Job Title

We are seeking an experienced Validation & Verification (V&V) Engineer to join our team. This role focuses on human factors, verification and validation activities, traceability, and compliance with FDA requirements. The ideal candidate will play a crucial role in ensuring that our products meet regulatory and quality standards while aligning with user needs and design specifications.Key Responsibilities:• Apply human factors engineering principles to improve usability and ensure compliance with usability standards.• Plan, execute, and document V&V activities to verify that products meet functional, performance, and regulatory requirements.• Develop and execute test protocols, analyze results, and provide recommendations for improvement.• Maintain traceability between user needs, design inputs, and validation activities, ensuring comprehensive documentation throughout the product lifecycle.• Ensure FDA compliance (21 CFR 820) in all V&V reports and regulatory submissions.• Develop and execute in vitro and in vivo test plans in alignment with regulatory requirements.• Collaborate with design, development, and quality teams to integrate V&V activities into the product development process.• Continuously improve V&V processes to enhance efficiency and compliance.Required Qualifications:• 3-7 years of experience in V&V engineering in a regulated industry, preferably medical devices.• Strong background in human factors engineering and usability assessments.• Hands-on experience with test protocols, documentation, and compliance reporting.• In-depth knowledge of FDA regulations (21 CFR 820) and V&V reporting.• Proven ability to maintain traceability from user needs to design validation.• Excellent verbal and written communication skills in English.Preferred Qualifications:• Knowledge of biocompatibility testing (ISO 10993) and sterility requirements.• Experience with transport testing for medical products.• Familiarity with ISO 13485, EU MDR, and other global regulations.Personal Attributes:• Strong problem-solving and analytical skills.• Detail-oriented with a focus on quality and regulatory compliance.• Ability to work independently and within a team in a fast-paced environment.