Staff Software Engineer- Medical Device Embedded SW (Hybrid)

Stryker • Grand Rapids, MI

1d • Hybrid

About The Position

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.

Requirements

• 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

Nice To Haves

• 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)

Responsibilities

• 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 This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees