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External Manufacturing Operations Engineer

Siemens Healthineers

📍 Newark, DE

Posted 3 months ago

Quick Info

Experience Level

Mid Level

Minimum Degree

Master

Department

Manufacturing Production
0

Job Type

Full Time

Specialty Skills

Supplier Corrective Action Reports (SCAR)Corrective and Preventative Actions (CAPA)Verification protocolsQualification protocolsValidation protocolsTechnical assessmentsSupplier Change NoticesChange Review Board (CRB)Capital budgetsExpense budgets

About the Role

Serve as the primary liaison with OEM partners for all manufacturing-related activities involving finished products within the Laboratory Systems Business Unit. Ensure adherence to Siemens Healthineers’ Quality Management System. Familiarity with Supplier Corrective Action Reports (SCAR) and Corrective and Preventative Actions (CAPA) is highly desirable. Review and approve verification, qualification, and validation protocols and results conducted at OEM sites, particularly during the commissioning of key equipment and components for Siemens-owned, supplier-operated assets. Lead or coordinate in-house testing when necessary. Provide technical assessments for Supplier Change Notices, including changes to manufacturing processes, raw materials, in-process testing, equipment, and manufacturing locations, in collaboration with Technical Operations. Lead and coordinate escalations of OEM-initiated change notices to the Change Review Board (CRB), including associated documentation and testing. Manage the implementation of Siemens Healthineers-initiated changes at OEM sites. Manage capital and expense budgets for Siemens-owned, supplier-operated equipment. Collaborate with suppliers and Siemens finance teams to ensure assets are properly funded, maintained, and have sufficient capacity. Prepare and submit Applications for Investment (AFIs) as needed.

About Siemens Healthineers

Medical imaging, laboratory diagnostics, and healthcare information technology

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