Manufacturing Engineer

We are seeking an experienced Advanced Manufacturing Engineer to support the implementation of design changes for medical device electronic hardware
.

This role will partner closely with a Lead Manufacturing Engineer and provide technical support across process validation, test method validation, manufacturing systems, and production support
.

• Process Validation
• PLM & ERP/MRP Systems in Manufacturing Engineering

• Support the development and validation of new manufacturing processes
  .
• Develop and execute process validation plans, including IQ/OQ/PQ
  .
• Perform statistical analysis to evaluate process repeatability and capability
  .
• Lead/support Test Method Validation and Gauge R&R activities.
• Support software validation for hardware test systems.
• Manage product BOM configurations within PLM systems
  .
• Integrate new components and BOM information into ERP/MRP systems
  .
• Create and maintain manufacturing documentation, including:
• Engineering protocols and reports
• Process risk documentation /
  PFMEA
• Manufacturing instructions
• Statistical analysis
• Generate documentation and BOM structures to support service depots.
• Provide engineering support to manufacturing operations.
• Investigate and resolve quality issues arising on the production floor.
• Collaborate with cross-functional teams during design changes and manufacturing implementation.

• Bachelor’s degree in engineering or another technical discipline
  .
• Minimum 4 years of relevant experience; 5+ years preferred.
• Experience with process validation and manufacturing engineering
  .
• Experience with Test Method Validation / Gauge R&R.
• Experience using PLM and ERP/MRP systems in a manufacturing environment.

• Master’s degree in a technical discipline.
• Medical device manufacturing experience
  .
• Experience in an electronics manufacturing environment
  .
• Knowledge of PFMEA, statistical analysis, and equipment/process qualification.