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Sr Manufacturing Engineer

Katalyst Healthcares & Life Sciences

  • Lafayette, CO
  • 30+ days ago
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    Skills

    • Bill of Materials (BOM)unmatched
    • Documentationunmatched
    • ERP (Enterprise Resource Planning)unmatched
    • Engineeringunmatched
    • Engineering Change Orderunmatched
    • Identify Issuesunmatched
    • Manufacturingunmatched
    • Manufacturing Engineeringunmatched
    • Manufacturing/Industrial Processesunmatched
    • Medical Equipmentunmatched
    • Process Failure Mode and Effects Analysis (PFMEA)unmatched
    • Process Validationunmatched
    • Product Lifecycle Managementunmatched
    • Product Managementunmatched
    • Production Supportunmatched
    • Quality Assurance Methodologyunmatched
    • Software Validationunmatched
    • Statisticsunmatched
    • Support Documentationunmatched
    • Systems Administration/Managementunmatched
    • Testingunmatched
    • Validation Testingunmatched
    • eCosunmatched

    Description

    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

    Numbers & Facts

    LocationLafayette, CO

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