Director of Manufacturing Location: Warrington & Southampton, PA Reports to: Vice President, Operations

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Position Summary:

The Director of US Manufacturing is responsible for leading and optimizing production operations at our Warrington and Southampton facilities, with a focus on clean room manufacturing of components for medical devices. This role ensures operational efficiency, regulatory compliance, and alignment with strategic business goals. Key areas include team leadership, process optimization, equipment and facility oversight, and expertise in plastic/silicone extrusion and injection molding.

Key Responsibilities:

Leadership & Team Development: Lead and mentor a high-performing operations team, fostering a culture of accountability, collaboration, and continuous improvement. Production Oversight: Manage daily operations to meet production goals, KPIs, and delivery schedules within a clean room environment. Process & Quality Improvement: Drive lean initiatives, implement process improvements, and use data to enhance efficiency and product quality. Clean Room Manufacturing: Ensure compliance with environmental and regulatory standards, including cGMP, ISO 9001, 14001, and 45001. Cross-Functional Collaboration: Work closely with supply chain, quality, engineering, and R&D to align operations with organizational goals. Facility & Equipment Management: Oversee preventive maintenance, calibration, and upgrades to ensure optimal performance and compliance. Technical Expertise: Apply deep knowledge of plastic/silicone extrusion and injection molding to improve production processes and resolve technical issues. Statistical Process Control (SPC): Lead the implementation and continuous improvement of SPC across manufacturing processes.

Key Competencies:

Strategic & tactical leadership Analytical, data-driven decision-making Regulatory and quality compliance Cross-functional collaboration Innovation and process optimization

Requirements:

Bachelor’s degree in Engineering, Manufacturing, or related field (Master’s or MBA preferred) 10–15 years in operations management, including extensive medical device manufacturing experience Proven expertise in plastic/silicone extrusion and injection molding Strong background in clean room operations and regulatory compliance Demonstrated success in leading diverse teams and managing complex operations Proficiency in Lean, Six Sigma, and process improvement methodologies Strong communication and interpersonal skills Fluent in English; additional languages a plus