Manufacturing Engineer

Location: Warsaw, IN 46580
Duration: 12 Months
Job Type: Contract

Job Summary

We are seeking a Manufacturing Engineer to support manufacturing process readiness, engineering changes, equipment qualification, manufacturing documentation, and process improvement activities within a regulated production environment.

The ideal candidate will have strong experience with Windchill, equipment qualification/validation, Gage R&R, Control Plans, and Vault DMR documentation, along with hands-on experience supporting manufacturing changes and cross-functional implementation.

Key Responsibilities

• Support manufacturing process readiness, risk assessments, and implementation activities.
• Review and manage ECRs, ECNs, BOM updates, routers, and work instructions.
• Support site quality records including NCRs, IE''''''''s, and CAPAs.
• Perform process walks to evaluate manufacturing readiness and identify implementation needs.
• Support equipment installation, qualification, validation, and decommissioning activities.
• Assist with creation and execution of qualification/validation protocols and related reports.
• Support MES readiness and manufacturing master data activities.
• Use Windchill to manage engineering documentation and engineering change activities.
• Support InfoPV equipment qualification, including documentation, execution, and traceability.
• Apply Gage R&R methods to evaluate measurement system capability and support process controls.
• Develop, review, and maintain Control Plans for manufacturing processes.
• Support Vault DMR updates and maintain accurate controlled manufacturing records.
• Partner with Operations, Quality, and Engineering teams to improve manufacturing flow, efficiency, and manufacturability.

Required Qualifications

• Bachelor''''''''s degree in Mechanical, Manufacturing, Industrial Engineering, or a related engineering field.
• Experience in Manufacturing Engineering within a regulated production environment.
• Strong Windchill experience.
• Experience with equipment qualification and validation processes and documentation.
• Hands-on experience with Gage R&R studies and interpretation.
• Strong knowledge of Control Plans.
• Experience with Vault DMR updates and controlled document maintenance.
• Experience supporting process changes, engineering documentation, and cross-functional implementation.