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Palo Alto, California, United States
Onsite
DELFI Diagnostics, Inc. (DELFI Diagnostics) is developing next-generation, blood-based tests that are reliable, accessible and deliver a new way to help detect cancer. Employing advanced machine-learning methods to whole-genome sequencing data, the DELFI ("DNA EvaLuation of Fragments for early Interception") platform is built to address the highest-burden health challenges. DELFI Diagnostics prioritizes solutions that have the potential to save lives on a global scale, including for historically underserved populations. DELFI Diagnostics’ platform relies on fragmentomics – the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments. FirstLook Lung, for individuals eligible for lung cancer screening, is DELFI Diagnostics’ first laboratory-developed screening test and can be part of routine blood work. FirstLook Lung uses millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early stage disease with a negative predictive value of 99.8 percent. This test has not been cleared or approved by the FDA.
In our passionate pursuit to radically improve health outcomes, we serve humanity when we:
You will be a member of the Laboratory Operations team leading the equipment lifecycle management, service and engineering function for a variety of equipment, automation hardware, and software applications to support production in a Clinical Laboratory setting. You will provide technical and program leadership, ensuring the laboratory equipment is reliable, compliant, and appropriately supported throughout its lifecycle. You will partner cross-functionally with Laboratory Operations, Quality, Regulatory, Assay Development, and external suppliers to support the launch and sustainment of IVD and LDT assays that have the potential to improve how cancer is detected and managed. Through your leadership, you will establish equipment management practices, infrastructure, and technical capabilities that will support DELFI for years to come.
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.
Required
B.S. Degree in Life Sciences, Engineering or related field
At least 8-10 years of combined experience in maintaining and servicing laboratory equipment in a regulated production setting
Experience leading equipment service, laboratory engineering, facilities/equipment, or similar technical programs; direct people-management experience strongly preferred.
Demonstrated experience supporting high-throughput laboratory operations and complex automated laboratory systems.
Strong knowledge of laboratory equipment lifecycle management, including installation, qualification, process validation, preventive maintenance, calibration, repair, change control, relocation, and decommissioning.
Experience managing equipment vendors, service contracts, and external service providers.
Proven ability to work cross-functionally with Laboratory Operations, Quality, Automation/Engineering, Assay Development, IT, and external suppliers.
Strong understanding of the laboratory automation industry and technologies used in high-throughput laboratory operations.
Experience working in a regulated environments: CLIA, CAP, NYS, FDA, ISO and/or GxP
Preferred
Experience supporting NGS laboratory workflows, including automated liquid handlers, sequencers, centrifuges, thermal cyclers, and associated laboratory instrumentation.
Experience in reagent manufacturing, ideally in a regulated environment (cGMP)
Experience supporting regulatory inspections and audits.
Experience building or scaling an equipment service/engineering function in a growing laboratory organization.