Production Manager - Plastic Injection Molding & Tooling

About the role

A production manager is needed to run plastic injection molding operations, covering the daily production schedule, the people and the machines. The work follows medical device standards such as ISO 13485 and FDA guidelines.

Key responsibilities

• Take ownership of the daily production schedule for the 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 complies with ISO 13485, FDA guidelines and other medical device standards
• Track key production KPIs to identify bottlenecks and areas for growth

Required profile

• Bachelor's degree in Mechanical Engineering or equivalent
• Minimum 10 years of experience in a lean medical devices manufacturing environment
• Proven, practical experience navigating quality systems such as ISO 13485, GMP and FDA regulations; hands-on experience with medical device validation (IQ, OQ, PQ) is a major advantage
• Solid grasp of Lean Manufacturing or Six Sigma methodologies (Green/Black Belt or Lean Practitioner certification is a big plus)
• Deep understanding of medical-grade, bio-compatible plastics and mold design is a plus

Required skills

• Proficiency in ERP systems and production planning software
• Familiarity with CAD software and mold-flow analysis tools is highly beneficial

Candidates apply through the recruiter; only shortlisted candidates will be contacted.