Advanced Manufacturing Engineer

Advanced Manufacturing Engineer (Sr. Manufacturing Engineer) Lafayette, CO | Onsite 1-Year Contract We’re actively seeking an experienced Advanced Manufacturing Engineer to support the implementation of design changes for electrosurgical hardware within the medical device industry. Top Technical Skills

• Process Validation – IQ/OQ/PQ
• Test Method Validation – Gauge R&R, statistical analysis
• PLM & ERP/MRP Systems – BOM configuration and manufacturing integration
• Manufacturing process development and equipment qualification
• PFMEA, change control, manufacturing documentation
• Experience with electronic hardware manufacturing

Key Responsibilities

• Support development and validation of new production processes
• Develop and execute process validation plans, including IQ/OQ/PQ
• Perform Test Method Validation and Gauge R&R for hardware test systems
• Manage product BOM configurations in PLM systems
• Integrate new components with ERP/MRP systems
• Develop engineering protocols, reports, manufacturing instructions, PFMEAs and change orders
• Provide engineering support to manufacturing operations and resolve production-floor quality issues
• Support service depot documentation and BOM structures
• Partner with cross-functional teams during design changes and product implementation

Requirements

• Bachelor’s degree in Engineering or another technical discipline
• 4–5+ years of relevant experience
• Medical device and/or manufacturing experience strongly preferred
• Experience in an electronics manufacturing environment preferred
• Master’s degree is a plus
• Must be onsite in Lafayette, Colorado

If you have strong experience with process validation, test method validation, Gauge R&R, PLM/ERP systems, and medical device manufacturing , I’d like to connect.

AJ1