Principal Embedded Software Engineer

Job Details: Job Location: RALEIGH

• RALEIGH, NC, Position Type: Full Time, Salary Range: Undisclosed, Position Summary: We are seeking a highly experienced Principal Embedded Software Engineer to lead the design and development of embedded software for medical device systems. This role focuses on delivering safe, reliable, and high-performance software in compliance with regulatory standards, including ISO 62304. As a key member of our R&D organization, you will translate system requirements into robust embedded software solutions, partnering closely with cross-functional engineering and quality teams. Your work will directly support new product development, design transfer, and lifecycle maintenance of regulated medical devices, ensuring quality, safety, and performance. Duties & Responsibilities: Lead embedded software development activities across the full medical device lifecycle in accordance with ISO 62304. Collaborate with hardware, systems, and quality engineering teams to define system architecture, software requirements, and design specifications. Design, develop, and maintain embedded software primarily in C and C++ for microcontroller and processor-based systems. Participate in requirements definition, risk analysis, and traceability to ensure compliance with regulatory standards. Develop and execute software verification and validation activities, including unit testing, integration testing, and system-level testing. Support design reviews and ensure adherence to design control processes. Contribute to software documentation, including requirements, architecture, design, and test artifacts. Support new product introduction (NPI), design transfer, and sustaining engineering activities. Troubleshoot and resolve software defects across development and production environments. Ensure compliance with applicable regulatory and quality standards through structured development and documentation practices. Other duties as needed or required.

Qualifications

Minimum Requirements & Qualifications: Bachelor’s or Master’s degree in Electrical Engineering, Computer Science, or a related field, with 12+ years of experience in embedded software development. Strong experience in medical device software development compliant with ISO 62304. Deep expertise in embedded systems, microprocessor-based controller design and fault finding and resolution.

Advanced proficiency in C and C++ for embedded applications. Experience with real-time operating systems (RTOS) and/or bare-metal development. Strong ability to read and interpret electronic schematics and component datasheets. Experience with software verification and validation methodologies in regulated environments.

Familiarity with risk management processes (e.g., ISO 14971) and design control practices. Experience working in cross-functional teams including hardware, systems, quality, and manufacturing engineering. Proficiency with debugging tools, version control systems, and embedded development toolchains. Experience supporting product lifecycle activities, including sustaining engineering and post-market support.

Preferred Qualifications

Serial communications RS422, SPI, I2C. Closed loop controller (PID) design. Wireless communication (Wi-Fi and cellular). Data encryption. OTA software updates. Embedded graphics development with Qt, LVGL or other framework.