Senior Verification & Validation (V&V) Engineer - Medical Devices

Industry: Medical Devices

Key Skills: Verification & Validation (V&V), Protocol Development, Test Execution, Validation Reporting, ISO 13485, FDA Regulations, IEC 62304

Job Summary

We are seeking a Senior Verification & Validation (V&V) Engineer with medical device industry experience to develop, execute, and document verification and validation protocols in a regulated environment. The ideal candidate will have strong IT systems experience, the ability to work with legacy technologies, and a disciplined approach to quality documentation and regulatory compliance.

Key Responsibilities

• Develop, review, and execute V&V protocols, test plans, and test procedures.

• Perform protocol execution and document test results, observations, deviations, and outcomes accurately.

• Prepare comprehensive verification and validation reports in accordance with established procedures.

• Support V&V activities throughout the medical device product lifecycle.

• Work with legacy IT systems and technologies, including Windows 2000, where required.

• Investigate test failures, analyze discrepancies, and support root-cause analysis and resolution.

• Maintain traceable documentation and ensure adherence to approved protocols and quality procedures.

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

• Support audits and compliance activities by maintaining complete and accurate validation records.

• Ensure V&V deliverables meet applicable regulatory and quality requirements.

Required Technical Skills

• 8-10 years of relevant experience in verification, validation, or testing, preferably within the medical device industry.

• Strong hands-on experience in protocol writing, execution, and report generation.

• Practical experience with V&V activities in a regulated environment.

• IT systems knowledge and the ability to work with legacy operating systems and technologies.

• Experience documenting test evidence, deviations, observations, and validation outcomes.

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

• Excellent written and verbal communication skills.

• Ability to work independently with minimal supervision.

Preferred Qualifications

• Familiarity with FDA requirements and medical device quality regulations.

• Knowledge of ISO 13485 quality management systems.

• Familiarity with IEC 62304 medical device software lifecycle processes.

• Experience supporting regulated product development, quality documentation, and compliance activities.