Verification & Validation Engineer - Medical Devices

Verification & Validation Engineer - Medical Devices

Capgemini

Diegem, Belgium

YOUR ROLE

As a Verification & Validation Engineer, you will play a crucial role in ensuring that medical devices meet all requirements and standards before they reach the market. You will work within cross-functional teams to plan, execute, and document verification and validation activities that are essential for regulatory compliance and product quality.

In this role you will play a key role in:

• Planning, executing, and documenting verification and validation tests based on product requirements and regulatory standards;
• Ensuring complete traceability between requirements, test cases, and results throughout the product development lifecycle;
• Applying statistical analysis and Design of Experiments (DoE) methodologies to optimize test coverage and reliability;
• Reviewing and updating V&V documentation to maintain compliance with medical device standards;
• Collaborating with R&D, Quality Assurance, and Regulatory Affairs teams to ensure product compliance with applicable regulations;
• Generating comprehensive V&V reports for internal reviews and external audits.

YOUR PROFILE

• Master Degree in Engineering, preferably Biomedical, Electronics, or related fields;
• Minimum 3 years of experience in verification and validation processes, mandatory in the medical device industry;
• Strong knowledge of medical device standards including ISO 13485, IEC 60601, and ISO 14971;
• Experience with requirements traceability and test documentation in regulated environments;
• Proficiency with Microsoft 365 suite, JIRA, and DOT (Salesforce);
• Excellent analytical and critical thinking skills with meticulous attention to detail;
• Strong communication skills with the ability to work effectively in cross-functional teams.