Principal Embedded Software Engineer

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.