Employment Type: Contract
Duration: 6 Months
Experience Required: 8–10 Years
Position Overview
We are seeking a Senior Verification & Validation (V&V) Engineer with experience in the medical device industry to support protocol development, test execution, validation reporting, and quality documentation. The ideal candidate will have hands-on experience with V&V activities in regulated environments, including working with legacy IT systems and technologies. This role requires strong analytical skills, attention to detail, and the ability to work independently while ensuring compliance with applicable quality and regulatory requirements.
Key Responsibilities
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Develop, review, and execute verification and validation protocols, test plans, and procedures.
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Prepare comprehensive validation reports and maintain accurate documentation of test results.
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Execute test protocols and document observations, deviations, issues, and outcomes.
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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 ensure effective validation processes.
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Work with legacy IT systems, operating environments, and technologies as required.
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Support quality processes and maintain documentation in accordance with applicable regulatory requirements.
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Analyze test results, investigate discrepancies, and assist with problem resolution.
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Ensure traceability, consistency, and accuracy of V&V documentation.
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Work independently while meeting project requirements and quality expectations.
Required Qualifications
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8–10 years of relevant professional experience in verification, validation, quality engineering, or related technical roles.
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Medical device industry experience.
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Strong experience in protocol writing, execution, and report generation.
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Hands-on experience with Verification & Validation (V&V) 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 validation 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.
PRIMARY SKILLS
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Verification & Validation (V&V)
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Medical Device Industry
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Protocol Development and Execution
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Validation Reporting and Documentation
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Quality Processes and Regulatory Compliance
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Medical Device Verification and Validation
SECONDARY SKILLS
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ISO 13485
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FDA Medical Device Regulations
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IEC 62304
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Legacy IT Systems
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Windows 2000
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Test Planning and Execution
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Deviation Documentation and Analysis
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Regulated Environments
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Quality Assurance
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IT Systems Validation
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.
