We are seeking an experienced Validation & Verification Engineer with strong expertise in Human Factors, Design Verification & Validation, traceability, and regulatory compliance within the medical device industry.
The ideal candidate will have experience supporting V&V activities throughout the product-development lifecycle, ensuring products meet user needs, design requirements, regulatory expectations, and quality standards.
This role requires strong knowledge of FDA regulations, V&V documentation practices, and cross-functional collaboration within regulated environments.
Key Responsibilities
- Plan, execute, document, and support Design Verification & Validation activities for medical device products.
- Develop and execute V&V protocols, test plans, reports, and supporting documentation in compliance with FDA and internal quality requirements.
- Apply Human Factors Engineering principles to support usability, user safety, and product effectiveness.
- Lead or support human-factors assessments, usability studies, and validation activities.
- Establish and maintain traceability between user needs, design inputs, risk controls, verification activities, and design-validation requirements.
- Ensure all V&V activities and documentation comply with FDA 21 CFR Part 820 and applicable regulatory standards.
- Prepare and support V&V reports and related documentation for regulatory submissions, audits, inspections, and remediation activities.
- Collaborate closely with Systems, Software, Hardware, Quality, Regulatory, and Product Development teams.
- Design and execute in vitro and in vivo testing activities as required.
- Analyze test results, identify gaps or risks, and provide recommendations for product or process improvements.
- Support continuous-improvement initiatives related to V&V processes, testing methodologies, and compliance practices.
Required Qualifications
- 10+ years of experience in Verification & Validation Engineering within regulated industries, preferably medical devices.
- Strong experience with Design Verification & Validation activities, protocols, testing, and documentation.
- Experience with Human Factors Engineering and usability assessments.
- Strong understanding of FDA 21 CFR Part 820 and V&V regulatory requirements.
- Experience maintaining traceability between user needs, design inputs, verification, and validation activities.
- Strong technical-writing, documentation, and reporting skills.
- Excellent verbal and written communication skills in English.
- Strong analytical, organizational, and problem-solving abilities.
Preferred Qualifications
- Experience with biocompatibility testing and ISO 10993 requirements.
- Familiarity with sterility testing and sterilization-validation requirements for medical devices.
- Experience supporting transport testing and packaging-validation activities.
- Experience designing and executing in vitro and in vivo testing.
- Knowledge of ISO 13485, EU MDR, and other global medical-device regulations.
- Experience supporting remediation, audit-readiness, or compliance-driven initiatives.