Senior Software Quality Engineer

About Karius

Karius 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 Summary

We 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:  Senior Manager, Analytical Systems and Data Insights

Location: Redwood City, CA (Hybrid) or Remotely (US only)

Primary Responsibilities

Software 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 Requirements

Subject 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 3+ years in regulated environments (e.g. medical device software).

• Experience with testing and validating bioinformatics pipelines or data-driven software (especially for clinical metagenomics applications) deployed on cloud-based platforms (e.g. AWS) is highly desirable.

• Experience writing clear, concise, and comprehensive test plans and test cases for software verification and validation.

• Experience with programming/scripting languages (primarily Python) and automated testing tools/frameworks (e.g. Postman, Selenium, Playwright, Pytest).

• Experience with the software development lifecycle, requirements management, and traceability software (e.g. JAMA), and software project management tools (e.g. JIRA).

• Experience with version control systems (e.g. Git, Github) and CI/CD processes.

• Familiarity with bioinformatics tools and genomic data formats is a strong plus.

• Strong understanding of federal regulations pertaining to IVD and/or LDT development (e.g. 21 CFR Part 11, 21 CFR Part 820, CAP/CLIA, NYS DOH) and related standards (e.g. IEC 62304, ISO 13485, ISO 14971).

• Understanding of international medical device regulations (e.g. IVDR) is a plus.

Personal Qualifications

• A proactive and self-motivated individual who thrives in a fast-paced environment.

• Strong organizational and time management abilities.

• Excellent communication and collaboration skills.

• Attention to detail and commitment to delivering high-quality solutions.

• A role model for Karius culture and values, with a commitment to integrity, quality, and excellence.

Disclaimer

The above job description is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. Responsibilities and duties may change or be adjusted to meet the needs of the company, and additional duties may be assigned as necessary. The job description is subject to change at any time at the discretion of Karius.

Equal Opportunity Employer

At Karius, we value a diverse and inclusive workplace and provide equal employment opportunities for all applicants and employees, and are committed to honor and invest in the full diversity of people, in our hiring, recruiting, and development of employees across the Company.  All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual’s race, color, sex, gender identity, and gender expression (including transgender individuals who are transitioning, have transitioned, or are perceived to be transitioning to the gender with which they identify), religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application due to a disability, please contact us at recruiting@kariusdx.com and we will accommodate qualified individuals with disabilities.