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Precision Tube & Catheter, Inc. · 16 hours ago

Plastic Process Engineer

Irvine, CA

Full-time

Onsite

Entry, Mid Level

2+ years exp

Precision Tube & Catheter, Inc. (PT&C) is a leader in advanced medical tube manufacturing for interventional and implantable devices. They seek a hands-on Plastic Process Engineer to drive R&D innovation and optimize catheter production processes, ensuring compliance with industry standards while collaborating across teams.

Medical Device

No H1B

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 company’s 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

Polymer EngineeringSolidWorksFDA validationsData analyticsPolymer processingMedical device materialsBilingual MandarinContinuous improvementCross-functional collaborationTechnical documentation

Required

Master's 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