KH
Sr Manufacturing Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
Hybrid
Senior
3 months ago
- ERP
- PFMEA
3 months ago
Not enough detail in this posting to match
Seeking a Sr Manufacturing Engineer to support implementation of design changes for medical device electronic hardware. The role focuses on process validation, test method validation, PLM/ERP management, manufacturing documentation, and production support. Roles & Responsibilities:
- Support development and validation of new manufacturing processes.
- Execute IQ/OQ/PQ Process Validations.
- Perform Test Method Validation (Gauge R&R) and Software Validation.
- Manage BOMs and product configurations in PLM systems.
- Integrate components into ERP/MRP systems.
- Create and maintain:
- Manufacturing Protocols & Reports
- PFMEA
- Manufacturing Instructions
- Engineering Change Orders (ECOs)
- Statistical Analysis Documentation
- Support service depot documentation and BOM structures.
- Troubleshoot production and quality issues on the manufacturing floor.
- Bachelor's degree in Engineering or Technical Discipline.
- Minimum 4–5 years Manufacturing Engineering experience.
- Experience with:
- Process Validation (IQ/OQ/PQ)
- Test Method Validation (Gauge R&R)
- PLM Systems
- ERP/MRP Systems
- Statistical Analysis
- Manufacturing Documentation
Sr Manufacturing Engineer · Katalyst Healthcares & Life Sciences