Job 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 / 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 adv...
Requirements 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 adv...