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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 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.
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 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
ya**@in*********.com