Sr Engineering Manager (Injection molding)

Main Functions and Responsibilities

• Engineering Strategy and Leadership
• Define and execute the engineering strategy aligned with site and division objectives.
• Lead and develop the engineering team, promoting a high-performance, continuous improvement, and compliance culture.
• Manage the Engineering budget, including planning and CAPEX justification for projects and expansions.
• Projects, Expansions, and Sustainability
• Lead capital projects related to new molding lines, capacity expansion, automation, and process optimization.
• Ensure projects consider sustainability principles, energy efficiency, waste reduction, and responsible resource use.
• Coordinate layout planning, process flows, and line balancing with Production and Pipette Molding.
• Engineering Changes and Releases
• Ensure proper management of engineering changes (ECR/ECO), assessing impact on quality, validation, cost, and capacity.
• Approve and release engineering changes per quality system procedures and regulatory requirements.
• Validations and Regulatory Compliance
• Own the development, execution, and maintenance of the Validation Master Plan.
• Lead validations of new products, processes, and equipment (IQ/OQ/PQ), as well as periodic revalidations.
• Ensure compliance with ISO 13485, ISO 9001, and other applicable medical device regulatory requirements.
• New Products and Customer Requirements
• Lead New Product Introduction (NPI), ensuring robust transfer from design to manufacturing.
• Ensure customer specifications are correctly interpreted, documented, and implemented in molding and assembly processes.
• Coordinate with Quality, Production, Supply Chain, and Maintenance to guarantee successful, stable launches.
• Interaction with Pipette Molding and Tool Room
• Collaborate with the Tool Room on mold design, engineering changes, new developments, and improvements, acting as a technical and strategic liaison, with no direct operational responsibility.