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)
Travel Percentage: 20%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.