Develop, implement, and maintain equipment management policies, SOPs, and processes in accordance with applicable IVD and LDT regulatory and quality requirements.

Own the electronic equipment inventory management system and ensure equipment operation, qualification, calibration, maintenance, repair, and service records are complete, accurate, and maintained in accordance with applicable procedures and quality requirements.

Manage equipment suppliers and service providers, including service contracts, performance expectations, maintenance schedules, and escalation of service issues. Manage equipment-related operating and capital expenditures and contribute to annual budget and capital planning.

Establish equipment support strategies and resource plans to meet current operational needs and future laboratory capacity and scale-up requirements.

Partner with Quality, Regulatory, Assay Development, Automation, IT, and other supporting functions to ensure equipment and automation systems are appropriately implemented and maintained, including qualification, preventive maintenance, calibration, repair, relocation, and decommissioning. Support technology transfer, assay validation, process changes, and implementation of new laboratory equipment and workflows.

Provide technical leadership for troubleshooting complex equipment and automation issues, including investigation of recurring failures and implementation of corrective and preventive actions.

Establish and monitor equipment performance, reliability, downtime, service response, and other key metrics; identify trends and lead continuous improvement initiatives.

Provide input and expertise on equipment selection, installation, qualification, and operational readiness activities for new laboratory equipment and automation systems.

Maintain equipment training programs and ensure laboratory personnel are appropriately trained on the operation and basic troubleshooting of laboratory equipment.

Ensure appropriate equipment qualification, process validation, and change-control documentation is developed and executed, including IQ/OQ/PQ protocols, calibration records, process validation reports, qualification reports, and supporting documentation within our QMS.

Support regulatory inspections and audits by ensuring equipment systems and records remain compliant and inspection-ready.

Support the screening, hiring, onboarding, and development of Clinical Laboratory Assistants (CLAs) with an equipment-focused role to provide day-to-day equipment support and strengthen internal equipment service capabilities.