Process Engineer

2 days ago

Ulu Tiram, Johor, Malaysia Agensi Pekerjaan Alpha Alliance Sdn Bhd Full time 48,000 - 72,000 per year

Job Responsibilities

1. Process Development & Optimization

  • Develop, validate, and optimize plastic injection molding processes for medical device components.
  • Define process parameters (temperature, pressure, cooling time) for new and existing tools.
  • Apply Scientific Molding principles and DOE to ensure process stability and repeatability.

2. Validation & Regulatory Compliance

  • Lead IQ/OQ/PQ validation activities in compliance with ISO 13485, FDA regulations, and customer requirements.
  • Prepare and maintain validation protocols, reports, and change control documentation.

3. Tooling & Equipment Support

  • Work with toolmakers and design engineers on new mold development and modifications.
  • Support mold trials, sampling, and evaluation of tool performance.
  • Recommend and validate new molding machines and auxiliary equipment.

4. Defect Analysis & Troubleshooting

  • Identify and resolve molding defects such as flash, short shots, sink marks, voids, and contamination.
  • Use root cause analysis tools (5 Whys, Fishbone Diagram, FMEA) to implement corrective actions.

5. Documentation & Process Control

  • Create and update process documentation including setup sheets, molding parameters, and control plans.
  • Implement and monitor SPC to maintain process control and minimize variation.

6. Cross-functional Collaboration

  • Collaborate with R&D, QA, Production, and Regulatory Affairs during new product introduction.
  • Train operators and technicians on molding procedures, process changes, and cleanroom practices.

7. Continuous Improvement & Cost Reduction

  • Lead or participate in Lean, Kaizen, or Six Sigma projects to improve yield, reduce cycle time, and minimize scrap.
  • Analyze process capability and recommend process improvements.

8. Cleanroom & Safety Compliance

  • Ensure molding processes comply with cleanroom standards (ISO Class 7/8) and hygiene protocols.
  • Participate in risk assessments and ensure safe handling of medical-grade materials and equipment.

Tools & Technologies

  • Scientific Molding, Decoupled Molding, Cavity Pressure Monitoring
  • Software: Moldflow, SolidWorks, MiniTab, IQMS/ERP systems
  • Materials: Medical-grade thermoplastics (PC, ABS, PEEK, PEBA)
  • Standards: ISO 13485, GMP
  • Master Molder certification is an advantage

Job Requirements

  • Degree in Mechanical Engineering, Polymer Engineering, or related field.
  • 3–5 years' experience in plastic injection molding, preferably in the medical device industry.
  • Strong knowledge of Scientific Molding, DOE, and Moldflow analysis.
  • Hands-on experience with IQ/OQ/PQ validation and ISO 13485/FDA compliance.
  • Skilled in process documentation (setup sheets, work instructions, control plans).
  • Familiar with root cause analysis tools (SPC, FMEA, 5 Whys, Fishbone Diagram).
  • Exposure to Lean, Kaizen, or Six Sigma projects is an advantage.

Job Type: Full-time

Pay: RM4, RM6,000.00 per month

Benefits:

  • Opportunities for promotion
  • Professional development

Application Question(s):

  • Have you worked in a clean-room-controlled production environment before?

Work Location: In person

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