Maintenance & Reliability Leader – Medical Devices

Exalta Group; Hunters Ridge (FL); On-site; USD 110,000 - 150,000; Full time

Job summary

EXALTA is seeking a Maintenance and Reliability Manager in Bonita Springs, FL to ensure reliability, availability, and performance of manufacturing equipment and facilities in a regulated medical device environment. You will lead preventive and predictive maintenance, improve uptime, and drive continuous improvement initiatives.

The role requires the ability to balance hands-on operational support with long-term planning, lead cross-functional teams, and ensure compliance with FDA, ISO 13485,

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.
• 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.

Responsibilities

• Lead maintenance and reliability activities for manufacturing equipment, utilities, and facility systems.
• Develop and optimize preventive and predictive maintenance programs to improve uptime and reduce downtime.
• Establish and manage reliability metrics (uptime, MTBF, MTTR, PM completion, backlog, recurring failures).
• Lead troubleshooting and root-cause analysis of equipment failures and implement corrective actions.
• Partner with Operations and Engineering to identify constraints and improve performance and reliability.
• Support equipment installation, commissioning, validation, and change-control activities.
• Ensure maintenance activities and documentation comply with FDA, ISO 13485, GMP, and Quality Management System requirements.
• Manage CMMS processes, equipment history, PM records, work orders, and spare-parts inventory.
• Oversee critical facility systems (HVAC, compressed air, electrical, plumbing).
• Manage outside contractors and maintenance service providers.

Skills

Leadership

Maintenance management

Problem solving

Cross-functional leadership

Lean/TPM/5S

Education

Bachelor’s degree in Engineering or related field

Tools

CMMS

Job description

EXALTA is seeking a Maintenance and Reliability Manager in Bonita Springs, FL to ensure reliability, availability, and performance of manufacturing equipment and facilities in a regulated medical device environment. You will lead preventive and predictive maintenance, improve uptime, and drive continuous improvement initiatives.

The role requires the ability to balance hands-on operational support with long-term planning, lead cross-functional teams, and ensure compliance with FDA, ISO 13485,