Verification and Validation (V&V) Engineer

Key Responsibilities
• Develop and carry out verification and validation activities for medical devices in accordance with applicable standards
• Define and implement testing protocols and risk-based approaches in collaboration with engineering, quality, and regulatory teams
• Conduct validation work including biocompatibility assessments and sterilization process validation (e.g., ETO)
• Prepare technical documentation for regulatory submissions such as 510(k) and PMA
• Maintain and refine internal procedures, test methods, and documentation tools used in V&V workflows
• Ensure alignment with medical device regulatory frameworks (FDA, ISO, CE) across development stages

Required Background
• At least 5 years of hands-on experience in V&V roles within the medical technology sector
• In-depth understanding of validation testing and test method qualification
• Familiarity with regulatory guidelines including FDA requirements, ISO 13485, ISO 14971, and relevant CE marking standards
• Direct experience with biocompatibility evaluations and sterilization method validations
• History of involvement in preparing or supporting regulatory filings (510(k), EFS, PMA)

Skills and Competencies
• Analytical thinking with structured problem-solving capabilities
• Able to clearly document and communicate technical concepts
• Capable of managing multiple tasks with attention to detail and deadlines
• Strong organizational and planning abilities in regulated work environments
• Works effectively both independently and in cross-disciplinary project teams
• Self-motivated and focused on process improvement and compliance