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Sr Manufacturing Engineer

Katalyst Healthcares and Life Sciences

Summary:
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.

Required Qualifications:
  • 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
Vacancy posted 3 days ago
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