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

Relocation Assistance Provided: No