Production Manager – Plastics Injection Molding & Tooling

About the role

We are seeking an experienced Production Manager to lead our plastic injection molding and tooling operations for medical devices. The role involves overseeing daily production, ensuring compliance with stringent quality standards, and driving continuous improvement in a fast‑paced manufacturing environment.

Key responsibilities

• Own the daily production schedule for plastic injection molding operations.
• Guide, train, and manage a team of operators and technicians.
• Supervise setup, operation, and maintenance of injection molding machines and automation equipment.
• Ensure all processes comply with ISO 13485, FDA guidelines, and other medical device standards.
• Track key production KPIs to identify bottlenecks and opportunities for growth.

Required profile

• Bachelor’s degree in Mechanical Engineering or equivalent.
• Minimum 10 years of experience in lean medical device manufacturing.
• Deep understanding of medical‑grade, biocompatible plastics and mold design (a plus).
• Proven experience with 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.

Required skills

• Lean Manufacturing and Six Sigma methodologies (Green/Black Belt or Lean Practitioner certifications preferred).
• Proficiency with ERP and production planning software.
• Familiarity with CAD software and mold‑flow analysis tools.
• Knowledge of ISO 13485, GMP, FDA regulations and validation protocols.