Hired by Matrix, Inc is a certified technology solutions and compliance consulting services company, and they are seeking a Verification & Validation Engineer. The role involves planning and executing V&V activities to ensure products meet regulatory requirements, applying human factors engineering principles, and collaborating with cross-functional teams.
Responsibilities:
- Plan, execute, and document verification and validation (V&V) activities to ensure products meet functional, performance, and regulatory requirements
- Apply human factors engineering principles to product development and lead usability studies and assessments as part of V&V activities
- Develop and execute test protocols and test plans, including in vitro and in vivo testing, and analyze results to support product validation
- Maintain traceability between user needs, design inputs, and validation activities throughout the product development lifecycle
- Prepare and maintain V&V reports and documentation in compliance with regulatory requirements, including FDA expectations
- Collaborate cross-functionally with design, development, regulatory, and quality teams to integrate V&V activities into product development processes
- Identify opportunities to improve V&V processes, documentation, and testing strategies to increase efficiency, quality, and compliance
Requirements:
- 3-7 years of experience in Verification & Validation engineering within a regulated industry, preferably medical devices
- Demonstrated experience applying human factors engineering principles and conducting usability studies or assessments
- Hands-on experience developing and executing V&V protocols, test plans, and validation documentation
- Strong knowledge of FDA regulatory requirements, including V&V documentation expectations under 21 CFR Part 820
- Experience establishing and maintaining requirements traceability across user needs, design inputs, and validation activities
- Strong written and verbal communication skills in English, with the ability to produce clear technical documentation and reports
- Ability to work collaboratively in cross-functional teams while managing multiple priorities in a regulated development environment