Production Manager

 What We Offer

• A dynamic team environment in a growth-focused medical-device, small component manufacturing facility.
• Bonus/production incentive structure based on performance.
• Comprehensive benefits program (health, dental, retirement savings, etc.).
• Opportunity to lead mission-critical operations producing high-precision parts and to drive manufacturing excellence.
• Professional development opportunities and career growth in a manufacturing leadership role.

Position Summary

The Production Manager is responsible for the management, and oversight of all production operations within the molding facility (including clean-room production). This role will ensure that production meets cost, quality, delivery, and safety targets. The ideal candidate will have strong experience in plastic injection-molding of small components including medical parts and familiarity with clean-room protocols and GMP/ISO quality systems.

• Lead, manage and direct all production activities for injection-molding operations (including setup, run-time, shutdown, and preventative maintenance) to meet production schedules and customer demand.
• Ensure operations comply with all relevant regulations, quality standards (such as ISO 13485/ISO 9001), medical device production standards, and clean-room protocols (e.g., ISO 7/8, GMP) as applicable.
• Monitor key production metrics (e.g., throughput, yield, scrap rate, OTD, downtime) and drive continuous improvement to increase efficiency, reduce waste, and minimize cost.
• Develop and implement production plans, resource allocation (machinery, tooling, labor), scheduling, and staffing to optimize output while maintaining flexibility for change-overs and new product introductions.
• Work closely with maintenance, tooling, engineering and quality teams to troubleshoot process issues (molding defects, machine performance, change-over delays), implement corrective action (root-cause analysis, CAPA) and sustain improvements.
• Oversee and enforce strict clean-room operational discipline: gowning, contamination control, cleaning schedules, material flow, equipment calibration/verifications.
• Manage and develop production supervisors and teams across shifts: hiring, training, performance management, succession planning, and fostering a culture of safety, quality and accountability.
• Champion Lean/continuous improvement methodologies (Kaizen events, 5S, TPM, Six Sigma) to elevate process maturity and manufacturing excellence.
• Prepare and manage departmental budgets, forecasts, production cost controls, tooling and MRO inventory. Report production status, KPI performance and improvement initiatives to senior leadership.
• Ensure safety of workforce, compliance with OSHA or relevant workplace safety standards, and maintenance of a safe and ergonomic work environment.
• Lead new product introduction (NPI) and qualification efforts for tooling, molds and equipment (IQ/OQ/PQ) in collaboration with engineering and quality teams when applicable.
• Serve as the production representative in cross-functional teams (engineering, quality, supply chain) and support customer audits/visits related to the manufacturing process and clean-room operations.

• Bachelor’s degree in Manufacturing Engineering, Industrial Engineering, Plastics Technology, or related field (or equivalent experience).
• Minimum 5-10 years’ experience in manufacturing/production roles, ideally in plastic injection-molding of small components (medical device, auto, packaging or similar).
• Demonstrated leadership/supervisory experience, preferably managing multi-shift operations.
• Strong knowledge of plastic injection-molding processes, tooling, machine setup/operation, mold maintenance, trimming/finishing, material handling.
• Proven track record of driving continuous improvement, lean manufacturing, cost reduction and quality improvements.
• Excellent problem-solving skills: ability to perform root-cause analysis, implement corrective action and sustain results.
• Strong interpersonal, communication and team-leadership skills. Capable of training and developing staff.
• Proficiency with manufacturing systems, metrics, ERP/production reporting tools, Microsoft Office (Excel, Word, PowerPoint).
• Ability to work in a clean-room environment and promote strict operational discipline.

Preferred:

• Prior experience in a medical-device manufacturing environment, with clean-room certification or direct experience in ISO 7/8 or Class 100 000/10 000 clean-room operations.
• Knowledge of ISO 13485, GMP, FDA medical-device regulations.
• Experience with equipment qualification/validation (IQ/OQ/PQ) and APQP/PPAP processes.
• Lean Six Sigma certification (Green Belt or Black Belt).
• Familiarity with small-part injection-molding, micro-molding, multi-cavity tooling, hot-runner systems, automation/robotic removal.

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