Senior Systems Integration Engineer

Freenome•Brisbane, CA

21h•$156,750 - $200,025•Onsite

About The Position

Freenome is seeking a Senior Systems Integration Engineer to provide technical leadership and hands-on contribution to the development of next-generation NGS assays and products for early cancer detection. The role is part of a Product Development team developing Freenome’s in vitro diagnostic (IVD) assay portfolio and combines individual technical ownership with leadership and mentorship of Systems Integration Engineers. The engineer will lead functional integration strategy and end-to-end assay workflow execution, system verification and validation, and reliability activities. The role involves evaluating system performance, investigating failures, coordinating mitigation across subsystem owners, and producing design-control documentation. The position reports to the Senior Manager, Systems Integration and is onsite at Freenome’s Brisbane, California headquarters. The US target base salary range for new hires is $156,750–$200,025. The position is also eligible for equity, cash bonuses, and medical, financial, and other benefits, depending on the position offered. Individual compensation may vary based on factors including location, skills, relevant experience, and education. Freenome is an equal-opportunity employer.

Requirements

Bachelor’s degree and 8+ years of relevant work experience, Master’s degree and 6+ years, Doctoral degree and 3+ years, or equivalent experience.
Education or equivalent experience in a relevant field such as Biology, Biochemistry, Bioengineering, Biomedical Engineering, Systems Engineering, Mechanical Engineering, Electrical Engineering, or a related discipline.
Direct experience developing, integrating, or evaluating NGS assays and/or NGS-based diagnostics, including hands-on experience with automated NGS workflows.
Experience with hands-on system integration activities, including assay workflow execution, automation platform operation, system evaluation, troubleshooting, performance characterization, and validation or verification testing.
Experience developing and executing system-level test plans and protocols, including data analysis, interpretation of results, requirements-conformance assessment, failure investigation, and root-cause analysis.
Data-analysis expertise using data analysis software, with well-developed statistical analysis skills and experience with design of experiments (DOE), using JMP, R, or equivalent tools.
Experience analyzing reliability data, identifying recurring failure modes, and coordinating cross-functional investigations and mitigation follow-through.
Direct experience in an FDA-regulated, IVD, medical device, diagnostics, or other regulated product-development environment.
Strong working knowledge of requirements management, design controls, risk management, traceability, technical report authoring, Design History Files, and applicable quality system requirements.
Demonstrated ability to work independently on complex technical assignments, lead key projects, prioritize work based on company objectives and available resources, provide technical guidance, and build cross-functional buy-in.

Nice To Haves

Knowledge of SQL, Python, R, or other programming languages is highly desired.

Responsibilities

Lead functional integration strategy and execute end-to-end assay workflows, system verification and validation activities, and system-level testing while operating automation platforms hands-on.
Define study scope, validation strategies, success criteria, and execution plans independently.
Develop and execute system-level protocols; analyze results against User Needs, Design Input Requirements, and Product Requirements; and communicate conclusions relevant to AV/CV and development exit readiness.
Partner with Development, SW Test Engineering, Automation, and SLIMS teams to align test coverage, entry and exit criteria, and deployment risk-reduction strategies.
Incorporate qualified software releases into Functional Integration and coordinate or execute laboratory deployment and fleet-wide configuration verification.
Drive the System Reliability program and lead its cross-functional core team.
Establish reliability metrics, identify trends in recurring failure modes, prioritize and triage risks, and coordinate mitigation follow-through with accountable subsystem owners.
Lead prioritized technical investigations and communicate improvement opportunities, mitigation status, and resource needs.
Evaluate system performance, identify roadblocks, characterize root causes, and develop and execute scalable solutions for prioritized reagent, workflow, automation, hardware, software, and system integration issues.
Author and review system-level requirements, test strategies, validation protocols, traceability documentation, technical reports, and other design-control documentation within the Design Control framework and Design History Files.
Provide subject matter expertise for system-level dFMEA, pFMEA, risk management, hazard assessment, and design reviews; identify mitigations with accountable subsystem owners to support adequate risk controls.
Build cross-functional alignment by communicating opportunities, risks, needs, problems, proposed solutions, and results in appropriate forums.
Facilitate project debriefs to improve future integration and validation activities.
Provide technical guidance and mentorship to Systems Integration engineers in study design, hands-on execution, troubleshooting, and documentation while retaining ownership of assigned deliverables.