Manager Equipment Service Engineering

DELFI Diagnostics, Inc.•Palo Alto, CA

2d•$135,000 - $165,000

About The Position

DELFI Diagnostics is developing next-generation, blood-based tests to help detect cancer. The company utilizes advanced machine-learning methods and fragmentomics to analyze cell-free DNA (cfDNA) fragments. Their first test, FirstLook Lung, is designed for individuals eligible for lung cancer screening. DELFI Diagnostics is committed to creating solutions that can save lives globally, especially for underserved populations. This role is within the Laboratory Operations team, focusing on equipment lifecycle management, service, and engineering for various equipment, automation hardware, and software applications supporting clinical laboratory production. The position requires technical and program leadership to ensure laboratory equipment is reliable, compliant, and well-supported throughout its lifecycle. Collaboration with Laboratory Operations, Quality, Regulatory, Assay Development, and external suppliers is essential for supporting the launch and sustainment of IVD and LDT assays.

Requirements

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
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

Nice To Haves

Direct people-management experience strongly 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.

Responsibilities

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.
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.
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.
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.