PROCESS ENGINEER (PLASTIC INJECTION MOLDING)

Responsibilities

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

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 correcti...