Plastic Process Engineer

Irvine, CA - USA

Monthly Salary: Not Disclosed

Posted on: 7 hours ago

Vacancies: 1 Vacancy

Job Summary

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:

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

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 hea...

Job Description:

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:

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