Lean Production Manager (13485 Medical Device-Plastic Injection)

• Take ownership of the daily production schedule for our plastic injection molding operations
• Guide, train, and manage a team of operators and technicians
• Supervise the setup, daily operation, and maintenance of injection molding machines and automation equipment
• Ensure every step of the process aligns with ISO 13485, FDA guidelines, and other medical device standards.
• Track key production KPIs to identify bottlenecks and areas for growth.

• Bachelor’s degree / Diploma in Mechanical Engineering, Industrial Engineering, Plastics Technology, or a related field
• Min 6 years of hands-on experience in plastic injection molding and experience within medical device manufacturing is highly preferred
• Deep understanding of medical-grade, bio-compatible plastics and mold design
• Proven, practical experience navigating quality systems such as ISO 13485, GMP, and FDA regulations. Hands-on experience with medical device validation processes (IQ, OQ, PQ) is a major advantage
• Proficiency in ERP systems and production planning software
• A solid grasp of Lean Manufacturing or Six Sigma methodologies is required (Green/Black Belt or Lean Practitioner certifications are a big plus)
• Familiarity with CAD software and mold-flow analysis tools is also highly beneficial

• Experience within medical device manufacturing
• Hands-on experience with medical device validation processes (IQ, OQ, PQ)
• Green/Black Belt or Lean Practitioner certifications
• Familiarity with CAD software and mold-flow analysis tools

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