Maintenance & Reliability Manager, Medical Devices

EXALTA; Florida; On-site; USD 110,000 - 170,000; Full time

Job summary

EXALTA is seeking a Maintenance & Reliability Manager for our Bonita Springs, FL facility to ensure reliability, availability, and performance of manufacturing equipment and facility systems in a regulated medical device environment.

You will lead preventive and predictive maintenance, drive continuous improvement, manage CMMS and spare parts, and ensure compliance with FDA/ISO GMP requirements while coaching maintenance staff and leading capital projects.

Qualifications

• Bachelor’s degree in Engineering or related technical discipline.
• 7+ years in maintenance, reliability, or manufacturing engineering with leadership.
• Experience in medical device or other regulated manufacturing environments preferred.
• Experience with preventive and predictive maintenance, CMMS, and root-cause analysis.
• Knowledge of MTBF, MTTR, TPM, and lifecycle management.

Responsibilities

• Lead maintenance and reliability activities for manufacturing equipment, utilities, and facility systems.
• Develop and optimize preventive and predictive maintenance programs to improve equipment uptime and reduce unplanned downtime.
• Establish and manage key reliability metrics, including equipment uptime, MTBF, MTTR, PM completion, maintenance backlog, and recurring equipment failures.
• Lead troubleshooting and root-cause analysis of equipment failures and implement sustainable corrective actions.
• Partner with Operations and Engineering to identify equipment constraints and improve equipment performance, capacity, and reliability.
• Support equipment installation, commissioning, qualification, validation, and change-control activities.
• Ensure maintenance activities and documentation comply with applicable FDA requirements, ISO 13485, GMP, and internal Quality Management System requirements.
• Manage CMMS processes, equipment history, preventive maintenance records, work orders, and spare-parts inventory.
• Oversee critical facility systems, including HVAC, compressed air, electrical, plumbing, and other manufacturing utilities.
• Manage outside contractors, equipment service providers, and preventive maintenance agreements.
• Develop maintenance operating budgets and support capital planning, equipment replacement, and facility improvement projects.
• Partner with Quality and EHS to maintain safe, compliant, and audit-ready operations.
• Lead, coach, and develop maintenance technicians and other assigned personnel.
• Drive Lean, TPM, 5S, and continuous improvement initiatives within the maintenance function.

Skills

Leadership

Cross-functional leadership

Problem-solving

Project management

Lean

TPM

Root-cause analysis

Reliability engineering

CMMS

Lifecycle management

Education

Bachelor’s degree in Engineering

Tools

CMMS

MS Office / Excel

Job description

EXALTA is seeking a Maintenance & Reliability Manager for our Bonita Springs, FL facility to ensure reliability, availability, and performance of manufacturing equipment and facility systems in a regulated medical device environment.

You will lead preventive and predictive maintenance, drive continuous improvement, manage CMMS and spare parts, and ensure compliance with FDA/ISO GMP requirements while coaching maintenance staff and leading capital projects.