Bill of Materials (BOM), Documentation, ERP (Enterprise Resource Planning), Engineering, Engineering Change Management, Engineering Change Order, Identify Issues, Manufacturing, Manufacturing Engineering, Manufacturing/Industrial Processes, Medical Equipment, Process Failure Mode and Effects Analysis (PFMEA), Process Validation, Product Lifecycle Management, Product Management, Production Support, Quality Assurance Methodology, Software Validation, Statistics, Support Documentation, Systems Administration/Management, Systems Analysis, Testing, Validation Testing, eCos
Job Title: Sr Manufacturing Engineer
Job ID: 25282
Duration: 24 Months
Location: Lafayette Colorado 80026
Pay Rate: $55.00 - $60.00/hr.
Job 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.
Top 3 Must-Have Skills
1. Process Validation
- Equipment Qualification (IQ/OQ/PQ)
- Process Validation
- Statistical Analysis
- Process Repeatability Studies
2. Test Method Validation
- Gauge R&R
- Test Method Validation (TMV)
- Software Validation
- Measurement System Analysis
3. PLM & ERP Systems
- Product Lifecycle Management (PLM)
- ERP/MRP Systems
- BOM Creation & Configuration
- Engineering Change Management
Key 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