Senior Verification & Validation (V&V) Engineer

Job Description: Senior Verification & Validation (V&V) Engineer

• Location: Milpitas, California

• Duration: 6 months

• Experience Required: 8–10 years

• Job Title: Senior V&V Engineer

• Industry: Medical Devices

• Primary Skills: Verification & Validation (V&V), Protocol Development, Test Execution, Validation Reporting

• Regulatory Standards: ISO 13485, FDA regulations, IEC 62304

• Skill Category: Medical Device and Regulations

Must-Have Technical/Functional Skills

• Medical device industry experience.

• Strong experience in protocol writing, review, execution, and report generation.

• Hands-on experience with Verification & Validation (V&V) activities.

• IT systems experience.

• Experience working with legacy operating systems, particularly Windows 2000.

• Ability to work with legacy technologies and systems.

• Knowledge of regulated environments and quality processes.

• Experience developing and executing test plans and validation protocols.

• Strong analytical, troubleshooting, and problem-solving skills.

• Excellent written and verbal communication skills.

• Ability to work independently with minimal supervision.

• Familiarity with FDA regulations, ISO 13485, and IEC 62304 standards is a plus.

Roles and Responsibilities

1. Verification and Validation (V&V)

• Develop, review, and execute Verification and Validation protocols and test plans.

• Perform hands-on verification and validation activities throughout the product lifecycle.

• Ensure testing activities meet established requirements and acceptance criteria.

• Support product verification, software validation, and system validation activities as applicable.

• Identify test failures, discrepancies, and unexpected results.

• Ensure V&V activities are performed in accordance with approved procedures.

2. Protocol Development and Execution

• Develop detailed test protocols and validation plans.

• Review protocols to ensure completeness, accuracy, and compliance with applicable requirements.

• Execute test protocols according to approved procedures.

• Document observations, test results, deviations, and outcomes accurately.

• Investigate unexpected results and support resolution of testing issues.

• Maintain traceability between requirements, test cases, and test results.

3. Validation Reporting and Documentation

• Prepare validation reports and technical documentation.

• Ensure test results are documented accurately and consistently.

• Maintain complete and traceable V&V records.

• Document deviations, discrepancies, and corrective actions as required.

• Review test documentation for completeness and compliance.

• Follow Good Documentation Practices (GDP) and applicable quality procedures.

4. Legacy Systems and IT Infrastructure

• Work with legacy systems and technologies as required for testing and validation.

• Support testing activities involving legacy operating systems, particularly Windows 2000.

• Assess legacy system functionality and compatibility with established requirements.

• Troubleshoot issues related to legacy IT systems and testing environments.

• Maintain system configurations and document relevant testing conditions.

• Support validation activities involving legacy medical device software or IT systems, as applicable.

5. Regulatory Compliance and Quality Management

• Ensure V&V activities comply with applicable quality and regulatory requirements.

• Follow established quality management system procedures.

• Apply relevant FDA requirements and ISO 13485 standards.

• Understand IEC 62304 requirements where software lifecycle activities are involved.

• Maintain audit-ready documentation and validation records.

• Support quality investigations and compliance-related activities.

6. Cross-Functional Collaboration

• Collaborate with Engineering, Quality Assurance, and Regulatory Affairs teams.

• Coordinate testing activities and communicate progress, risks, and issues.

• Work with technical teams to resolve testing failures and system issues.

• Review requirements and clarify testing expectations with stakeholders.

• Support cross-functional reviews of protocols, test results, and validation reports.

7. Independent Execution and Problem-Solving

• Manage V&V assignments independently with minimal supervision.

• Analyze complex technical problems and identify appropriate solutions.

• Investigate deviations and unexpected test results.

• Prioritize testing activities and meet project timelines.

• Communicate technical findings clearly to stakeholders.

• Contribute to continuous improvement of validation processes and documentation.

Key Skills and Keywords for Resume Search

• Senior V&V Engineer

• Verification and Validation Engineer

• Medical Device Industry

• Medical Device Software Validation

• Verification and Validation (V&V)

• Protocol Development

• Protocol Writing

• Protocol Execution

• Test Plan Development

• Test Execution

• Validation Report Writing

• Validation Documentation

• Software Validation

• System Validation

• IT Systems Validation

• Legacy Systems

• Windows 2000

• Regulated Environment

• FDA Regulations

• ISO 13485

• IEC 62304

• Quality Management System (QMS)

• Good Documentation Practices (GDP)

• Requirements Traceability

• Deviation Management

• Test Results Analysis

• Root-Cause Analysis

• Medical Device Compliance

• Engineering and Quality Collaboration

Pre-Screening Questions

• Do you have 8–10 years of experience in Verification and Validation?

• Do you have prior experience in the medical device industry?

• Have you developed, reviewed, and executed V&V protocols and test plans?

• Do you have hands-on experience preparing validation reports and documenting test results?

• Have you worked in a regulated environment with established quality processes?

• Do you have experience with legacy operating systems, particularly Windows 2000?

• Have you performed IT system or software validation activities?

• Are you familiar with FDA requirements and ISO 13485?

• Do you have knowledge of IEC 62304 software lifecycle processes?

• Have you documented test deviations, investigated failures, and maintained traceability records?

• Can you independently manage testing assignments with minimal supervision?

• Are you comfortable collaborating with Engineering, Quality, and Regulatory Affairs teams?

Ideal Candidate Profile

• Senior V&V Engineer with 8–10 years of relevant experience, preferably in the medical device industry.

• Strong hands-on experience writing, executing, and documenting verification and validation protocols.

• Proven ability to prepare validation reports and maintain accurate, traceable testing records.

• Experience working with legacy IT systems, particularly Windows 2000.

• Knowledge of regulated environments, quality management processes, and applicable medical device standards.

• Familiarity with FDA regulations, ISO 13485, and IEC 62304.

• Strong analytical, documentation, and problem-solving skills.

• Ability to work independently while coordinating effectively with engineering, quality, and regulatory teams.