Manufacturing Engineer

Job Description

We are seeking a Manufacturing Engineer (Transfer Lead) to support manufacturing process transfers, engineering changes, equipment qualification, validation, and production documentation in a regulated manufacturing environment. The ideal candidate will have strong hands-on experience with Windchill, Gage R&R, control plans, equipment qualification, and Vault DMR updates.

Key Responsibilities

• Manage and review engineering changes, including ECRs, ECNs, BOMs, routers, and work instructions.

• Assess manufacturing process readiness, identify risks, and support implementation activities.

• Support equipment installation, qualification, validation, and decommissioning.

• Assist with validation protocols, execution activities, testing, and report preparation.

• Support MES readiness and manufacturing master data updates.

• Use Windchill to manage engineering documentation and change control activities.

• Support equipment qualification documentation, execution, and traceability using InfoPV.

• Perform Gage R&R studies to evaluate measurement system capability.

• Develop, review, and maintain manufacturing control plans.

• Update Vault DMR records and maintain accurate controlled manufacturing documentation.

• Support quality records, including NCRs, investigation records, and CAPAs.

• Collaborate with Operations and Quality teams to improve manufacturing efficiency, process flow, and manufacturability.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related field.

• Experience in manufacturing engineering within a regulated production environment.

• Strong working knowledge of Windchill and engineering change management.

• Experience with equipment qualification and validation processes.

• Hands-on experience with Gage R&R studies and interpretation.

• Strong knowledge of manufacturing control plans.

• Experience updating Vault DMRs and maintaining controlled documentation.

• Knowledge of ECRs, ECNs, BOMs, routers, and work instructions.

• Experience supporting process changes and cross-functional implementation.