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.