Validation & Verification (V&V) Engineer-Medical devices

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.

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:

biocompatibility testing (ISO 10993)

transport testing for medical products.

ISO 13485, EU MDR,

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.