Job Description

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...

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