Staff Software Engineer- Medical Device Embedded SW (Hybrid)
Role summary
Seeking an experienced Staff Software Engineer for a hybrid role focused on designing, developing, and maintaining software for safety-critical medical devices. This position requires deep expertise in embedded and application software, technical leadership, and hands-on experience in regulated medical device environments. The engineer will define software architecture, guide technical decisions, and ensure compliance with FDA and international regulations (e.g., IEC 62304, ISO 14971, 21 CFR 820). Responsibilities include leading development, ensuring software quality, participating in risk management, and collaborating with cross-functional teams. A Bachelor's degree and 4+ years of embedded systems experience are required, along with strong C/C++ and Qt/QML skills.
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)
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.