Position: Manufacturing Process Engineer/ Senior Manufacturing Engineer

Location: Irvine, CA

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 production1.
  • Analyze, optimize, and standardize existing manufacturing processes to solve technical issues, continuously improving efficiency, yield, and capacity2.
  • 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:
  • 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 times12.
  • Manage production-related Non-Conformance Reports (NCRs), deviation investigations, and Corrective and Preventive Actions (CAPA).

• Cross-Functional Leadership & Collaboration:
  • Work closely with R&D to ensure the Design for Manufacturability (DFM) of new products6.
  • 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 skills9, enabling effective communication and collaboration with Chinese R&D, production teams, and the local US team.

Qualifications & Requirements:

• 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.

Preferred:

• Experience with technology transfer or New Product Introduction (NPI) is a plus1.
• Strong background in precision tube fabrication and catheter manufacturing process technology is a plus2.
• Experience working in cross-regional and cross-cultural teams is advantageous.