Stryker

Compensation

Full Description

The Senior Software Test Engineer - Embedded Systems/Medical Devices will be responsible for leading the verification and validation (V&V) of embedded software in our Class I, II, & III medical devices. This role is critical to ensuring our products meet the highest standards of quality, safety, and regulatory compliance. The ideal candidate will bring deep expertise in embedded systems, test automation, and software testing within regulated environments (IEC 62304, ISO 13485, FDA 21 CFR Part 820) What You Will Do • Lead the software verification and test automation efforts for embedded software in medical devices. • Desing and implement automated test frameworks and test scripts for integration, system, UI, and regression testing. • Collaborate closely with software, hardware, systems, and quality teams throughout the product lifecycle. • Partner with other engineers in the development and maintenance of common test infrastructure including test fixtures, simulators, and emulators for embedded systems. • Ensure traceability of requirements to test cases in alignment with regulatory standards (IEC 62304, ISO 14971). • Participate in risk analysis, root cause investigations, and corrective/preventive actions. • Review software documentation including requirements, design, and code to ensure testability and completeness. What You Need Required Qualifications • Bachelor's degree in Computer Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, or related disciplines. • 2+ years of experience in software testing with a strong focus on embedded systems. • Experience in the development of embedded software systems and testing principles. • Knowledge of regulatory standards such as IEC 62304, ISO 13485, ISO 14971, FDA QSR. • Excellent communication, leadership, and documentation skills. • Experience with test automation. Preferred Qualifications • 2+ years in the medical device industry or similar regulated environment. • Experience with hardware/software integration testing and debugging using tools such as oscilloscopes, logic analyzers, and JTAG. • Experience with real-time operating systems (RTOS), microcontrollers, and communication protocols (e.g., CAN, I2C, SPI, UART). • Familiarity with CI/CD pipelines in embedded development environments. • Experience using requirements management and test tools (e.g., Jama, DOORS). • Experience with Python, Linux, Yocto, Qt/QML, and Squish • Certification in software testing (e.g., ISTQB, ASQ).