Company Description
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.
Job Description
Guardant Health is looking for 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 thorough knowledge of Quality Engineering best practices and technical expertise to deliver software products meeting the business needs in an efficient and fast paced environment. This role requires someone who is adept at understanding system architecture, design, implementation to succinctly develop tailored test strategy and deliver quality software products meeting regulatory standards. The candidate should have the aptitude to work on parallel projects with overlapping schedules, quickly learn new technologies, 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, test cases, and execution of 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 prior to 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 execution of testing 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.
Qualifications
Qualifications:
- 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.
Additional Information
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/
