Senior NGS Systems Integration Lead

Freenome; Brisbane (CA); On-site; USD 157,000 - 200,000; Full time

Job summary

Freenome is hiring a Senior Systems Integration Engineer to provide technical leadership and drive hands on contribution to the development of next generation NGS assays/products for early cancer detection. You will work in a Product Development team of world-class Scientists and Engineers focused on delivering Freenome’s IVD assay portfolio.

The role reports to the Senior Manager, Systems Integration and is an onsite role based in Brisbane, California.

Qualifications

• Bachelor’s degree with 8+ years of relevant work experience, Master’s degree with 6+ years of relevant work experience, or Doctoral degree with 3+ years of relevant work experience; or equivalent experience.
• Education or equivalent experience in Biology, Biochemistry, Bioengineering, Biomedical Engineering, Systems Engineering, Mechanical Engineering, Electrical Engineering, or 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 test results, assessment of requirements conformance, failure investigation, and root cause analysis.
• Data analysis expertise and experience with various data analysis software packages, including well developed statistical analysis skills and design of experiments (DOE), using JMP, R, or equivalent tools. Knowledge of SQL, Python, R, or other programming languages is highly desired.
• Experience analyzing reliability data, identifying recurring failure modes, and coordinating cross functional investigations and mitigation follow through.
• Direct experience working 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 operate independently on complex technical assignments, lead key projects, prioritize work based on company objectives and available resources, provide technical guidance to others, and build cross functional buy in.

Responsibilities

• Lead Functional Integration strategy and execute end to end assay workflows, system verification and validation activities while maintaining a strong hands on role in automation platform operation and system level testing.
• Independently 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 to inform AV/CV and development exit readiness.
• Partner with Development, SW Test Engineering, Automation, and SLIMS to align test coverage, entry and exit criteria, and deployment derisking 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 accountable subsystem owners. Lead prioritized technical investigations and communicate improvement opportunities, mitigation status, and resource needs.
• Evaluate system performance, proactively identify roadblocks, characterize root causes, and apply analytical problem solving skills to 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 to system level dFMEA, pFMEA, risk management, hazard assessment, and design review activities; identify hardware, firmware, software, workflow, and process mitigations with accountable subsystem owners to support adequate risk control measures.
• Build cross functional buy in by clearly communicating opportunities, risks, needs, problems, proposed solutions, and results in the appropriate forums. Facilitate project debriefs to improve future integration and validation activities.
• Provide technical guidance and mentorship to SI engineers in study design, hands on execution, troubleshooting, and documentation while maintaining individual ownership of assigned deliverables.

Skills

NGS assays

System integration

Automation platform operation

DOE

Statistical analysis

SQL

Python

R

Data analysis

Regulated IVD / FDA exposure

Education

Bachelor’s degree in a relevant field

Master’s degree in a related field

Doctoral degree with relevant experience

Tools

JMP

Python

R

SQL

Job description

Freenome is hiring a Senior Systems Integration Engineer to provide technical leadership and drive hands on contribution to the development of next generation NGS assays/products for early cancer detection. You will work in a Product Development team of world-class Scientists and Engineers focused on delivering Freenome’s IVD assay portfolio.

The role reports to the Senior Manager, Systems Integration and is an onsite role based in Brisbane, California.