Sr Manufacturing Engineer

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