Manufacturing Engineer

Key Responsibilities:

• Support site Quality records such as NCRs, IEs, and CAPAs.
• 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 InfoPV 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.

Required Qualifications:

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering field.
• Experience in manufacturing engineering within a regulated production environment.
• Strong Windchill knowledge.
• Working knowledge of equipment qualification and 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 supporting process changes, documentation, and cross-functional implementation activities.

Key Skills:

• Manufacturing Engineering
• Windchill
• Equipment Qualification & Validation
• Gage R&R
• Control Plans
• Vault DMR Updates
• ECN/ECR Management
• BOM & Router Maintenance
• MES Readiness
• CAPA / NCR Support
• Technical Documentation
• Cross-Functional Collaboration