Verification and Validation (V&V) Engineer

Position Overview:

We are seeking a highly motivated and experienced Verification and Validation (V&V) Engineer to join our team

The ideal candidate will have a strong background in software testing and quality assurance within the medical device industry.

This role is critical to ensuring compliance with regulatory standards and delivering high-quality, reliable products to market.

Key Responsibilities:

Verification and Validation Activities:

• Design, develop, and execute software test plans, protocols, and test cases in compliance with regulatory requirements (e.g., FDA, ISO 13485)
• Perform functional, integration, system, and regression testing for medical device software.
• Collaborate with cross-functional teams to ensure software meets design and user requirements.

Documentation:

• Create and maintain comprehensive V&V documentation, including traceability matrices, test reports, and defect logs, ensuring compliance with QMS and regulatory standards.
• Review and approve test plans, protocols, and other related documentation.

Quality Assurance:

• Support risk management activities ensuring risks are adequately addressed in the testing process.
• Conduct defect tracking and resolution activities, working closely with software developers.

Regulatory Compliance:

• Support regulatory submissions and audits as needed by providing test data and documentation.

Qualifications and Skills:

Education and Experience:

• Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or a related field.
• 3+ years of experience in V&V engineering, specifically in the medical device industry.

Technical Skills:

• Strong understanding of software development life cycles (SDLC) and software quality assurance processes.
• Hands-on experience with testing tools, automation frameworks, and bug tracking systems.

Regulatory Knowledge:

• Deep knowledge of medical device regulations and standards, including ISO 13485, IEC 62304, and FDA guidelines.
• Experience with regulatory audits and submission processes is preferred.

Soft Skills:

• Excellent analytical and problem-solving skills.
• Strong communication and interpersonal skills for collaboration with cross-functional teams.
• Detail-oriented and highly organized with the ability to manage multiple tasks and deadlines.

Please send CV to Sagi Peled at [email protected]