Job Description
Job Description
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.PI595df45f28de-25405-38939288