Calibration & Maintenance Production Engineer

GE HealthCare (United States); København; On-site; DKK 600,000 - 850,000; Full time

Job summary

GE HealthCare is seeking a Production Engineer – Calibration & Maintenance to manage calibration, maintenance, and lifecycle management of production equipment in a regulated medical device environment. The role partners with Manufacturing, Engineering, Quality, and suppliers to ensure equipment remains calibrated, compliant, and available for production.

The position covers hands-on calibration, preventive maintenance, EAM administration, and collaboration with SMEs to optimize equipment

Qualifications

• Bachelor's degree in Engineering, Manufacturing, Industrial Engineering, Metrology, Maintenance, or related technical discipline.
• Experience with calibration, preventive maintenance, equipment management, or Production Engineering in a regulated manufacturing environment.
• Understanding of calibration principles, equipment control, documentation, traceability, and manufacturing process requirements.
• Experience with computerized maintenance or Enterprise Asset Management systems, preferably HxGN EAM or comparable systems.
• Experience working within controlled procedures, work instructions, and change management processes.
• Experience coordinating suppliers, service activities, quotations, and purchase orders.
• Knowledge of GMP and Quality Management System requirements within regulated manufacturing.

Responsibilities

• Coordinate the site calibration program, including calibration schedules, call-in activities, equipment status, due dates, and timely completion.
• Coordinate internal and external calibration activities, including equipment preparation, shipment, return, documentation review, and release back to production.
• Ensure new, returned, overdue, failed, or out-of-tolerance equipment is appropriately assessed and controlled before use.
• Act as SME for calibration and maintenance activities in HxGN EAM, maintaining asset records, calibration setups, preventive maintenance schedules, work orders, task plans, and supporting documentation.
• Perform and support calibration assessments, including equipment requirements, criticality, acceptance criteria, calibration methods, frequencies, and maintenance needs.
• Develop and maintain calibration and maintenance procedures, SOPs, and work instructions in collaboration with equipment owners, SMEs, and Quality.
• Coordinate preventive and corrective maintenance activities for production and test equipment while minimizing disruption to manufacturing.
• Support investigations, risk assessments, and product-impact assessments related to overdue, failed, or out-of-tolerance equipment, and provide input to NC/INV/CAPA activities where applicable.
• Coordinate external calibration and maintenance suppliers, including quotations, service activities, documentation, and AGORA purchase orders.
• Support internal and external audits by ensuring calibration and maintenance records are complete, traceable, compliant, and audit-ready.
• Monitor calibration and maintenance performance and drive improvements in equipment compliance, availability, data quality, and execution efficiency.

Skills

Calibration

Preventive Maintenance

Equipment Management

GMP Knowledge

Change Management

Supplier Coordination

Documentation & Traceability

Audit Readiness

Cross-functional Collaboration

Education

Bachelor's degree in Engineering or related field

Tools

HxGN EAM

Job description

GE HealthCare is seeking a Production Engineer – Calibration & Maintenance to manage calibration, maintenance, and lifecycle management of production equipment in a regulated medical device environment. The role partners with Manufacturing, Engineering, Quality, and suppliers to ensure equipment remains calibrated, compliant, and available for production.

The position covers hands-on calibration, preventive maintenance, EAM administration, and collaboration with SMEs to optimize equipment