Maintenance Manager

Ompi of America Inc•Fishers, IN

About The Position

This role ensures the reliability, safety, and compliance of all equipment and systems, supporting uninterrupted production and adherence to medical device regulations.

Requirements

Bachelor’s degree in engineering, Maintenance Management, or related field (preferred).
5+ years of experience in maintenance management within a regulated environment, medical device experience a plus.
Strong knowledge of injection molding equipment, automated assembly systems (robotics, PLCs, vision systems), and cleanroom operations.
Experience with Lean Manufacturing, TPM, or similar methodologies.
Excellent leadership, communication, and problem-solving skills.
Proficiency with Computerized Maintenance Management Systems, ERP/MRP systems, and Microsoft Office Suite.

Nice To Haves

medical device experience a plus

Responsibilities

Maintenance Oversight: Plan, schedule, and supervise preventive and corrective maintenance for injection molding machines, automated assembly lines, robotics, material handling systems, and auxiliary equipment.
Ensure all equipment operates efficiently and meets regulatory and quality standards for medical device manufacturing.
Regulatory & Quality Compliance: Maintain documentation and validation of maintenance activities in compliance with ISO 13485, FDA, GMP, and other relevant medical device regulations.
Support audits and inspections by providing accurate maintenance records and ensuring equipment calibration and validation.
Team Leadership: Lead, train, and develop a team of maintenance technicians, automation specialists, and support staff.
Foster a culture of safety, accountability, and continuous improvement.
Cleanroom & Environmental Control: Oversee maintenance of cleanroom environments, HVAC, and environmental monitoring systems to ensure compliance with contamination control protocols.
Train staff on cleanroom maintenance procedures and monitor adherence.
Process & Equipment Improvement: Identify and implement improvements to increase equipment reliability, reduce downtime, and optimize maintenance costs (Lean, TPM, Six Sigma, etc.).
Analyze equipment performance data to drive continuous improvement initiatives.
Health, Safety & Compliance: Enforce compliance with health, safety, and environmental regulations, especially regarding automated machinery and cleanroom environments.
Lead safety meetings, risk assessments, and incident investigations related to maintenance activities.
Resource & Asset Management: Manage spare parts inventory, maintenance budgets, and vendor relationships.
Coordinate with production and engineering to support new equipment installation, commissioning, and validation.
Reporting & Communication: Prepare and present maintenance performance reports, metrics, and improvement plans to senior management.
Maintain accurate records of maintenance activities, downtime, and equipment performance.