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Principal Embedded Engineer (Medical Device)

Kutir IncWaltham, MA🇺🇸United States

Quick overview

SeniorityLeader
Work modeHybrid
LocationWaltham, MA, United States
C++Linux

Job description

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.

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