Verification And Validation Engineer
CurrentRole Overview:As a Verification and Validation (V&V) Engineer at a medical equipment manufacturing company, I play a crucial role in ensuring that medical devices and systems meet regulatory, safety, and performance standards before they are released to the market. My responsibilities involve rigorous testing and validation procedures to verify that equipment performs as intended and complies with industry norms.Key Responsibilities:Test Plan Development:• Collaborate with design and engineering teams to understand product functionality and performance criteria.• Assist in creating detailed verification and validation plans, protocols, and procedures based on product requirements.Testing Execution:• Conduct hands-on testing of medical devices, including functional, performance, reliability, and safety tests.• Utilize specialized testing equipment and software to gather data.Data Analysis and Reporting:• Analyse test results to identify discrepancies or non-conformities.• Prepare clear and concise reports for senior engineers and management.• Assist in creating test summaries and technical reports for regulatory submissions.Compliance and Quality Assurance:• Ensure testing activities comply with relevant regulatory standards (e.g., FDA, ISO) and internal quality management systems.• Participate in audits and inspections.Problem Solving and Troubleshooting:• Identify root causes of issues detected during testing.• Collaborate with cross-functional teams to resolve issues.• Propose corrective and preventive actions to enhance product quality and reliability.Continuous Improvement:• Contribute to ongoing improvements in V&V processes, tools, and methodologies.• Stay updated on industry trends, standards, and technologies related to medical device verification and validation.Technical Skills:• Basic understanding of medical device regulations and standards (e.g., FDA, ISO 13485, IEC 60601 Series).
