Production Manager

Stevanato Group S.p.A.•Fishers, IN

13d•Onsite

About The Position

The Production Manager will be responsible for overseeing and optimizing manufacturing processes for medical-grade injection molding and automated assembly lines. This role requires a strong understanding of regulatory compliance, process improvement methodologies, and team leadership. The Production Manager will ensure production schedules are met efficiently while maintaining high standards of quality and safety, particularly within cleanroom environments. This position involves managing resources, leading continuous improvement initiatives, and reporting performance to senior management.

Requirements

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.

Nice To Haves

Automation & Robotics Management
Cleanroom & Environmental Control
Production Planning & Scheduling
Quality & Process Improvement
Safety & Analytical Skills

Responsibilities

Plan, coordinate, and control manufacturing processes for medical-grade injection molding and automated assembly lines.
Monitor and optimize the performance of injection 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.
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.
Identify and 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.
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.
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.
Enforce compliance with health, safety, and environmental regulations, especially regarding automated machinery and cleanroom environments.
Lead safety meetings, risk assessments, and incident investigations.
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.