V&V Manager

Innoventric, a developer of transcatheter heart valves, is looking for an experienced Validation & Verification (V&V) Manager to lead and oversee the V&V and laboratory activities. The role requires a strong background in V&V processes, experience in mechanical design, and a proven ability to comply with regulatory standards. As a key member of the R&D team, the V&V Manager will be responsible for driving high-quality testing, validation, and verification processes across multiple projects, ensuring that all products meet stringent safety and performance requirements.

Job Description:

·    Design, build, and maintain state-of-the-art test systems and run the mechanical laboratory.

·    Design and execute V&V protocols and test plans, ensuring compliance with regulatory requirements and industry standards (e.g., ISO, FDA).

·    Develop bench experimental systems (simulators, fatigue machines, tensile setups, etc.)

·    Develop and implement test methods and procedures to assess device performance, reliability, and safety.

·    Participate in pre-clinical in-vivo experiments - including chronic follow-up and analysis of results.

·    Take an active role in designing a cardiovascular medical device and its supportive system components.

·    Analyze test data and generate comprehensive reports detailing findings, deviations, and recommendations for improvement.

·    Prepare and maintain detailed documentation for V&V activities, including test plans, protocols, reports, and risk management files.

·    Provide technical expertise and guidance on V&V issues throughout the product development lifecycle.

Job requirements:

• Education: Bachelor’s or Master’s degree in Mechanical Engineering.
• Experience: Minimum of 5 years experience in a medical device R&D team. Strong understanding of V&V methodologies and regulatory requirements (V&V role within cardiovascular - advantage).
• Skills:
• Full control of SolidWorks.
• Proficiency in developing and executing V&V test plans and protocols.
• Experience with test equipment and statistical analysis methods.
• Strong orientation towards organized and well-documented work processes.
• Strong problem-solving skills, attention to detail, and mechanical orientation.
• Excellent communication and teamwork skills.
• Fluent in written and spoken English.

Working Environment:

• Non-hybrid, Office, and laboratory settings. Participation in pre-clinical trials. Occasional travel and participation in clinical procedures is required. Office – Rehovot/Ness Ziona science park.
• Full-time position with standard office hours. Flexibility is needed to accommodate project deadlines.

Application Process:

• Candidates who meet the job requirements are invited to send a CV to [email protected]