Maintenance Manager

Position Summary

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

Key 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.

Qualifications

• 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.
• CRMP – Certified Maintenance & Reliability Technician
• CPIP – Certified Pharmaceutical Industry Professional certification

Key Competencies

• Leadership & Team Development
• Preventive & Predictive Maintenance
• Injection Molding Machine Maintenance
• Automation & Robotics Maintenance
• Safety & Analytical Skills