What are the responsibilities and job description for the Manufacturing Engineer position at JVM Global Inc?
Title: Manufacturing Engineer, Injection Molding Expert (Medical Device)
Job Summary:
Our client is seeking a highly skilled Senior Manufacturing Engineer with deep expertise in injection molding to support our medical device manufacturing operations. The ideal candidate will have at least 2 years of hands-on experience in injection molding within a regulated medical device environment and a strong understanding of process development, tooling, and automation.
Key Responsibilities:
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Lead the development, optimization, and validation of injection molding processes for new and existing medical device components.
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Collaborate with cross-functional teams to define and implement molding requirements from concept through production.
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Strong Verbal and Technical Writing skills to develop and execute documentation including IQ/OQ/PQ protocols, method sheets, production forms, and traceability records in compliance with ISO 13485 and 21 CFR Part 820.
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Perform root cause analysis, support CAPA investigations, and conduct risk assessments related to molding processes.
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Experience with injection molding tooling such as mold design, modifications, and maintenance.
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Select and process various plastic materials considering their mechanical and thermal properties.
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Work with automated injection molding machines such as those that pick up parts directly.
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Support ongoing continuous improvement efforts in quality, throughput, and cost reduction.
Requirements:
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Minimum of 5 years of injection molding experience in the medical device industry.
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Strong technical writing and documentation skills, with experience in regulated environments.
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In-depth knowledge of ISO 13485, 21 CFR Part 820, and GMP.
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Experience with material selection, tooling, and molding automation.
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Self-motivated, hands-on, and comfortable working on the production floor.