What are the responsibilities and job description for the Senior Manufacturing Engineer position at Infotree Global Solutions?
Sr Manufacturing Engineer (Medical Devices) || Lafayette, Colorado 80026
24 months
Top 3 technical skills that are required for the role:
1. Process Validation
2. Test Method Validation (Gauge R&R)
3. Use of PLM and ERP systems as manufacturing engineer
Education Required: Bachelor’s degree in a technical field
What product line will this person support? Electrosurgical Hardware
This position is for an Advanced Manufacturing Engineer. This role will support a lead manufacturing engineer during implementation of a new medical device (electronic hardware).
Responsibilities include, but are not limited to:
- Support development and validation for new production processes.
- Manage product BOM configurations in PLM system.
- Integrate new components with manufacturing ERP/MRP systems.
- Develop and execute plans, including statistical analysis, to evaluate process repeatability through equipment qualification and process validation (IQ/OQ/PQ).
- Perform Test Method Validation and Software Validation for hardware test systems.
· Define and generate all required documentation in support of manufacturing protocols, reports, changes, and manufacturing instructions. These include Engineering protocols, reports, process risk documents (PFMEA), manufacturing instructions, change orders and statistical analysis.
- Generate documents and BOM structures to support service depots.
· Provide engineering support to manufacturing operations and address quality issues arising on the production floor.
Minimum Requirements
· Bachelor’s Degree in a technical discipline
· Minimum 4 years of experience required.