Manufacturing Engineer

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

Responsibilities:

• The Manufacturing Engineer supports process readiness, engineering changes, equipment activities, work instruction development, and manufacturing system implementation to ensure efficient and compliant site operations.
• 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 Windchillto review, manage, and support engineering documentation and change activity.
• Support InfoPV equipment qualification activities, including documentation, execution support, and traceability.
• Apply Gage R&Rmethods to evaluate measurement system capability and support process controls.
• Develop, review, and maintain control plansto ensure manufacturing process consistency and compliance.
• Support Vault DMR updatesand maintain accuracy of controlled manufacturing records and related documentation.
• Partner with Operations and Quality to improve flow, efficiency, and manufacturability.

Requirements:

• This role requires strong Windchill knowledge, Equipment qualification/validation knowledge, Gage R&R experience, control plan knowledge, and Vault DMR update knowledge to support documentation accuracy, qualification activities, manufacturing controls, and design/manufacturing change execution.
• 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&Rstudies and interpretation.
• Strong control plan knowledge.
• Experience with Vault DMR updates and controlled document maintenance.
• Experience with process changes, documentation, and cross-functional implementation

Why Should You Apply?

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