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Medical Device Molding Process Specialist
1 week ago
About the Role:
We are seeking a highly skilled Plastics Engineer to join our team as an Injection Molding Development Manager. As part of our medical device manufacturing division, you will be responsible for developing, optimizing, and maintaining injection molding processes used in the production of medical devices.
Key Responsibilities:
- Develop and optimize injection molding processes to ensure consistent part quality and efficiency.
- Collaborate with cross-functional teams on mold design, tool selection, and material qualification.
- Conduct troubleshooting and root cause analysis to resolve molding-related issues.
- Implement process improvements to enhance productivity, reduce waste, and minimize downtime.
- Support new product introductions by developing molding processes and providing technical input during design reviews.
- Maintain compliance with ISO 13485, FDA regulations, and other relevant standards for medical device manufacturing.
- Prepare technical reports, work instructions, and process documentation.
Qualifications:
- Bachelor's degree in Engineering (Mechanical, Manufacturing, Plastics, or related field).
- Years of experience in injection molding, preferably in a medical device manufacturing environment.
- Strong knowledge of mold design, materials science, and molding equipment.
- Experience with validation protocols (IQ/OQ/PQ) and regulatory compliance for medical devices.
- Proficiency in CAD software and statistical process control (SPC) techniques.
