Process Engineer (Irvine)

About Us :

Precision Tube & Catheter, Inc. (PT&C) is a high-tech enterprise dedicated to the manufacturing of advanced materials and componentsspecializing in precision tubes and catheters for interventional and implantable medical devices. We produce high-quality medical tubes that meet stringent industry requirements for a diverse range of medical and pharmaceutical applications. Our commitment to innovation ensures that we exceed industry standards and support healthcare professionals in delivering effective patient care.

Position Summary :

We are seeking an experienced Manufacturing Process and Production Management professional. You will be a critical link between engineering, production operations, and quality assurance. You will not only understand the intricacies of precision tube and catheter manufacturing processes but also optimize them and lead teams to achieve key goals in safety, quality, delivery, and cost (SQDC). This role is vital to enhancing our competitiveness as a top-tier supplier in the medical device industry.

Key Responsibilities :

Process Management & Optimization :

• Own process development, validation, and qualification (including Operational Qualification / Performance Qualification) for new catheter products and precision tube components from NPI through to full-scale production.
• Analyze, optimize, and standardize existing manufacturing processes to solve technical issues, continuously improving efficiency, yield, and capacity.
• Lead Process Failure Mode and Effects Analysis (PFMEA) and the implementation of Control Plans.
• Drive continuous improvement (Kaizen) and Lean Manufacturing initiatives, introducing automation and process enhancements.

Production Operations Management :

Cross-Functional Leadership & Collaboration :

Qualifications & Requirements :

Essential :

Preferred :

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?

To Apply :

Please submit your resume and cover letter to Binbin.Su@ptncmed.com. We look forward to reviewing your application!

Precision Tube & Catheter, Inc. ( https : / / www.ptncmed.com / ) is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.