Sr Manufacturing Engineer

The role focuses on process validation, test method validation, PLM/ERP management, manufacturing documentation, and production support. Seeking a Sr Manufacturing Engineer to support implementation of design changes for medical device electronic hardware.

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