Found Description
Key Responsibilities
- 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.
Requirements
- Bachelor's degree in Mechanical Engineering ir equivalent
- Min 10 years of experience in lean medical devices manufacturing environment
- Deep understanding of medical-grade, bio-compatible plastics and mold design will be a plus
- Proven, practical experience navigating quality systems such as ISO 13485, GMP, and FDA regulations. Hands-on experience with medical device validation processe...
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