Plastic Process Engineer
Plastic Process Engineer
Posted on :
24-07-2025
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1 Vacancy
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Job Description
Job Summary:
Key Responsibilities:
- Monitor and analyze industry trends and market demands to identify new application opportunities; develop R&D plans aligned with company capabilities.
- Lead or support the development and optimization of catheter materials and process designs; assess material compatibility with catheter manufacturing processes.
- Design catheter components and associated tooling-including extrusion dies injection molds balloon molds and fixtures-using SolidWorks.
- Manage the non-conformance process by driving NC CAPA and SCAR activities including root cause analysis verification validation and implementation of corrective actions.
- Develop and revise technical documentation such as SOPs BOMs Travelers EFTs (Work Orders) MPIs NCOs DHRs DHFs FMEAs Control Plans and other quality or manufacturing documents.
- Plan and execute validation activities (IQ/OQ/PQ) for processing equipment and medical device components in compliance with FDA regulations.
- Perform process verification (OQ/PQ) for the production of extruded components and subassemblies.
- Analyze data using Minitab or JMP to identify trends troubleshoot issues and implement cost improvement projects (CIP) for enhanced efficiency and savings.
- Manage multiple concurrent projects and lead cross-functional multi-site teams in the development and optimization of catheter processing and manufacturing.
- Provide technical support for post-launch production processes and drive continuous improvement initiatives for new product introductions.
- Define and maintain technical specifications for products raw materials and testing methodologies.
- Stay informed on the latest advancements in polymers medical device manufacturing and process engineering; contribute to building the companys R&D knowledge base.
- Collaborate closely with R&D Quality Production and Supply Chain teams to ensure material and process strategies support product development goals.
- Ensure compliance with GMP and ISO 13485 standards throughout all activities.
Qualifications:
- Masters degree or higher in Polymer Engineering Materials Science Chemical Engineering or a closely related field.
- A minimum of 2 years of relevant experience preferred; background in medical device materials or catheter manufacturing is highly desirable.
- Strong proficiency in polymer processing including compounding blending modification and testing; working knowledge of plastics processing equipment is required with hands-on experience preferred.
- Familiarity with the characterization of polymers and blends used in balloon and tubing applications including techniques such as DSC SEM TEM Raman Spectroscopy FTIR XRF XRD X-Ray Tomography GPC WAXS and rheometry.
- A minor or academic background in Mechanical Engineering is preferred.
- Bilingual proficiency in Mandarin and English is highly preferred.
Employment Type
Full-time
Key Skills
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