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Precision Tube & Catheter, Inc. · 4 hours ago

Process Engineer

Irvine, CA

Full-time

Onsite

Senior Level

5+ years exp

Precision Tube & Catheter, Inc. is a high-tech enterprise dedicated to the manufacturing of advanced materials and components for medical devices. They are seeking an experienced Manufacturing Process and Production Management professional to optimize manufacturing processes and lead teams to achieve key goals in safety, quality, delivery, and cost.

Medical Device

No H1B

Hiring Manager

Icey Liu

Responsibilities

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

Manage and supervise the daily activities of production teams to ensure the production schedule is met on-time, in-full, and to specification

Be accountable for production line performance metrics (KPIs) such as OEE, Output, and Scrap Rate through effective resource allocation and personnel scheduling

Ensure the production floor strictly adheres to cGMP, ISO 13485, and relevant medical device regulations (e.g., 21 CFR Part 820) quality system requirements, maintaining an audit-ready state at all times

Manage production-related Non-Conformance Reports (NCRs), deviation investigations, and Corrective and Preventive Actions (CAPA)

Work closely with R&D to ensure the Design for Manufacturability (DFM) of new products

Collaborate with Quality Assurance (QA) and Quality Control (QC) departments to ensure products meet all specifications and standards

Partner with Supply Chain and Procurement to optimize the use of raw materials and consumables

Demonstrate excellent vertical management and horizontal collaboration skills, enabling effective communication and collaboration with Chinese R&D, production teams, and the local US team

Qualification

Process DevelopmentLean ManufacturingMedical Device RegulationsCatheter ManufacturingProject ManagementSolidWorksFluency in EnglishMandarinProblem-SolvingTeam Management

Required

Bachelor's degree or higher in an Engineering discipline (Mechanical, Polymer Science, Biomedical, Industrial Engineering, etc.)

5+ years of hands-on experience in the medical device industry, specifically in catheters or similar interventional disposables in a process, manufacturing engineering, or production management role

Strong technical foundation in catheter manufacturing processes; expertise in extrusion, braiding, tubing processing, assembly, and packaging is required

Demonstrated practical experience with Lean Manufacturing and Continuous Improvement principles (e.g., 5S, VSM, TPM; Six Sigma Green/Black Belt is a plus)

In-depth knowledge of medical device quality management systems (ISO 13485, 21 CFR Part 820) and their application in production

Excellent problem-solving, analytical, and project management skills

Strong leadership, communication, and team management abilities

Fluency in English (written and spoken). Proficiency in Mandarin Chinese is required to ensure smooth collaboration with China-based teams