Equipment Lifecycle Lead – Lab Operations & Compliance

Delfidiagnostics; Palo Alto (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

DELFI Diagnostics, Inc. in Palo Alto is seeking a senior Laboratory Equipment Manager to lead the equipment lifecycle management for a range of automation hardware and software in a Clinical Laboratory setting.

You will provide technical leadership, ensure compliant operation, qualification, maintenance, and service records, and partner with Quality, Regulatory, Assay Development, IT, and external suppliers to support launch and sustainment of IVD and LDT assays.

Qualifications

• 8–10 years of experience maintaining and servicing laboratory equipment in regulated production.
• Experience leading equipment service, engineering, or similar technical programs; people management preferred.
• Experience supporting high-throughput laboratory operations and automated systems.
• Strong knowledge of equipment lifecycle management (installation, qualification, maintenance, calibration, change control).

Responsibilities

• Develop and implement equipment management policies and SOPs in line with IVD/LDT requirements.
• Own and maintain the electronic equipment inventory and qualification records.
• Manage equipment vendors, service contracts, and budgets; plan capital expenditures.
• Establish equipment support strategies to meet current and future lab capacity.
• Collaborate with Quality, Regulatory, IT, and Assay Development for implementation and validation.
• Provide technical leadership for troubleshooting complex equipment and automation issues.
• Monitor performance metrics and drive continuous improvement.
• Lead equipment qualification and validation documentation (IQ/OQ/PQ).
• Support regulatory inspections and audits; assist with hiring/training of CLAs dedicated to equipment support.

Skills

Equipment lifecycle management

Leadership / people management

Cross-functional collaboration

High-throughput lab operations

Regulatory compliance

Education

B.S. in Life Sciences or Engineering

Tools

Vendor management

Job description

DELFI Diagnostics, Inc. in Palo Alto is seeking a senior Laboratory Equipment Manager to lead the equipment lifecycle management for a range of automation hardware and software in a Clinical Laboratory setting.

You will provide technical leadership, ensure compliant operation, qualification, maintenance, and service records, and partner with Quality, Regulatory, Assay Development, IT, and external suppliers to support launch and sustainment of IVD and LDT assays.