Validation & Verification Engineer Work Schedule: Must be available to work during US EST/CST business hours
Employment Type: Full-Time

Job Overview
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 idóneo 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 practic

📌 Validation Engineering (México)
🏢 Intellectt
📍 México