Objective:

Responsible for leading maintenance and facilities activities to ensure safe, reliable, compliant, and efficient operation of manufacturing equipment, cleanroom infrastructure, building systems, utilities, and related assets within a medical device manufacturing environment. Responsible for supporting departmental strategies, objectives, and key performance indicators (KPIs) that support company goals, regulatory requirements, equipment reliability, cost controls, and continuous improvement initiatives.

Responsibilities and Essential Functions:

• Develop processes to promote cross functional teamwork and the best use of existing competencies.
• Responsible for developing talent in direct reports.
• Responsible for resolving conflicts involving direct reports.
• Responsible for achieving the goals of Ambu as a whole.
• Facilitates regular communication and meetings with direct reports.
• Responsible for ensuring information is communicated to direct reports and the rest of the organization when necessary.
• Responsible for attaining the annual operating budget and is accountable for departmental expenditures within approved budgetary guidelines.
• Responsible for directing preventive, predictive, corrective, and emergency maintenance activities for manufacturing equipment, facilities, and utility systems.
• Responsible for developing, implementing, and maintaining maintenance programs that maximize equipment uptime and asset reliability.
• Responsible for creating annual departmental objectives and ensuring alignment with site and corporate strategic goals.
• Responsible for establishing, monitoring, analyzing, and reporting departmental Key Performance Indicators (KPIs)
• Responsible for identifying opportunities for continuous improvement and driving corrective actions to achieve established objectives and performance targets.
• Responsible for maintaining an effective Computerized Maintenance Management System (CMMS) program.
• Responsible for ensuring maintenance activities support compliance with FDA, ISO 13485, OSHA, environmental, and company requirements.
• Support coordinating maintenance contractors, suppliers, and service providers.
• Responsible for supporting equipment installations, facility modifications, validation activities, and capital projects.
• Responsible for ensuring facilities, building systems, HVAC systems, compressed air systems, electrical systems, water systems, and other utility systems operate safely and efficiently.
• Responsible for maintaining inspection readiness for maintenance documentation and records.
• Responsible for promoting a culture of safety, accountability, operational excellence, and continuous improvement.
• All other duties as assigned.

Qualifications:

• Bachelor’s degree in a related field preferred; an equivalent combination of relevant education and work experience will be considered.
• Five years' experience in maintenance support in a manufacturing environment.
• Five years' experience leading maintenance personnel.
• Five years' experience working in the medical device field preferred.
• Ability to support departmental KPI and objective tracking and identify the appropriate sources for required information.
• Experience supporting maintenance budgets and capital projects.
• Experience with CMMS systems.
• Knowledge of FDA, ISO 13485, OSHA, and applicable regulatory requirements.
• Strong leadership, communication, organizational, and problem-solving skills.
• Must be able to speak, read, write and understand English.

Ambu provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.