Validation & Verification Engineer

Company Overview

Intellectt combines advanced technology, domain knowledge, and innovation to deliver excellence. As a fast-growing provider of engineering, IT, and consulting services in the US, Intellectt specializes in sectors like manufacturing, medical devices, healthcare, banking, and financial services. They leverage emerging technologies such as Artificial Intelligence, NLP, Blockchain, and Cloud to help clients navigate complex technology and business challenges.

Role Summary

We are looking to hire a seasoned Validation & Verification Engineer with in-depth experience in human factors, design verification and validation (V&V), traceability, and adhering to regulatory standards within the medical device industry. The candidate will be responsible for supporting V&V tasks throughout the full product development lifecycle to ensure compliance with user needs, design requirements, quality criteria, and regulatory mandates.

Key Responsibilities

• Plan, execute, and document design verification and validation activities for medical device products.
• Create and implement V&V protocols, test plans, reports, and documentation following FDA and internal quality standards.
• Use Human Factors Engineering principles to improve usability, user safety, and product performance.
• Lead or assist with human factors evaluations, usability testing, and validation exercises.
• Maintain traceability linking user needs, design inputs, risk mitigations, verification tasks, and validation criteria.
• Ensure full compliance with FDA 21 CFR Part 820 and other relevant regulatory guidelines for all V&V activities and documents.
• Prepare materials supporting regulatory submissions, audits, inspections, and remedial actions.
• Collaborate closely with cross-functional teams including Systems, Software, Hardware, Quality, Regulatory, and Product Development.
• Design and conduct in vitro and in vivo tests as necessary.
• Analyze outcomes of testing, identify issues or risks, and suggest improvements to product or processes.
• Contribute to continuous improvement efforts in V&V processes, testing approaches, and compliance practices.

Required Qualifications

• Minimum of 10 years’ experience in Verification & Validation Engineering specifically within regulated medical device industries.
• Proven expertise in performing Design Verification and Validation, including protocol development, testing, and comprehensive documentation.
• Experience applying Human Factors Engineering concepts and conducting usability assessments.
• Strong knowledge of FDA regulations, particularly 21 CFR Part 820, and overall V&V regulatory frameworks.
• Demonstrated ability to maintain traceability between user needs, design inputs, and V&V activities.
• Excellent technical writing, documentation, and report generation skills.
• Fluency in English with effective verbal and written communication abilities.
• Exceptional analytical, organizational, and problem-solving skills.

Preferred Qualifications

• Familiarity with biocompatibility testing and ISO 10993 standards.
• Knowledge of sterility testing and sterilization validation protocols.
• Experience in transport testing and packaging validation for medical devices.
• Capability in designing and executing in vitro and in vivo testing activities.
• Understanding of ISO 13485, EU Medical Device Regulation (MDR), and other international medical device regulatory requirements.
• Experience supporting remediation, audit readiness, or compliance-driven projects.

Eligibility

Candidates applying should be Any Graduate or possess B.Tech/B.E. degrees in Mechanical Engineering, Medical Electronics, Mechatronics, or Manufacturing Engineering.

Location

Position is based in Chennai, India and requires onsite presence.