Lead and manage a cross-functional site engineering team, including process engineers, validation specialists, and maintenance staff.Provide direct technical support to production, ensuring swift resolution of equipment and process issues.Actively contribute to the design, construction, and commissioning of the new U.S. production facility.Oversee equipment qualification, validation, and infrastructure readiness (HVAC, utilities, etc.).Coordinate and implement technology transfer activities from the companies primary site in Israel.Identify and manage third-party service providers for infrastructure, building, equipment, and spare parts.Drive continuous improvement in equipment reliability, production efficiency, and facility maintenance.Collaborate closely with U.S. operations and Israel-based R&D teams to align engineering practices and ensure seamless integration.Lead training and onboarding of new engineering and operations staff on transferred processes and technologies.Maintain a hands-on approach in troubleshooting, equipment setup, and site readiness activities.
7-10 years
Experience in setting up new manufacturing facilities.Familiarity with FDA and ISO 13485 standards.Prior involvement in validation protocol development and execution.
BA in Mechanical Engineering or a related technical discipline.Minimum of 7 years of engineering experience, including at least 3 years in a management role within the medical device industry.Proven expertise in scaling up manufacturing and supporting production environments.Experience working in global companies and collaborating with remote teams/stakeholders.Hands-on knowledge of technology transfer and process implementation.Project management and problem-solving skills.
Bachelors
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