embedded software.
TransMedics offers a comprehensive benefits package including medical, dental, vision, 401K, and equity opportunities to support employees in their mission to save lives.
Matching Summary
The Principal Software Test Engineer will lead the development and execution of manual and automated software test activities for life-saving organ preservation technology.
Salary
Base: $151,500.00 – $215,700.00; Bonus/Equity: Eligible for bonuses and equity; Benefits: Medical, dental, vision, 401K, PTO, wellness resources
Skills & Requirements
Must-have
10+ years real-time embedded software testing
FDA-regulated Class II/III medical device experience
IEC-62304 compliance knowledge
Manual and automated test execution
Test strategy and protocol development
Nice-to-have
Bluetooth/BLE and Cloud-connected device testing
Agile development environment experience
Requirements and defect management tools
FMEA and Design Review participation
External systems integration testing
Key Requirements
BS/MS in Software or Electrical Engineering
10+ years related experience in embedded software testing