Production Manager

Production Manager Key Responsibilities Production Oversight: Plan, coordinate, and control manufacturing processes for medical-grade injection molding and automated assembly lines. Monitor andoptimizethe performance ofinjection molding,automation equipment, robotics, and supporting systems to ensure consistent product quality and regulatory compliance.

Ensure production schedules are met with minimal downtime and maximum efficiency. Regulatory & Quality Compliance: Ensure all operations comply with ISO, FDA, GMP, and other relevant regulations. Collaborate with Quality Assurance to maintain documentation, traceability, and validation of processes. Lead root cause analysis and corrective actions for quality or compliance issues.

Process & Automation Improvement: Identifyand implement process improvements to increase efficiency, reduce waste, and maximize ROI (Lean, 5S, Six Sigma, etc.) Analyze production and quality data to drive continuous improvement initiatives. Team & Technology Leadership: Supervise, train, and develop production supervisors, process technicians, and operators.

Foster a culture of safety, accountability, and continuous learning, especially regarding processes/procedures, and regulatory requirements. Resource & Asset Management: Manage labor, materials, and equipment to optimize production output and cost. Coordinate with maintenance and engineering to ensure equipment reliability, preventive maintenance, and rapid troubleshooting.

Health, Safety & Compliance: Enforce compliance with health, safety, and environmental regulations, especiallyregardingautomated machinery and cleanroom environments. Lead safety meetings, risk assessments, and incident investigations. Reporting & Communication: Prepare and present production and compliance performance reports, metrics, and improvement plans for senior management.

Maintain accurate records of production, downtime, maintenance, and employee performance.

Qualifications

Bachelor’s degree in engineering discipline, or a strong work history in lieu of a degree. Experience with ISO 13485, FDA, GMP, and other medical device regulatory standards. Experience with Lean Manufacturing, Six Sigma, or similar methodologies. Excellent leadership, communication, and problem-solving skills. Proficiency with ERP/MRP systems, manufacturing analytics, and Microsoft Office Suite.

Key Competencies Leadership & Team Development Medical Device Regulatory Compliance Automation & Robotics Management Cleanroom & Environmental Control Production Planning & Scheduling Quality & Process Improvement Safety & Analytical Skills