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 adecuado 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

- 15+ 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.

📌 Validation & verification engineer (Xico)
🏢 Intellectt
📍 Xico