Senior Validation Engineer

Intellectt Inc is seeking experienced Verification & Validation (V&V) Engineers with expertise in the medical device industry. The selected candidate will support V&V activities throughout the product development lifecycle to ensure products meet user needs, design requirements, regulatory expectations, and quality standards.

Responsibilities:

• Plan, execute, document, and support Design Verification & Validation (V&V) activities for medical device products
• Develop and execute V&V protocols, test plans, reports, and supporting documentation in compliance with FDA requirements and internal quality systems
• 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 validation requirements
• Ensure V&V activities and associated 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 with Systems, Software, Hardware, Quality, Regulatory, and Product Development teams to integrate V&V activities throughout the product lifecycle
• 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
• Maintain accurate and timely documentation in accordance with company procedures and applicable regulations

Requirements:

• Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, or a related technical discipline, or equivalent practical experience
• 3–7 years of experience in Verification & Validation (V&V) engineering within regulated industries, preferably medical devices
• Strong experience with Design Verification & Validation activities, testing methodologies, protocols, 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 activities, validation activities, and risk controls
• Strong technical writing, documentation, and reporting skills
• Excellent verbal and written communication skills in English
• Strong analytical, organizational, and problem-solving abilities
• 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