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Senior Software Quality Engineer
KariusRedwood City, United StatesRemotefull_timeVerifiedPosted 31 Aug 2025
About the role
About KariusKarius is a venture-backed life science startup that is transforming the way pathogens and other microbes are observed throughout the body. By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challenging cases, providing industry partners with access to 1000’s of biomarkers to accelerate clinical trials, discovering new microbes, and reducing patient suffering worldwide.
Position SummaryWe are seeking a Senior Software Quality Engineer to ensure the quality, performance, and compliance of the analytical software system at Karius. We develop and operate AI-driven data analytics pipelines to deliver life-saving results in the highly complex infectious disease landscape. In this role, you will collaborate closely with software engineers, product managers, and technical stakeholders throughout the software lifecycle to develop and execute comprehensive test plans and procedures. Your contributions will directly impact the accuracy, efficiency, and reliability of the Karius system, enabling Karius to better provide actionable insights to physicians for patient treatment.
Why Should You Join Us?Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company’s platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The Karius test we provide today is one of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our test is the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale.
Reports to: Director, Analytical Systems and Data Insights
Location: Redwood City, CA (Hybrid) or Remotely (US only)
Primary ResponsibilitiesSoftware Testing and Validation • Collaborate with software engineers, product managers, and technical stakeholders to understand system functionality, identify testable requirements, and resolve issues.• Develop, execute, and maintain comprehensive test plans, test cases, and test scripts to validate bioinformatics software functionality, performance, and compliance.• Perform manual and automated testing (e.g. functional, integration, regression, system testing) to ensure alignment with software requirements, risk assessments, and quality standards.• Identify and implement improvements to testing processes, methodologies, and tools (e.g. automated test frameworks, quality metrics tracking) to enhance software quality and team productivity.
Regulatory Compliance and Risk Management• Ensure all testing activities comply with applicable IVD and/or LDT regulations (e.g. 21 CFR Part 11, 21 CFR Part 820, CAP/CLIA, NYS DOH, IVDR) and standards (e.g. IEC 62304, ISO 13485, ISO 14971).• Maintain awareness of data privacy and security frameworks (e.g. HIPAA, SOC II, GDPR) to align with compliance needs.• Develop and maintain traceability matrices linking test cases to software requirements, risk analyses, and design inputs/outputs.• Contribute to software risk assessments and hazard analyses (e.g. FMEA) to identify and mitigate potential risks to patient safety.• Support the preparation of documentation for design reviews, regulatory submissions, and audits.
What’s Fun About the Job?Karius is operating at the edge of what is now known to be possible in infectious disease diagnostics. With that, comes a wave of new and incredible challenges and opportunities. To deliver on that value, you will be tapping into some of the most advanced technologies, architecting and innovating where the current solutions simply don't suffice. You will get to see how much your work really matters.
Travel: Travel required up to 10% to headquarters for team meetings.
Physical RequirementsSubject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office environment.
Position Requirements• Bachelor's degree (or M.S. degree) in Computer Science, Software Engineering, Electrical Engineering, Bioengineering, Bioinformatics, or related technical fields involving algorithms or coding (e.g., Physics or Mathematics).• 5+ years of experience in software quality engineering, with
Position SummaryWe are seeking a Senior Software Quality Engineer to ensure the quality, performance, and compliance of the analytical software system at Karius. We develop and operate AI-driven data analytics pipelines to deliver life-saving results in the highly complex infectious disease landscape. In this role, you will collaborate closely with software engineers, product managers, and technical stakeholders throughout the software lifecycle to develop and execute comprehensive test plans and procedures. Your contributions will directly impact the accuracy, efficiency, and reliability of the Karius system, enabling Karius to better provide actionable insights to physicians for patient treatment.
Why Should You Join Us?Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company’s platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The Karius test we provide today is one of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our test is the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale.
Reports to: Director, Analytical Systems and Data Insights
Location: Redwood City, CA (Hybrid) or Remotely (US only)
Primary ResponsibilitiesSoftware Testing and Validation • Collaborate with software engineers, product managers, and technical stakeholders to understand system functionality, identify testable requirements, and resolve issues.• Develop, execute, and maintain comprehensive test plans, test cases, and test scripts to validate bioinformatics software functionality, performance, and compliance.• Perform manual and automated testing (e.g. functional, integration, regression, system testing) to ensure alignment with software requirements, risk assessments, and quality standards.• Identify and implement improvements to testing processes, methodologies, and tools (e.g. automated test frameworks, quality metrics tracking) to enhance software quality and team productivity.
Regulatory Compliance and Risk Management• Ensure all testing activities comply with applicable IVD and/or LDT regulations (e.g. 21 CFR Part 11, 21 CFR Part 820, CAP/CLIA, NYS DOH, IVDR) and standards (e.g. IEC 62304, ISO 13485, ISO 14971).• Maintain awareness of data privacy and security frameworks (e.g. HIPAA, SOC II, GDPR) to align with compliance needs.• Develop and maintain traceability matrices linking test cases to software requirements, risk analyses, and design inputs/outputs.• Contribute to software risk assessments and hazard analyses (e.g. FMEA) to identify and mitigate potential risks to patient safety.• Support the preparation of documentation for design reviews, regulatory submissions, and audits.
What’s Fun About the Job?Karius is operating at the edge of what is now known to be possible in infectious disease diagnostics. With that, comes a wave of new and incredible challenges and opportunities. To deliver on that value, you will be tapping into some of the most advanced technologies, architecting and innovating where the current solutions simply don't suffice. You will get to see how much your work really matters.
Travel: Travel required up to 10% to headquarters for team meetings.
Physical RequirementsSubject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office environment.
Position Requirements• Bachelor's degree (or M.S. degree) in Computer Science, Software Engineering, Electrical Engineering, Bioengineering, Bioinformatics, or related technical fields involving algorithms or coding (e.g., Physics or Mathematics).• 5+ years of experience in software quality engineering, with
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