A Process Engineer

3 days ago

Ulu Tiram, Johor, Malaysia SUPER HERO FAMILY ENTERPRISE Full time 60,000 - 72,000 per year

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.

  1. 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.

  1. 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).

  1. 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.

  1. 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.

  1. 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.

  1. 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.

  1. 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, RM6,000.00 per month

Benefits:

  • Professional development

Work Location: In person

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