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.
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.
- Drive the System Reliability program and lead its cross-functional core team.
- Evaluate system performance, proactively identify roadblocks, characterize root causes, and apply analytical problem-solving skills to develop and execute scalable solutions.
- Author and review system-level requirements, test strategies, validation protocols, traceability documentation, technical reports, and other design control documentation.
- Provide subject matter expertise to system-level dFMEA, pFMEA, risk management, hazard assessment, and design review activities.
- Build cross-functional buy-in by clearly communicating opportunities, risks, needs, problems, proposed solutions, and results.
- Provide technical guidance and mentorship to SI engineers.
Must-haves:
- 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.
- 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.
- Experience driving hands-on system integration activities.
- Experience developing and executing system-level test plans and protocols.
- Data analysis expertise and experience with various data analysis software packages.
- Knowledge of SQL, Python, R, or other programming languages.
- Experience analyzing reliability data and coordinating cross-functional investigations.
- 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, and applicable quality system requirements.
Benefits:
- The US target range of our base salary for new hires is $156,750 - $200,025.
- You will also be eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits.