Function: Manufacturing Engineering / Operations Transformation Department / Reports to / Location: To be assigned
Role purpose
Support process readiness, engineering changes, equipment activities, work-instruction development, and manufacturing-system implementation to enable efficient, controlled site operations.
Key responsibilities
Review engineering change requests and notices, routers, bills of material, and work instructions; walk processes to assess readiness, risks, and implementation needs.
Support equipment installation, qualification, and decommissioning, including protocol preparation, execution support, and reporting for manufacturing changes.
Support MES readiness and manufacturing master-data activities; use Windchill to review engineering documentation and change activity.
Support equipment qualification activities in InfoPV and maintain or update Vault device master records as assigned.
Develop, review, and maintain control plans; perform or interpret Gage R&R studies and work with Operations and Quality to improve process flow and manufacturability.
Baseline qualifications
Engineering degree required.
2-5 years of medical device experience required.
Experience in manufacturing engineering in a regulated production setting.
Strong Windchill knowledge; working knowledge of InfoPV equipment qualification and Vault device master record updates.
Experience with Gage R&R, control plans, process changes, documentation, and cross-functional implementation.
Preferred experience
Experience supporting MES readiness, manufacturing master data, equipment qualification, or site transformation activities.
