Director, US Manufacturing

Description

Position Summary:

The Director, US Manufacturing will oversee and optimize operational activities to ensure efficiency, quality and alignment with the strategic goals for our Warrington and Southampton, PA locations. This role will focus on component production in a clean room environment. Reporting to the Vice President, Operations, this role is responsible for team leadership, process optimization and production management. Must have experience leading production under cGMP, ISO 9001,14001 and 45001 standards. The Director will drive operational excellence, maintain facilities and equipment, and leverage a deep understanding of plastic and silicone extrusion, along with plastic and silicone injection molding processes to achieve production goals while fostering cross-functional collaboration.

Key Job Responsibilities:

• Team Leadership: Lead, mentor, and develop a high-performing operations team, fostering a culture of accountability, collaboration, and continuous improvement. Set clear goals and provide ongoing feedback to ensure team alignment with organizational objectives.
• Operations Management: Oversee daily production activities, ensuring efficient, safe, and high-quality operations. Monitor key performance indicators (KPIs) to meet production targets and delivery schedules.
• Process Improvement: Identify and implement process improvements to enhance efficiency, reduce waste, and improve product quality. Utilize analytical thinking to assess operational workflows and drive lean manufacturing initiatives.
• Demonstrated experience using MES and SCADA tools in managing production environments.
• Demonstrated leadership capabilities across multiple production facilities.
• Product Production Management (Clean Room Environment): Manage production processes in a clean room setting, ensuring adherence to strict environmental controls and quality standards for medical device manufacturing.
• Knowledge of Clean Room Manufacturing: Apply expertise in clean room production to ensure processes meet industry standards, including design, development, and manufacturing requirements.
• Communication Skills & Cross-Functional Collaboration: Communicate effectively with internal teams (e.g., supply chain, quality assurance, engineering, R&D) and external stakeholders to align operations with business goals. Facilitate cross-functional collaboration to resolve issues and drive project success.
• Compliance in a Clean Room Framework: Ensure all operations comply with relevant production standards including cGMP, ISO 9001,14001 and 45001 and maintain documentation for audits and inspections. Implement and monitor quality management systems to uphold compliance standards.
• Facility Maintenance: Oversee the maintenance and functionality of the manufacturing facility, ensuring a safe, clean, and compliant work environment. Coordinate with facility management teams to address repairs and upgrades.
• Equipment Maintenance: Manage the maintenance, calibration, and repair of production equipment to ensure operational reliability and minimize downtime. Oversee preventive maintenance schedules to optimize equipment performance.
• Deep Understanding of Plastic and Silicone Extrusion, and Molding Processes: Leverage technical expertise to optimize production techniques, troubleshoot issues, and ensure product quality.
• Statistical Process Control: Provide leadership in SPC implementation and improvements throughout all production processes.
• Analytical Thinking: Utilize data-driven decision-making to analyze operational performance, identify bottlenecks, and implement solutions. Conduct root cause analyses to address production challenges and improve outcomes.

Key Competencies:

• Strategic and tactical leadership
• Analytical problem-solving
• Regulatory compliance and quality focus
• Collaborative teamwork
• Process optimization and innovation

Requirements

Education, Skills and Experience Requirements:

• Bachelor’s degree in engineering, manufacturing, or a related field; advanced degree (e.g., MBA, MSEM) preferred.
• Minimum of 10-15 years of experience in operations management, with at least 15 years in medical device manufacturing.
• Proven expertise in plastic and silicone extrusion, and injection molding processes.
• Strong understanding of clean room operations and regulatory frameworks.
• Demonstrated leadership experience in managing diverse teams and driving operational success.
• Exceptional communication and interpersonal skills, with a track record of successful cross-functional collaboration.
• Analytical mindset with experience in process improvement methodologies (e.g., Lean, Six Sigma).
• Knowledge of facility and equipment maintenance practices in a manufacturing environment.
• Ability to thrive in a fast-paced, dynamic environment and manage multiple priorities.
• Proficiency in English required; additional languages are a plus.