Location: Milpitas, CA
Work Arrangement: Fully Onsite
Employment Type: Contract
Duration: 7 months
Experience Required: 8–10 years
Position Overview
We are seeking a Senior Verification & Validation (V&V) Engineer with medical device industry experience to develop, execute, and document verification and validation activities in a regulated environment. The successful candidate will lead protocol development, test execution, and validation reporting while supporting product quality and compliance throughout the product lifecycle. This role requires hands-on experience with legacy systems, strong technical documentation skills, and the ability to work independently.
Primary Skills
Verification & Validation (V&V)
Medical Device Industry
Protocol Development and Execution
Validation Reporting
IT Systems
ISO 13485
Secondary Skills
Legacy Operating Systems
Windows 2000
Test Plans and Test Protocols
Quality Management Systems
FDA Regulations
IEC 62304
Regulatory Compliance
Deviation Documentation
Key Responsibilities
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Develop, review, and execute verification and validation protocols and test plans.
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Prepare validation reports and ensure accurate, complete documentation of test results.
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Execute test protocols and document observations, deviations, outcomes, and supporting evidence.
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Support verification and validation activities throughout the medical device product lifecycle.
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Collaborate with Engineering, Quality, and Regulatory Affairs teams to support product quality and compliance.
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Work with legacy systems and technologies, including older operating systems such as Windows 2000, as required.
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Ensure V&V documentation and activities align with applicable quality procedures and regulatory requirements.
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Analyze test results, investigate issues, and support resolution of identified discrepancies.
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Maintain clear and traceable technical documentation in a regulated environment.
Required Qualifications
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8–10 years of relevant professional experience.
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Experience working in the medical device industry.
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Strong hands-on experience in protocol writing, execution, and report generation.
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Practical experience with verification and validation activities.
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Experience working with IT systems and legacy technologies.
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Exposure to legacy operating systems, particularly Windows 2000.
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Understanding of regulated environments, quality processes, and controlled documentation.
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Strong analytical, troubleshooting, and problem-solving skills.
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Excellent written and verbal communication skills.
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Ability to work independently with minimal supervision.
Preferred Qualifications
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Bachelor's or Master's degree in Biomedical Engineering, Computer Science, Information Technology, Electronics Engineering, Software Engineering, Life Sciences, or a related field.
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Familiarity with FDA requirements, ISO 13485, and IEC 62304.
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Experience supporting quality and regulatory compliance activities within medical device development.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, and gender identity), national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
We are committed to providing reasonable accommodations to qualified applicants with disabilities and for sincerely held religious beliefs, as required by applicable law. Applicants who require a reasonable accommodation during the hiring process may request assistance.
Employment may be contingent upon the successful completion of job-related pre-employment screening, which may include background and reference checks and, where permitted by applicable law and applicable to the position, drug testing. All such screening will be conducted in accordance with applicable federal, state, and local laws.
