Production Engineer – Calibration & Maintenance

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

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Additional Information