Manager Equipment Service Engineering
Core
Lead equipment lifecycle management, service, and engineering for automation hardware and software in a clinical laboratory setting to support high-throughput production of cancer detection assays.
Role type
Manager, Equipment Service Engineering
Builds
Reliable, compliant laboratory equipment and automation systems for IVD/LDT cancer screening tests
Domain
Clinical Laboratory Operations / Life Sciences / Regulated Manufacturing
Deliverable
infrastructure
Required skills
Laboratory equipment lifecycle management, vendor and service contract management, regulatory compliance (CLIA/CAP/FDA/GxP), cross-functional leadership, high-throughput automation systems expertise, process validation (IQ/OQ/PQ), continuous improvement
Preferred skills
NGS workflow support, reagent manufacturing (cGMP), scaling engineering functions
Technologies
Automated liquid handlers, sequencers, centrifuges, thermal cyclers
Responsibilities
Develop and maintain equipment management policies and SOPs; manage electronic equipment inventory and service records; oversee equipment suppliers and service contracts; establish equipment support strategies and resource plans; partner with Quality, Regulatory, and Automation teams on implementation and validation; provide technical leadership for troubleshooting complex equipment issues; monitor equipment performance metrics and lead continuous improvement; support regulatory inspections and audits; train laboratory personnel on equipment operation.
Seniority
Manager, hands-on IC with people management