Senior Software Quality Engineer

Summary

Join Karius, a life science startup, as a Senior Software Quality Engineer. You will ensure the quality, performance, and compliance of our AI-driven data analytics software. Collaborate with engineers, product managers, and stakeholders to develop and execute comprehensive test plans. Your work will directly impact the accuracy and reliability of our system, providing actionable insights for patient treatment. This hybrid or remote (US only) role offers the opportunity to contribute to life-changing work in infectious disease diagnostics, utilizing advanced technologies and making a real difference in patient care. The position reports to the Senior Manager, Analytical Systems and Data Insights, located in Redwood City, CA.

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 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
• 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)

Responsibilities

• 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
• 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

Preferred Qualifications

• Experience with testing and validating bioinformatics pipelines or data-driven software (especially for clinical metagenomics applications) deployed on cloud-based platforms (e.g., AWS)
• Familiarity with bioinformatics tools and genomic data formats
• Understanding of international medical device regulations (e.g., IVDR)
• 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

Benefits

• Hybrid or Remote (US only) work option
• Travel required up to 10% to headquarters for team meetings