Manufacturing Engineer

Our Client, a Medical Devices / Healthcare company, is looking for a Manufacturing Engineer for their Warsaw, IN location.
 
Responsibilities:

• Support site Quality records such as NCR's, IE's, and CAPA's.
• Own and Review ECRs, ECNs, routers, BOM updates, and work instructions.
• Walk processes to assess readiness, risks, and implementation needs.
• Support equipment installation, qualification, validation, and decommissioning activities.
• Assist with protocol creation, execution support, and report activities tied to manufacturing changes.
• Support MES readiness and manufacturing master data activities.
• Use Windchill to review, manage, and support engineering documentation and change activity.
• Support Info PV equipment qualification activities, including documentation, execution support, and traceability.
• Apply Gage R & R methods to evaluate measurement system capability and support process controls.
• Develop, review, and maintain control plans to ensure manufacturing process consistency and compliance.
• Support Vault DMR updates and maintain accuracy of controlled manufacturing records and related documentation.
• Partner with Operations and Quality to improve flow, efficiency, and manufacturability.

• Bachelor’s degree in Mechanical, Manufacturing, Industrial, or related engineering field.
• Experience in manufacturing engineering in a regulated production setting.
• Strong Windchill knowledge.
• Working knowledge of equipment qualification/validation processes and documentation.
• Experience with Gage R &R studies and interpretation.
• Strong control plan knowledge.
• Experience with Vault DMR updates and controlled document maintenance.
• Experience with process changes, documentation, and cross-functional implementation.

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities