Verification Validation Engineer

QvalFocus Inc. is seeking a Verification Validation Engineer with strong experience in verification and validation activities for medical devices. The role involves planning, executing, and documenting validation work while ensuring compliance with regulatory requirements and alignment with user needs and design inputs.

Responsibilities:

• Plan, execute, and document verification and validation (V&V) activities for medical device products
• Develop and execute test protocols, test plans, and validation reports for product requirements, performance, and regulatory compliance
• Ensure complete traceability between user needs, design inputs, verification, and validation activities throughout the product lifecycle
• Apply human factors engineering principles and support / lead human factors assessments and usability studies as part of validation work
• Prepare and maintain FDA-compliant V&V documentation and reports in line with 21 CFR Part 820 requirements
• Support preparation of validation records and documentation required for regulatory submissions, audits, and inspections
• Work closely with design, development, quality, and regulatory teams to ensure V&V activities are aligned with overall product development needs
• Design and execute in vitro and in vivo test plans where applicable, ensuring scientifically sound and compliant test execution
• Analyze validation results, identify gaps or failures, and provide recommendations for product or process improvement
• Contribute to continuous improvement of validation processes to improve efficiency, accuracy, and compliance

Requirements:

• 7+ years of experience in V&V engineering within a regulated industry, preferably medical devices
• Strong experience with verification and validation activities, including protocol writing, execution, and reporting
• Hands-on exposure to human factors / usability engineering activities
• Strong understanding of FDA 21 CFR Part 820, especially around validation documentation and reporting
• Proven experience with traceability from user needs → design inputs → validation
• Strong technical writing and documentation skills
• Good communication skills and ability to work cross-functionally
• Strong verbal and written English communication