Maintenance Manager
Core
Manage maintenance operations, equipment validation, and safety compliance for medical device manufacturing facilities to ensure production schedules are met with quality and efficiency.
Role type
Senior Maintenance Manager (Medical Device Manufacturing)
Builds
Medical device manufacturing facilities and production lines
Domain
Medical Devices / Manufacturing / Quality Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechanical/Electronic/Electromechanical engineering, equipment validation, ISO 13485 & FDA/GMP compliance, preventive and corrective maintenance, team supervision, budget administration, safety leadership, inventory management, problem-solving techniques
Preferred skills
Equipment transfer experience, ISO 14001 knowledge, building installations experience
Technologies
Common computer software packages
Responsibilities
Verify equipment installation and validation before usage; investigate and fix recurring equipment malfunctions; develop and sustain training programs for new personnel and operators; supervise daily department activities and hire personnel; approve quality system documents; implement preventive and corrective actions for processes and clean rooms; manage spare parts inventory to avoid production stoppages; lead safety activities and ensure compliance with company and government safety rules; participate in annual budget setup for manufacturing and facilities.
Seniority
Senior, hands-on IC with management responsibilities
