Production Engineer – Calibration & Maintenance

HC1374 BK Medical ApS; Herlev Kommune; On-site; DKK 523,000 - 710,000; Full time

Job summary

HC1374 BK Medical ApS in Denmark seeks a Production Engineer - Calibration & Maintenance to lead calibration, maintenance, and lifecycle management of production, inspection, and test equipment in a regulated medical device environment. You will work with Manufacturing, Engineering, Quality, and external providers to keep equipment calibrated, compliant, and available for production.

You will coordinate calibration programs, act as SME for EAM systems (HxGN EAM), develop SOPs, and drive

Qualifications

• Bachelor's degree in a relevant engineering or related discipline or equivalent experience.
• Experience with calibration and preventive maintenance in a regulated manufacturing environment.
• Experience with Enterprise Asset Management systems (HxGN EAM preferred).

Responsibilities

• Coordinate site calibration program, including 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.
• 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.
• 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

Analytical skills

Problem solving

Communication

Collaboration

Ownership

Education

Bachelor's degree in Engineering/Manufacturing/Industrial Engineering/Metrology

Tools

HxGN EAM

Job description

Job Description Summary

The Production Engineer - Calibration & Maintenance is responsible for the calibration, maintenance, and lifecycle management of production, inspection, measurement, and test equipment used in a regulated medical device manufacturing environment. The role works closely with Manufacturing, Engineering, Quality, equipment owners, and external service providers to ensure equipment remains calibrated, maintained, compliant, and available for production. Responsibilities include day-to-day calibration and preventive maintenance coordination, HxGN EAM administration, calibration assessments, controlled procedures and work instructions, supplier coordination, and equipment compliance. This is a hands-on Production Engineering role supporting manufacturing operations across scanner/system assembly, mechanical and electrical/electronic assembly, software configuration/loading, packaging and labeling, and testing/final acceptance.

Job Description Roles & 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.

Required Qualifications

Bachelor's degree in Engineering, Manufacturing, Industrial Engineering, Metrology, Maintenance, or a related technical discipline, or equivalent relevant experience. 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.

Desired Characteristics

Experience within medical device manufacturing or another highly regulated manufacturing environment. Strong analytical and problem-solving skills with high attention to detail. Hands-on and practical approach to supporting manufacturing equipment and production operations. Structured working style with strong ownership and ability to manage recurring deadlines. Strong collaboration skills across Manufacturing, Engineering, Quality, Supply Chain, and external suppliers. Clear written and verbal communication skills. Comfortable balancing equipment compliance, production continuity, quality requirements, and operational priorities. Proactive and improvement-focused approach to equipment reliability and calibration/maintenance processes #LI-ONSITE #LI-BJ1

Additional Information

Relocation Assistance Provided: No At GE HealthCare, we see possibilities through innovation. We're partnering with our customers to fulfill healthcare's greatest potential through groundbreaking medical technology, intelligent devices, and care solutions. Better tools enabling better patient care. Together, we are not only building a healthier future but living our purpose to create a world where healthcare has no limits.