Mechanical Engineer GCR Professional Services
San Diego, California30+ days ago
Katalyst Healthcares & Life Sciences
- San Diego, CA
- 30+ days ago
Highlights
Roles & Responsibilities: Develop and qualify injection molding processes and production cells. Partner directly with molding suppliers on quality and process capability.
Numbers & Facts
| Location | San Diego, CA |
Description
Roles & Responsibilities:
Requirements:
- Develop and qualify injection molding processes and production cells.
- Lead mold design reviews and supplier tooling development.
- Qualify new molds and molding processes for production.
- Troubleshoot molding defects and drive RCA/CAPA activities.
- Partner directly with molding suppliers on quality and process capability.
- Support supplier qualification, NPI and sustaining programs.
- Drive continuous improvement and ensure regulatory compliance.
Requirements:
- 9+ Years Medical Device Experience.
- Plastic Injection Molding – Large / Complex Parts.
- Injection Molding Process & Production Cell Qualification.
- Mold Design Reviews & Tooling Development.
- New Mold & Process Qualification.
- IQ / OQ / PQ & Process Validation.
- Injection Molding Defect Troubleshooting.
- Root Cause Analysis & Corrective Actions.
- CAPA / SCAR.
- Process Capability & Supplier Quality.
- Supplier Qualification / NPI / Sustaining Quality.
- FDA & ISO 13485 Environment.
- Bachelor's Degree in Engineering or Related Field.