Sr Manufacturing Engineer

Job in Lafayette, Boulder County, Colorado, 80026, USA

Listing for: Katalyst Healthcares & Life Sciences

Full Time position
Listed on 2026-06-10

Job specializations:

Engineering
Manufacturing Engineer, Quality Engineering
Manufacturing / Production
Manufacturing Engineer, Quality Engineering

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. Roles & 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

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