Production Calibration & Maintenance Engineer

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

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