R&D & V&V Project Manager

In this role, you will lead the planning, development, and testing activities for the company’s products, ensuring full compliance with regulatory requirements and applicable standards. The position combines hands-on laboratory work with day-to-day team leadership and cross-functional project management.

Key Responsibilities
- Manage design and development activities across multiple aspects of the company’s products.
- Ensure compliance with regulatory requirements and relevant standards throughout the lifecycle.
- Lead and manage verification & validation (V&V) activities, including bench/lab testing for mechanical and clinical aspects.
- Define roles, responsibilities, and objectives for team members while maintaining hands-on involvement in R&D.
- Lead, manage, and coordinate projects with internal departments and external consultants.
- Serve as design & development project manager across: Design Control; device/process improvements/changes; integration of technical and clinical considerations; analyses and investigations of human and animal procedures.
- Generate mechanical requirements and specifications; assume full responsibility for laboratory operations.
- Support DHF and DMR documentation through transfer to production.
- Conduct risk analyses and drive risk management activities in accordance with company policy and recognized methodologies (e.g., ISO 14971).
- Perform failure analyses during development and conduct periodic design reviews.
- Lead Human Factors & Usability processes as part of product development (e.g., IEC 62366).
- Execute acceptance/verification testing under defined conditions, in accordance with safety guidelines.
- Perform integration and verification testing for R&D-stage products.
- Develop test methods to support development and prototype assembly.
- Maintain accurate, complete records of all test data and results (paper and electronic) per company procedures.
- Lead R&D studies, activities, and projects as assigned by departmental needs.
דרישות התפקיד
- B.Sc. in Mechanical Engineering (required); advanced degree is an advantage.
- At least 5 years of experience in the medical device industry (required).
- Hands-on laboratory experience (required).
- Proficiency with CAD tools (e.g., SolidWorks) (required).
- Familiarity/experience with LabVIEW (advantage).
- Prior experience leading cross-functional teams and working in regulated environments (e.g., ISO 13485 / IEC 62366).
- Experience with V&V testing for products involving mechanics/electronics/clinical use (advantage).