Senior Systems Integration Engineer

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.If you are passionate about deploying the power of NGS-based diagnostics in clinical care, have a high sense of ownership, and take pride in providing technical leadership to a growing team of Systems Integration Engineers, while continuing to make an individual impact, we would love to speak with you!

As part of a dynamic, flexible company you will be adapting to rapid technological progress and change, and help the team building the platform do the same.The role reports to the Senior Manager, Systems Integration. This role will be an onsite role based in our Brisbane, California headquarters.

What you’ll do:

• 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.
  

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.

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California applicants please review the CCPA Notice at Collection here:

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For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Freenome’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

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