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Salary: USD 160,808 - 196,544 / annual
Clear Labs builds an FDA-cleared next-generation sequencing (NGS) diagnostics platform called Clear Dx, combining automated sample-to-report workflows with assays spanning oncology and infectious disease testing. The company is seeking a Systems Integration Lead to serve as the technical bridge between assay science and automation engineering.
In this hands-on senior role, you will own the full lifecycle of process automation: translating benchtop assays into production-compatible automated workflows, qualifying labware, designing robustness testing and guardbanding, and executing acceptance criteria and verification/validation protocols as processes move from bench to production. Key responsibilities include driving on-deck integration of sequencing into oncology workflows (currently a manual, off-deck step), leading technical evaluation and integration of new NGS platforms (Illumina, Oxford Nanopore) and library prep chemistries, and serving as the technical bridge between wet-lab scientists and automation engineers. You will also partner with Regulatory and Quality to ensure all system and workflow changes are appropriately validated for the FDA-cleared diagnostics environment, and lead technical diligence on new sequencer, automation, and reagent vendor partnerships.
This role reports directly to the COO/CSO and is based in San Carlos, CA with no travel required. You will be expected to work hands-on at the bench, building and testing systems yourself rather than advising from the sidelines.
REQUIREMENTS:
- 8+ years of hands-on process/automation engineering or systems integration experience in diagnostics, medical device, or regulated laboratory environments
- Working knowledge of FDA design-control and 510(k) considerations as they apply to system, workflow, and labware changes
- Prior experience in oncology diagnostics (companion diagnostics, comprehensive genomic profiling, or MRD workflows) strongly preferred
- Strong cross-functional communication skills; comfortable translating between bench scientists and automation/hardware engineers
- Genuine preference for hands-on, at-the-bench work over slide review
TECHNICAL SKILLS — NGS:
- Hands-on experience with at least one major NGS sequencing platform (Illumina and/or Oxford Nanopore), including run setup, sequencing chemistry, and flow cell/consumable workflows
- Working knowledge of NGS library preparation chemistries relevant to clinical panels (hybrid capture and/or amplicon-based enrichment)
- Experience integrating or supporting a secondary analysis pipeline (e.g., DRAGEN or equivalent) and understanding how upstream lab changes propagate to sequencing QC metrics and analysis output
- Familiarity with NGS assay QC parameters and how automation or platform changes affect them
TECHNICAL SKILLS — AUTOMATION, LABWARE & SYSTEMS ROBUSTNESS:
- Hands-on experience with Hamilton STAR/STAR2 liquid handling platforms, including VENUS software, deck design, and integrating third-party modules
- Demonstrated experience in labware selection, qualification, and DOE-based robustness testing (tolerance analysis, failure-mode analysis) for automated liquid-handling processes
- Strong statistical skills (design of experiments, process capability analysis, hypothesis testing, tolerance stack-up) applied to robustness and verification/validation study design
- Track record translating manual, research-originated wet-lab protocols into production-grade, automatable, robust processes suitable for regulated environments
- Understanding of how liquid-handling method design and labware selection affect downstream NGS library quality and sequencing performance
