A pioneering medical device start-up whose mission is to transform patient care through innovation, precision, and collaboration are seeking a talented and driven Principal Systems V&V Engineer to join their growing team in California.
The Principal Systems V&V Engineer will play a critical role in ensuring the reliability, safety, and compliance of their technologies. You will develop and execute verification and validation strategies, design test automation frameworks, and collaborate closely with R&D, systems engineering, and quality teams to support product development from concept to commercialization.
Responsibilities:
- Develop and execute verification and validation (V&V) test protocols for Class II/III medical devices in compliance with FDA and ISO standards.
- Design, build, and maintain automated test frameworks for hardware, software, and system-level testing.
- Perform functional, regression, integration, and system testing of embedded systems and software.
- Analyze test data, generate detailed test reports, and document results to support regulatory submissions.
- Collaborate with cross-functional teams (engineering, quality, regulatory, and clinical) to identify risks, define requirements, and ensure test coverage.
- Support risk management activities (e.g., FMEA, hazard analysis) by providing verification input.
- Troubleshoot issues, root-cause failures, and work with engineers to resolve them.
- Ensure test equipment and automation tools are qualified, calibrated, and compliant with internal and external standards.
Requirements:
- Bachelor’s or Master’s degree in Electrical Engineering, Computer Engineering, Biomedical Engineering, or related field.
- 9+ years of experience in V&V, test engineering, or automation, ideally in the medical device industry.
- Strong knowledge of FDA 21 CFR Part 11, ISO 13485, IEC 60601, and ISO 14971.
- Proficiency in developing automated test scripts and tools (Python, LabVIEW, C/C++, or similar).
- Experience testing embedded systems, hardware/software integration, and communication protocols (e.g., SPI, I2C, UART, BLE).
- Excellent analytical, problem-solving, and documentation skills.
- Experience with neuromodulation, implantable medical devices, or Class III medical systems.
- Familiarity with Model-Based Design and system-level testing (e.g., MATLAB/Simulink).
- Hands-on experience with oscilloscopes, logic analyzers, and other electronic test equipment.
- Experience supporting regulatory submissions (510(k), PMA).
Location: Irvine, CA (On-site)
Company: Medical Device
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Quality Assurance, Engineering, and Research
Industries: Medical Equipment Manufacturing
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