Principal Software Test Engineer - Embedded Systems / Medical Devices

Work Flexibility: Hybrid or Onsite

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).

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.