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