Grand Rapids, MI, 49507, USA
15 hours ago
Principal Software Test Engineer - Embedded Systems / Medical Devices
The **Principal 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 design, development, and execution of test strategies and plans for embedded software in medical devices. + Architect and implement automated test frameworks and test scripts for unit, integration, system, and regression testing. + Collaborate closely with software, hardware, systems, and quality teams throughout the product lifecycle. + Develop and maintain 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). + Mentor junior and mid-level test engineers in best practices, test design, and technical execution. + 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** **Minimum Qualifications (Required Qualifications)** + Bachelor's degree in Computer Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, or related disciplines. + 8+ years of experience in software testing with a strong focus on **embedded systems.** + 5+ years in the **medical device** industry or similarly regulated environment. + Deep understanding of embedded software development and testing principles. + Strong knowledge of regulatory standards such as **IEC 62304** , **ISO 13485** , **ISO 14971** , **FDA QSR** . + Experience with hardware/software integration testing and debugging using tools such as oscilloscopes, logic analyzers, and JTAG. + Excellent communication, leadership, and documentation skills. **Preferred Qualifications (Strongly desired)** + Master's degree in Computer Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, or related disciplines & 6+ years of work experience. + 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 Linux, Yocto, Qt/QML, and Squish. + Certification in software testing (e.g., ISTQB, ASQ). 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. 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.
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