Sr Manufacturing Engineer

Job Title: Sr Manufacturing Engineer
Job ID: 25282
Duration: 24 Months
Location: Lafayette Colorado 80026
Pay Rate: $55.00 - $60.00/hr.

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 .

• Equipment Qualification (IQ/OQ/PQ)
• Process Validation
• Statistical Analysis
• Process Repeatability Studies

• Gauge R&R
• Test Method Validation (TMV)
• Software Validation
• Measurement System Analysis

• Product Lifecycle Management (PLM)
• ERP/MRP Systems
• BOM Creation & Configuration
• Engineering Change Management

• 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