Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening.

Guardant Health seeks an energetic and passionate Senior Software Quality Engineer to join its Software Engineering team. This team is responsible for delivering the product functionality needed to support the laboratory workflow for several of its market leading cancer diagnostic tests as well as integration with various oncology systems.

An ideal candidate would have experience working in a regulated environment with a thorough knowledge of quality engineering best practices and technical expertise to deliver software products that meet business needs in an efficient and fast-paced environment. This role requires someone adept at understanding system architecture, design, and implementation to succinctly develop tailored test strategies and deliver quality software products meeting regulatory standards. The candidate should be apt to work on parallel projects with overlapping schedules, quickly learn new technologies, and demonstrate teamwork and technical leadership.

Essential Duties and Responsibilities:

• Design and execute test coverage for various functional and integration aspects of the Enterprise Lab Information Management System (LabVantage).
• Apply appropriate test methodologies, including but not limited to writing test plans and test cases and executing test scripts within the sprint schedule.
• Create automated test cases and execute them to support scheduled releases.
• Troubleshoot issues identified during testing and report defects; able to distinguish between user error and application anomalies.
• Perform System Integration and performance testing before product releases.
• Provide clear and concise feedback on defects, usability, and other test findings/results.
• Contribute to the continuous improvement of QA processes and methodologies.
• Collaborate with cross-functional teams to ensure timely and robust testing execution as part of a regular release schedule.
• Provide coaching to other team members for designing test strategies and test cases.
• Execute complex testing scenarios, perform in-depth statistical analysis, and interpret results independently.
• Apply QE standards, best practices, and principles to develop quality plans that deliver optimal outcomes across multiple products.
• Deliver test documentation to support software development for medical devices in compliance with FDA, IVDR, CE mark, IEC 62304, PMDA, and ISO 13485 standards.
• Stay updated on industry best practices and emerging technologies relevant to software quality assurance in life sciences.

• B.S. or higher degree in Computer Science, Engineering, Bioinformatics, or a related study or equivalent project experience.
• 8+ years of hands-on testing experience in Service Oriented Architecture environment using COTS/SaaS solutions with API led integrations.
• Solid experience in programming languages like Java, Python
• 5+ years of experience in testing integrations in a hybrid environment leveraging XML/JSON/HL7 message formats.
• 5+ years of experience using databases like Postgres, Oracle, MSSQL Server or Mongo DB.
• 5+ years of experience in test preparation activities within an Agile Development Process – Test Design, Test scripting, Test Data creation.
• 5+ years of API test tools like Postman, Fiddler, RestAssured, SOAPUI, JMeter required.
• Develop test automation scripts to support CI/CD pipeline for software delivery.
• Proven ability to adapt to new technologies and design test strategies.
• Extensive experience in good testing practices, QA methodologies, tools, and processes.
• Excellent communication, presentation, and analytical skills, including strong ability to identify and solve ambiguous cross-functional software quality related problems.
• Expertise in measuring and reporting quality-related metrics to identify trends, anomalies and proactively resolve problems.
• Experience in identifying, analyzing, and narrowing down system integration issues and performing root cause analysis.
• Expertise in developing and maintaining SDLC documentation such as Verification Plan, Report, Validation Plan, Risk Assessment, and Traceability Matrix, etc.
• Ability to deliver software releases in frequent cycles using agile methodology.

 Desirable, but not Required:

• 3+ years of performing verification and validation activities in medical device, pharma or healthcare regulated environments.
• Experience working in a regulated environment (CLIA, CAP, HIPAA, SOX, 21 CFR Part 11, ISO 13485, IEC 62304, and other FDA regulations)
• Working experience in MuleSoft platform.

Hybrid Work Model: At Guardant Health, we have defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant, our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.

For positions based in Palo Alto, CA or Redwood City, CA, the base salary range for this full-time position is $111,800 to $150,900 The range does not include benefits, and if applicable, bonus, commission, or equity.

Within the range, individual pay is determined by work location and additional factors, including, but not limited to, job-related skills, experience, and relevant education or training. If you are selected to move forward, the recruiting team will provide details specific to the factors above.

Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to [email protected]

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

All your information will be kept confidential according to EEO guidelines.

To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants.

Please visit our career page at: http://www.guardanthealth.com/jobs/

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