Senior Systems Integration Engineer

Freenome•Brisbane, CA

22h•$156,750 - $200,025•Onsite

About The Position

Freenome is seeking a Senior Systems Integration Engineer to provide technical leadership and hands-on contributions to developing next-generation NGS assays and products for early cancer detection. The role is part of a Product Development team of scientists and engineers delivering Freenome’s in vitro diagnostic (IVD) assay portfolio. The engineer will lead functional integration and system reliability activities while continuing to own individual technical deliverables and mentoring other Systems Integration engineers. The position involves planning and executing end-to-end assay workflows, system-level verification and validation, automated platform operation and testing, reliability analysis, root-cause investigations, and design-control documentation. The engineer works cross-functionally with Development, Software Test Engineering, Automation, and SLIMS teams to align test coverage, software releases, deployment readiness, and risk mitigation. The role reports to the Senior Manager, Systems Integration and is onsite at Freenome’s headquarters in Brisbane, California.

Requirements

Bachelor’s degree and 8+ years of relevant work experience, Master’s degree and 6+ years of relevant work experience, Doctoral degree and 3+ years of relevant work experience, 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 driving 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, experience with data-analysis software, and well-developed statistical analysis and design of experiments (DOE) skills 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.
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, automation platform operation, and system-level testing.
Define study scope, validation strategies, success criteria, and execution plans; 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, Software Test Engineering, Automation, and SLIMS to align test coverage, entry and exit criteria, and deployment risk-reduction strategies.
Incorporate qualified software releases into functional integration and coordinate or execute lab deployment and fleet-wide configuration verification.
Drive the System Reliability program and lead its cross-functional core team; establish reliability metrics, trend recurring failure modes, prioritize and triage risks, and coordinate mitigation follow-through with 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.
Communicate opportunities, risks, needs, problems, proposed solutions, and results across functions and 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 maintaining ownership of assigned deliverables.