Principal Software Test Engineer - Embedded Systems / Medical Devices
Principal Software Test Engineer - Embedded Systems / Medical Devices
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Job Description
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)
Bachelors 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)
Masters 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).
Required Experience:
Staff IC
Employment Type
Full-Time
