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.
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; 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 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.
Benefits and additional information
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 depending on the position offered. Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.
Freenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
Applicants have rights under Federal Employment Laws.
Family & Medical Leave Act (FMLA)
Equal Employment Opportunity (EEO)
Employee Polygraph Protection Act (EPPA)
California applicants please review the CCPA Notice at Collection here:
California Consumer Privacy Act (CCPA)
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