Sr Manufacturing Engineer
Katalyst Healthcares & Life SciencesLafayette, CO
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Overview
Remote
On-site
Job Description
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.
- 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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FAQs About Sr Manufacturing Engineer Jobs at Katalyst Healthcares & Life Sciences
What is the work location for this position at Katalyst Healthcares & Life Sciences?
This job at Katalyst Healthcares & Life Sciences is located in Lafayette, CO, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Katalyst Healthcares & Life Sciences?
Employer has not shared pay details for this role.
What employment applies to this position at Katalyst Healthcares & Life Sciences?
The employer has not provided this information. This may be discussed during the hiring process.
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