Manager, Manufacturing Operations - Medical Device - Marlborough, MA

IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. Headquartered in Marlborough, MA, we aspire to work together with our employees and customers to apply light in ways that improve life.

Our mission is to develop innovative medical device laser solutions that make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged, diverse, and thriving workforce that drives a sustainable future for our company and society.

Working at IPG Medical Group you can expect challenging projects, a motivating and friendly environment, and competitive benefits.

Responsibilities:

• Manage day-to-day operations of manufacturing operations including production, depot service, shipping/receiving, supply chain, material control, and packaging of capital equipment and consumable devices.
• Manage manufacturing inventory, including cycle counting and reconciliation of any transactions or count discrepancies.
• Design and implement multiple work cell production lines with the emphasis on Lean Manufacturing to meet increased production volume and improve efficiency.
• Develop and drive master production schedule based on sales orders and forecast, including plan for material requirements and purchase.
• Participate in product development projects as manufacturing representative from design input to verification, validation and design transfer stages, following all applicable medical product quality system standards and regulations.
• Manage Manufacturing Engineering to support sustaining manufacturing and new product introduction; when necessary, perform essential Manufacturing Engineering functions, such as, development of assembly/fabrication drawings and manufacturing procedures, and manufacturing equipment IQ/OQ/PQ.
• Represent Manufacturing in Quality and Regulatory functions, including CAPA program, Complaint Handling, and MRB.

Education requirements

• B.S. Engineering or similar discipline

Experience requirements

• 15+ years of work experience in manufacturing and service of light-based medical products in a cGMP environment, with more than 5 years in managing positions.
• Strong working knowledge of ISO13485, QSR 21 CFR 820, and other medical standards.

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