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.
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.