Clear Labs builds an end-to-end, FDA-cleared next-generation sequencing (NGS) diagnostics platform. Our system, Clear Dx, combines automated sample-to-report workflows with an assay menu spanning oncology and infectious disease testing. We're a hands-on team building hardware, software, and wet-lab science together, and we're looking for senior engineers ready to take full ownership of systems, not just advise from the sidelines.
Position Summary
We're hiring a Senior Automation Engineer to strengthen the performance, reliability, and validation of the laboratory automation supporting our FDA-cleared NGS diagnostics platform. This is a hands-on, senior role, you'll be at the deck daily, developing methods, troubleshooting hardware, and contributing to formal validation studies alongside our existing automation team.
Location: San Carlos, CA
Travel: No travel required.
Primary Responsibilities
Contribute hands-on reliability engineering, method development, and troubleshooting expertise for our Hamilton STAR/STAR2 liquid-handling automation fleet running NGS library preparation workflows.
Help design and execute formal automated-vs-manual equivalence and validation studies for NGS sample prep, in support of regulatory requirements.
Support root-cause investigation for automation performance issues affecting NGS library quality and sequencing output, working through mechanical, calibration, and liquid-class variables systematically, and flagging labware-related findings to Systems Integration for formal qualification.
Partner with Regulatory and Quality on validation protocols and documentation for a regulated, FDA-cleared diagnostics workflow.
Collaborate on vendor and equipment relationships as needed to support fleet performance.
Numbers & Facts
Location
San Carlos, CA
Skills
Assaysunmatched
Automationunmatched
Automation Engineeringunmatched
Calibrationunmatched
FDA (Food and Drug Administration)unmatched
Identify Issuesunmatched
Infectious Diseasesunmatched
Laboratory Automationunmatched
Labwareunmatched
Oncologyunmatched
Performance Managementunmatched
Regulationsunmatched
Regulatory Requirementsunmatched
Reliability Engineeringunmatched
Root Cause Analysisunmatched
System Integration (SI)unmatched
Team Buildingunmatched
Validation Documentationunmatched
Validation Planunmatched
Vehicle Fleetsunmatched
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