Job Description

:

1. Process Development & Optimization

? Develop, validate, and optimize plastic injection molding processes for medical device components.

? Define process parameters (e.g., temperature, pressure, cooling time) for new and existing tools.

? Use scientific molding principles and DOE to ensure repeatability and process robustness.

2. Validation & Regulatory Compliance

? Lead IQ/OQ/PQ (Installation Qualification, Operational Qualification, Performance Qualification) activities.

? Ensure all molding processes comply with ISO 13485, FDA regulations, and customer-specific quality requirements.

? Prepare and maintain validation protocols, reports, and change control documentation.

3. Tooling & Equipment Support

? Collaborate with toolmakers and design engineers on new mold development and modifications.

? Support mold trials and sampling to evaluate tool performance.

? Recommend and validate new molding machines and auxiliary equipment (e.g., dryers, temperature controllers).

4. Defect Analysis & Troubleshooting

? Identify and resolve molding issues such as flash, short shots, sink marks, voids, and contamination.

? Use root cause analysis tools like 5 Whys, Fishbone Diagrams, and FMEA to drive corrective actions.

5. Documentation & Process Control

? Create and update process documentation: setup sheets, molding parameters, work instructions, control plans.

? Implement and monitor SPC (Statistical Process Control) to maintain process control and minimize variation.

6. Cross-functional Collaboration

? Work closely with R&D, Quality Assurance, Production, and Regulatory Affairs during new product introduction (NPI).

? Train operators and technicians on molding procedures, process changes, and cleanroom practices.

7. Continuous Improvement & Cost Reduction

? Lead or participate in Lean Manufacturing, Kaizen, or Six Sigma projects.

? Analyze process capability and drive initiatives to improve yield, reduce cycle time, and minimize scrap.

8. Cleanroom & Safety Compliance

? Ensure molding processes adhere to cleanroom standards (e.g., 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 (e.g., PC, ABS, PEEK, PEBA)

? Standards: ISO 13485, GMP

? Master Molder will be advantages

Job Requirements:

? Degree in Mechanical Engineering, Polymer Engineering, or related field

? Minimum 3-5 years experience in plastic injection molding, preferably in the medical device industry

? Strong knowledge of Scientific Molding principles, Design of Experiments (DOE), and Moldflow analysis

? Hands-on experience with IQ/OQ/PQ validation and compliance with ISO 13485 and FDA requirements

? Skilled in preparing and updating process documents: setup sheets, work instructions, control plans

? Familiar with root cause analysis tools: SPC, FMEA, 5 Whys, Fishbone diagrams

? Exposure to Lean Manufacturing, Kaizen, or Six Sigma projects is an advantage

? Good English communication skills (verbal & written

Job Type: Permanent

Pay: RM5,000.00 - RM6,000.00 per month

Benefits:

Professional development
Work Location: In person