Plastic Process Engineer (Irvine)

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.

Position Summary :

We are Precision Tube & Catheter, Inc. (PT&C), a leader in advanced medical tube manufacturing for interventional and implantable devices. We seek a hands-on Plastic Process Engineer to drive R&D innovation and optimize catheter production processes. This role will design tooling (SolidWorks), 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.

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 toolingincluding extrusion dies, injection molds, balloon molds, and fixturesusing 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 :

Working Conditions :

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 with the Americans with Disabilities Act (ADA).

Benefits / Other :

We believe our employees are our greatest resource. We offer a competitive salary and benefits package including 401(k) with employer contribution, paid holidays, and vacation. Insurance coverage includes medical, dental, vision, and prescription drugs.

We are proud to be an equal-opportunity workplace. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status. If you have a disability or special need that requires accommodation, please let us know. If applying for positions in the U.S., you must be eligible to work in the U.S. without needing an employer-sponsored visa (work permit).

Why Join PT&C?

At PT&C, you will be part of a dedicated team that values innovation, integrity, and collaboration. As an Extrusion Process / R&D Engineer, you will contribute to the development of cutting-edge medical products that enhance patient care globally.

To Apply :

Please submit your resume and cover letter to Binbin.Su@ptncmed.com. We look forward to welcoming you to our team!

Precision Tube & Catheter, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.