Principal Systems V&V Engineer

Skills Alliance; California (MO); On-site; USD 100,000 - 130,000; Full time

Job summary

A pioneering medical device start-up is seeking a talented Principal Systems V&V Engineer to join their team in California. This role involves ensuring the reliability and compliance of medical technologies, developing V&V strategies, and collaborating with cross-functional teams. The ideal candidate will have significant experience in the medical device industry and strong skills in automated testing. This is a full-time on-site position in Irvine, CA.

Qualifications

• 9+ years of experience in V&V, ideally in the medical device industry.
• Strong knowledge of FDA 21 CFR Part 11 and ISO standards.
• Experience with hardware/software integration and communication protocols.

Responsibilities

• Develop and execute V&V test protocols for Class II/III medical devices.
• Design and maintain automated test frameworks.
• Collaborate with cross-functional teams to ensure test coverage.

Skills

Verification and validation test protocols

Test automation frameworks

FDA standards compliance

Embedded systems testing

Education

Bachelor's or Master's degree in relevant field

Tools

Python

LabVIEW

C/C++

Job description

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