Senior Manufacturing Engineer

Sr. Manufacturing Engineer (24-month contract // Lafayette, CO):

Top 3 Skills Required:

1. Process Validation
2. Test Method Validation (Gauge R&R)
3. Use of PLM and ERP systems

Education Required: Bachelor’s degree in a technical field

Years’ Experience Required: 5 years minimum experience with manufacturing engineering activities

Description:

This position is for an Advanced Manufacturing Engineer. This role will support a lead manufacturing engineer during implementation of design changes to a medical device (electronic hardware).

Duties:

• 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 manufacturing experience

Nice to Have:

• Master’s Degree in a technical discipline
• Medical Device and/or Manufacturing Experience
• Experience in an electronics manufacturing environment