Plastic Process Engineer

Job Description :

The Plastic Engineer responsible for manufacturing the advanced materials and components for interventional and implantable medical devices. Our commitment to quality and innovation drives us to produce high-quality medical tubes that meet stringent industry standards supporting healthcare professionals in delivering exceptional patient care.

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.

Qualification :

Bilingual proficiency in Mandarin and English is highly preferred

Key Skills

Lean Manufacturing,Six Sigma,Distributed Control Systems,Continuous Improvement,Process Improvement,Minitab,Root cause Analysis,Process Engineering,cGMP,Kaizen,Programmable Logic Controllers,Manufacturing

Employment Type : Full Time

Experience : years

Vacancy : 1