Plastic Process Engineer

About Us

Precision Tube & Catheter, Inc. (PT&C) is a high-tech enterprise dedicated to manufacturing advanced materials and components for interventional and implantable medical devices. We produce high-quality medical tubes used in various applications, including anesthesiology, respiratory equipment, and biopharmaceutical laboratory equipment. Our commitment to innovation and excellence drives us to exceed industry standards and client expectations.

We seek a hands-on Plastic Process Engineer to drive R&D innovation and optimize catheter production processes. This role will design tooling (Solid Works), lead quality initiatives (NC/CAPA/SCAR), execute FDA validations (IQ/OQ/PQ), and leverage data analytics (Minitab/JMP) to enhance efficiency. The engineer will ensure compliance with GMP/ISO 13485 while collaborating cross-functionally to develop next-generation medical products.

• 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 Solid Works.
• 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.

• 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.
• A minor or academic background in Mechanical Engineering is preferred.
• Bilingual proficiency in Mandarin and English is highly preferred.

Work is conducted in both office and manufacturing environments, requiring compliance with all applicable safety protocols and personal protective equipment (PPE) guidelines. The role may involve prolonged periods of standing and occasional lifting of materials up to 25 pounds, in accordance with applicable workplace safety regulations. Reasonable accommodations may be provided in accordance…