About this role

Principal Embedded Engineer (Medical Device)
Location: Waltham, MA (Hybrid)
Experience: 10 15+ Years

Key Requirements:

Strong hands-on experience in Embedded C/C++, Embedded Linux, and RTOS.
Expertise in firmware development, device drivers, hardware-software integration, and multithreading.
Experience with UART, SPI, I C, CAN, USB, and embedded debugging tools.
Strong embedded software architecture, troubleshooting, and technical leadership skills.
Experience in medical devices or other safety-critical regulated industries (Aerospace, Automotive, Defense, etc.).
Knowledge of IEC 62304, ISO 13485, ISO 14971, FDA regulations, and Design History File (DHF) documentation.
Experience with software verification, validation, risk management, and requirements traceability.
Ability to lead complex embedded development and legacy code remediation.

Preferred: Point-of-care diagnostic or IVD medical-device experience.

Note: Candidates from safety-critical regulated industries are welcome even without direct medical-device experience.

Principal Embedded Engineer (Medical Device)

Key skills