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process engineer

Sem Matic Sdn BhdMalaysia

1 hari lalu

Penerangan pekerjaan

Job description

1. Process Development & Optimization

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

4. Defect Analysis & Troubleshooting

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

Analysis tools like 5 Whys, Fishbone Diagrams, and FMEA to drive corrective actions.

5. Documentation & Process Control

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.

Qualification Requirement :

Candidate must possess at least Bachelor's Degree in Chemical Engineering / Manufacturing

At least 3 Year(s) of working experience in the related field

Knowledge of ISO 13485 and other quality standard as well as safety regulatory requirements.