Validation & Verification Engineer

Tekone It Services; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

Tekone It Services is seeking an experienced Validation & Verification Engineer with expertise in Human Factors, design verification & validation, traceability, and regulatory compliance within the medical device industry.

You will support V&V activities throughout the product-development lifecycle, ensuring products meet user needs, design requirements, regulatory expectations, and quality standards. Strong knowledge of FDA regulations and V&V documentation practices is required.

Qualifications

• 10+ years of Verification & Validation Engineering experience in regulated industries, preferably medical devices.
• Strong experience with V&V 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 in English.
• Strong analytical, organizational, and problem-solving abilities.

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.

Skills

Verification & Validation

Human Factors

Regulatory compliance

Documentation

Cross-functional collaboration

Technical writing

Communication (English)

Analytical thinking

Job description

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 ideal 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

• 10+ 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.