We are seeking a highly experienced Staff Software Engineer to help design, develop, and maintain software for safety-critical medical devices. This role requires deep technical expertise in embedded and application software, strong technical leadership, and hands-on experience developing software in regulated medical device environments.

You will play a key role in defining software architecture, guiding technical decisions, and ensuring compliance with applicable FDA and international medical device regulations and standards, while remaining actively involved in development.

What You Will Do

• Lead the design, implementation, and testing of medical device software in compliance with regulatory standards

• Develop high-quality, maintainable software using C, C++, Linux, and Qt/QML

• Ensure software development activities comply with IEC 62304 (Medical Device Software – Software Life Cycle Processes)

• Participate in and support risk management activities in accordance with ISO 14971, including hazard analysis and risk controls related to software

• Contribute to system-level requirements, software requirements, and traceability between requirements, design, implementation, and verification artifacts

• Collaborate with Quality, Regulatory, Systems Engineering, and Hardware teams to support FDA design controls (21 CFR 820 / Quality System Regulation)

• Support software verification and validation activities, including test planning, execution, and documentation

• Participate in design reviews, code reviews, and technical risk assessments

• Mentor engineers and establish best practices for compliant software development, documentation, and review processes

What You Need (Required Qualifications)

• Bachelor's degree in Computer Engineering, Computer Science, Electrical Engineering or related disciplines

• 4+ years of experience in software engineering, with experience with embedded systems

• Extensive professional experience in software engineering with demonstrated staff-level technical leadership

• Strong proficiency in C and C++ for embedded and system-level software

• Hands-on experience with Qt and QML for application and user interface development

• Experience working within a regulated development environment requiring formal documentation, reviews, and traceability

Preferred Qualifications

• Experience with Real-Time Operating Systems (RTOS)

• Knowledge of embedded and medical device communication protocols (e.g., UART, SPI, I²C, Ethernet, USB, CAN)

• Experience implementing and maintaining CI/CD pipelines in regulated or embedded development environments

• Experience with test automation, including unit, integration, and system testing

• Familiarity with:

  • FDA Design Controls and submissions support (e.g., 510(k), PMA)

  • IEC 60601 considerations as they relate to software

  • Cybersecurity guidance for medical devices (e.g., FDA premarket cybersecurity guidance)