Director of Manufacturing & Operations

Our client is searching for a Director of Manufacturing and Operations. This person is responsible for driving excellence in our manufacturing, supply chain, and distribution. This role will be critical in ensuring our products meet the highest quality and regulatory standards while optimizing efficiency and performance. The ideal candidate will bring strong leadership skills to build high-performing teams, develop robust supply chain strategies, and oversee the successful scaling of our production capabilities. Join us to help shape the future of our company and achieve operational excellence.

Responsibilities

Direct oversight – manufacturing, supply chain, distribution, facilities, engineering

• Oversee manufacturing operations, ensuring adherence to quality standards, regulatory requirements, and production schedules.
• Develop organizational structure to support manufacturing, supply chain, distribution and engineering functions.
• Recruit talent and build high performance teams to achieve operational excellence.

Manufacturing – preparation for internal or external (OEM) manufacturing

• Provide input and oversight for the development of the US HQ facility.
• Provide input and partner with 3rd party contractor during all phases of clean room construction, validation and testing.
• Drive successful completion/support of all validation testing (IQ, OQ, PQ) and regulatory audits to ensure on time US manufacturing of CGuard Prime.
• Support all phases of design transfer to external mfg/OEM.
• Ensure on time full scale US production of CGuard Prime.

Distribution Set up

• Provide input on design, layout and operations for US HQ distribution/ warehouse facilities and supply chain

Manufacturing/ongoing

• Ensure timely and efficient manufacturing of high-quality products whether internal or outsourced mfg.
• Partner, support and provide resources to contract manufacturer.
• Ensure product demand planning is accurately converted into timely production schedule.
• Evaluate overall performance through KPIs and appropriate metrics/data.
• Define operations budget and maintain cost center compliance in accordance with budget.
• Adherence to all standards and quality systems.
• Work in compliance with and follow Company Quality Management System requirements, policies, and procedures.
• Participate in MRB/CAPA/COR/Risk assessment meetings as required.
• Collaborate in quality audits.

Supply Chain/distribution ongoing

• Oversee supply chain operations, procurement, inventory control and distribution.
• Implement robust supply chain strategies to optimize inventory management, reduce costs, and improve product availability.
• Develop and maintain Sales & Operations Planning (S&OP) process.
• Accountable for creating product demand planning and converting to production schedule.

Required Education & Experience

• Both in-house and CMO experience.
• Manage external partners and team in Israel.

For more information, please visit: https://briefs.mullingsgroup.com/position/inspiremd-director-of-manufacturing-operations/