Senior Equipment Lifecycle & Lab Automation Manager

DELFI Diagnostics, Inc.; Palo Alto (CA); In loco; USD 135.000 - 165.000; Tempo pieno

Vantaggi offerti da questo lavoro

Flexible time-off policy

401(k) retirement plan

Medical, dental, and vision coverage

Onsite lunch 3 days a week

Descrizione del lavoro

DELFI Diagnostics, Inc. is seeking a Laboratory Operations leader to manage the equipment lifecycle across a clinical laboratory setting.

You will ensure reliability, regulatory compliance, and proper support for automation hardware and software throughout the lifecycle. You will collaborate with Quality, IT, Assay Development, and external suppliers to enable successful launch and sustainment of IVD/LDT assays that improve cancer detection and management.

Competenze

• Experience managing equipment service and engineering programs in regulated production.
• Strong knowledge of instrument qualification, calibration, repair and change control.
• Proven ability to work cross-functionally with Operations, Quality, IT and external suppliers.
• Experience supporting regulatory inspections and audits in CLIA/CAP/GxP environments.
• Experience building or scaling equipment service functions in growing labs.

Mansioni

• Develop, implement, and maintain equipment management policies and processes in line with IVD/LDT quality standards.
• Own the equipment inventory system and ensure accurate qualification, calibration, maintenance, and service records.
• Manage vendors, service contracts, schedules, and escalation of issues; contribute to budget planning.
• Establish support strategies to meet current needs and future capacity.
• Provide technical leadership for troubleshooting and root-cause investigations of equipment issues.
• Support qualification, process validation, and change-control documentation within QMS.

Conoscenze

Equipment lifecycle mgmt

Regulatory compliance

Cross-functional leadership

Vendor management

Troubleshooting complex equipment

High-throughput lab operations

Formazione

B.S. Degree in Life Sciences or Engineering

Descrizione del lavoro

DELFI Diagnostics, Inc. is seeking a Laboratory Operations leader to manage the equipment lifecycle across a clinical laboratory setting.

You will ensure reliability, regulatory compliance, and proper support for automation hardware and software throughout the lifecycle. You will collaborate with Quality, IT, Assay Development, and external suppliers to enable successful launch and sustainment of IVD/LDT assays that improve cancer detection and management.