Senior System Engineer

Spencer Rigby Ltd.; California; On-site; USD 150,000 - 190,000; Full time

Job summary

Spencer Rigby Ltd. in California partners with a rapid-growth molecular diagnostics company to build a senior systems engineer role that bridges assay development and automation.

The candidate will convert bench protocols into scalable, reliable production processes on an automated platform, own labware qualification, and drive verification studies while aligning with FDA requirements and production timelines.

Qualifications

• Experience scaling lab protocols to automated production.
• Familiarity with FDA design controls and validation.
• Experience with verification and validation studies.
• Knowledge of library preparation workflows in NGS.

Responsibilities

• Convert bench protocols into reliable production-ready processes for automation.
• Qualify labware, set operating margins, and run FMEA to ensure dependable steps.
• Lead sequencing automation within the oncology workflow end-to-end.
• Evaluate new sequencing instruments and onboard vendor partnerships.
• Plan verification/validation studies as workflows transition to production.
• Coordinate with Regulatory/Quality for proper validation and documentation.

Skills

Lab automation

Process scaling

Systems integration

NGS sequencing

Regulatory knowledge

Design of experiments

Tools

Hamilton STAR/STAR2

VENUS programming

Illumina sequencing

Oxford Nanopore sequencing

Job description

Spencer Rigby has partnered with a fast-growing molecular diagnostics company that has developed a fully automated, FDA-cleared oncology sequencing platform, taking clinical samples all the way through to final report.

With engineering, software, and laboratory science working side by side, the company is building a small, highly capable team of senior engineers who want to own what they build and see it through to production.

As Senior Systems Engineer, you will connect the worlds of assay development and automation, converting bench-developed protocols into scalable, reliable processes that run on the company's automated platform. You will be accountable for labware choice and qualification, process robustness, and the testing that proves each workflow is ready for production, while leading the effort to bring sequencing fully onto the automated oncology workflow for the first time.

What You'll Do

• Work with the assay science team to re-engineer manual bench protocols into reliable, production-ready processes that can run on an automated system
• Select and qualify labware, set operating margins, and run designed experiments and failure-mode analysis to make every automated step dependable
• Lead the move of sequencing from a standalone manual step into the automated oncology workflow, creating a truly end-to-end process
• Evaluate and onboard new sequencing instruments and library preparation chemistries, and provide independent technical review of vendor partnerships, timelines, and effort estimates
• Set acceptance criteria and plan and run verification and validation studies as workflows transition into production
• Translate between laboratory scientists and automation engineers, working with Regulatory and Quality to keep all changes properly validated and documented under FDA requirements

Requirements

• 8+ years of practical experience in process engineering, automation, or systems integration within diagnostics, medical devices, or another regulated lab setting (8-10+ years for a Principal-level appointment)
• Proven ability to take early-stage or research-based laboratory methods and scale them into robust, automated production processes
• Hands-on expertise with Hamilton STAR/STAR2 liquid handlers, including VENUS programming, deck layout, and integration of third-party modules, plus direct experience running Illumina and/or Oxford Nanopore sequencers
• Solid understanding of clinical NGS library preparation (hybrid capture or amplicon-based), secondary analysis pipelines such as DRAGEN, and how changes upstream in the lab influence sequencing quality metrics
• Strong grounding in applied statistics, including designed experiments, process capability, and tolerance analysis, alongside a working knowledge of FDA design controls and 510(k) requirements
• Background in oncology diagnostics such as companion diagnostics, comprehensive genomic profiling, or MRD is highly desirable
• A hands-on engineer who enjoys building and testing systems personally rather than overseeing from a distance