Senior Verification & Validation (V&V) Engineer

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

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.

• 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.

• 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.

• 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.