Manager, Operations Maintenance

Job Responsibilities

• Lead the maintenance team ensuring all critical manufacturing and facility equipment operates at peak reliability and compliance standards.
• Oversee preventative maintenance (PM) programs, ensuring scheduling effectiveness, timely execution, and minimal production disruption.
• Manage technical resources — including personnel, equipment, and tools — to meet organizational goals for safety, quality, delivery, and cost.
• Prioritize maintenance response to line-down situations and drive rapid, root-cause-based recovery actions.
• Ensure all operations adhere to FDA, ISO 13485, and other applicable medical device and environmental regulations.
• Responsible for developing and/or revising SOP’s/DOP’s and owning quality improvement initiatives (i.e. CAPA, NC, Audit Findings etc.).
• Maintain and continuously improve equipment uptime by developing robust PM and calibration programs.
• Monitor and analyze maintenance KPIs to identify trends, predict potential failures, and implement corrective actions proactively.
• Collaborate with Supply Chain and Engineering teams to maintain optimal critical spare parts inventory and manage vendor relationships effectively.
• Lead failure mode analysis and corrective/preventive maintenance activities to enhance asset reliability and lifespan.
• Manage department budgets in alignment with Annual Operating Plans (AOP) and continuous improvement initiatives.

Cross-Functional Collaboration

• Partner closely with Manufacturing, Quality, Facilities, and Engineering teams to ensure maintenance priorities align with operational objectives.
• Provide technical guidance and support during new equipment installations, validations, and process changes.
• Collaborate with QA, EHS, and Regulatory teams to maintain documentation accuracy and readiness for internal or external audits.
• Communicate equipment and facility status updates regularly to internal stakeholders, ensuring transparency and alignment across functions.

Continuous Improvement

• Identify opportunities to reduce PM costs, improve response time, and enhance maintenance efficiency using Lean and Six Sigma methodologies.
• Develop and revise Standard Operating Procedures (SOPs) to strengthen maintenance consistency and compliance.
• Apply data-driven decision-making to improve equipment performance and reduce downtime.
• Champion initiatives to automate monitoring, streamline work order management, and modernize maintenance systems (e.g., CMMS tools).

People Leadership & Development

• Supervise and mentor a team of Manufacturing Technicians and maintenance personnel, fostering a culture of accountability and professional growth.
• Ensure all staff receive proper training and are equipped to perform maintenance duties safely and effectively.
• Provide regular feedback, recognition, and performance coaching to promote engagement and development.
• Support continuous learning and technical skill advancement within the maintenance organization.

Safety & Compliance

• Maintain a safe work environment by ensuring adherence to all Environmental Health & Safety (EHS) standards and company policies.
• Conduct routine safety audits, equipment inspections, and incident reviews to identify and mitigate risks.
• Promote a proactive safety culture through awareness campaigns, training, and team participation in safety improvement activities.
• Ensure compliance with all regulatory requirements for medical device manufacturing environments, including documentation and reporting protocols.