Maintenance and Reliability Manager

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Maintenance and Reliability Manager

Management Regular Full-Time Bonita Springs, FL, US

EXALTA is seeking a Maintenance & Reliability Manager who will be responsible for ensuring the reliability, availability, and performance of manufacturing equipment and facility systems within a regulated medical device manufacturing environment at our Bonita Springs, FL manufacturing facility!

This role leads preventive and predictive maintenance, equipment reliability, facilities maintenance, and continuous improvement initiatives to minimize downtime and support safe, compliant, and efficient operations.

Key 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.

Qualifications

• Bachelor’s degree in Engineering, Manufacturing, Facilities Management, or related technical discipline preferred; equivalent technical experience considered.
• 7+ years of maintenance, reliability, or manufacturing engineering experience, including leadership responsibility.
• Experience in medical device, pharmaceutical, aerospace, or another highly regulated manufacturing environment strongly preferred.
• Demonstrated experience with preventive and predictive maintenance, CMMS systems, equipment troubleshooting, and root-cause analysis.
• Working knowledge of reliability methodologies, including MTBF, MTTR, TPM, and equipment lifecycle management.
• Experience supporting equipment qualification, validation, and controlled manufacturing processes preferred.
• Strong project management, problem-solving, and cross-functional leadership skills.
• Ability to balance hands-on operational support with longer-term reliability and capital planning.

Why Join EXALTA?

At EXALTA, we partner with leading medical technology companies to bring life-changing products to market. You will play a key role in building a culture of continuous improvement, enabling scalable growth, and helping deliver our mission: Together, we make MedTech better.

EXALTA is an Equal Opportunity Employer. We respect every employee as an individual, and we hire and promote based on qualifications, performance, and potential - without regard to race, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.