Sr Manufacturing Engineer

Karwell Technologies

Lafayette, CO

JOB DETAILS
SKILLS
Bill of Materials (BOM), Documentation, ERP (Enterprise Resource Planning), Engineering, Engineering Change Order, Identify Issues, Manufacturing, Manufacturing Engineering, Manufacturing/Industrial Processes, Medical Equipment, Process Failure Mode and Effects Analysis (PFMEA), Process Validation, Product Lifecycle Management, Product Management, Production Support, Quality Assurance Methodology, Software Validation, Statistics, Support Documentation, Systems Administration/Management, Testing, Validation Testing, eCos
LOCATION
Lafayette, CO
POSTED
9 days ago
Job Description:
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

About the Company

K

Karwell Technologies