Production Engineer – Calibration & Maintenance
Core
Coordinate calibration, preventive maintenance, and lifecycle management of production and test equipment in a regulated medical device manufacturing environment.
Role type
Production Engineer (Calibration & Maintenance)
Builds
Compliant, calibrated, and maintained manufacturing equipment for scanner/system assembly, mechanical/electrical assembly, software configuration, packaging, and testing.
Domain
Medical device manufacturing / Metrology / Quality Management Systems
Required skills
Calibration principles, preventive maintenance coordination, Enterprise Asset Management (EAM) systems, GMP/Quality Management Systems, supplier coordination, controlled procedures, work instructions, risk assessment, audit support, equipment compliance monitoring
Preferred skills
Medical device manufacturing experience, HxGN EAM proficiency, analytical problem-solving, change management processes
Technologies
HxGN EAM, AGORA
Responsibilities
Coordinate site calibration program and schedules; manage internal and external calibration activities; assess and control equipment status; maintain asset records and work orders in EAM; develop calibration procedures and SOPs; coordinate preventive and corrective maintenance; support investigations and audits; monitor performance and drive improvements
Seniority
Mid-level, hands-on IC