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Lead Software Quality Engineer

2 months ago

Palo Alto, California, United States Guardant Health Full time
Position Overview:

Guardant Health is in search of a dedicated and enthusiastic Senior Software Quality Engineer to enhance its Software Engineering division. This team plays a crucial role in delivering essential product functionalities that support laboratory workflows for several leading cancer diagnostic tests, alongside integration with various oncology systems.

The ideal candidate will possess experience in a regulated setting, demonstrating a comprehensive understanding of quality engineering best practices and the technical acumen necessary to produce software solutions that effectively meet business requirements in a dynamic environment. This role demands proficiency in grasping system architecture, design, and implementation to develop customized testing strategies and ensure the delivery of high-quality software products that comply with regulatory standards. The candidate should be capable of managing multiple projects with overlapping timelines, rapidly acquiring new technologies, and showcasing both teamwork and technical leadership.

Key Responsibilities:

  • Design and implement test coverage for various functional and integration components of the Enterprise Lab Information Management System (LabVantage).
  • Utilize appropriate testing methodologies, including drafting test plans and cases, and executing test scripts within the sprint timeline.
  • Develop automated test cases and execute them to facilitate scheduled releases.
  • Identify and troubleshoot issues during testing, accurately reporting defects and distinguishing between user errors and application anomalies.
  • Conduct System Integration and performance testing prior to product launches.
  • Provide clear and concise feedback regarding defects, usability, and other testing findings.
  • Contribute to the ongoing enhancement of QA processes and methodologies.
  • Collaborate with cross-functional teams to ensure timely and effective testing execution as part of a regular release schedule.
  • Mentor team members in designing test strategies and test cases.
  • Execute complex testing scenarios, perform detailed statistical analyses, and independently interpret results.
  • Apply quality engineering standards, best practices, and principles to formulate quality plans that yield optimal outcomes across multiple products.
  • Deliver comprehensive test documentation to support software development for medical devices in accordance with FDA, IVDR, CE mark, IEC 62304, PMDA, and ISO 13485 standards.
  • Stay informed about industry best practices and emerging technologies pertinent to software quality assurance in life sciences.

Qualifications:

  • B.S. or higher degree in Computer Science, Engineering, Bioinformatics, or a related field, or equivalent project experience.
  • 8+ years of hands-on testing experience in a Service-Oriented Architecture environment utilizing COTS/SaaS solutions with API-led integrations.
  • Strong proficiency in programming languages such as Java and Python.
  • 5+ years of experience testing integrations in a hybrid environment using XML/JSON/HL7 message formats.
  • 5+ years of experience with databases including Postgres, Oracle, MSSQL Server, or MongoDB.
  • 5+ years of experience in test preparation activities within an Agile Development Process – including Test Design, Test Scripting, and Test Data creation.
  • 5+ years of experience with API testing tools such as Postman, Fiddler, RestAssured, SOAPUI, and JMeter.
  • Develop test automation scripts to support CI/CD pipelines for software delivery.
  • Demonstrated ability to adapt to new technologies and design effective test strategies.
  • Extensive experience in quality testing practices, QA methodologies, tools, and processes.
  • Excellent communication, presentation, and analytical skills, with a strong ability to identify and resolve complex software quality-related issues.
  • Expertise in measuring and reporting quality-related metrics to identify trends and proactively address problems.
  • Experience in identifying, analyzing, and resolving system integration issues through root cause analysis.
  • Expertise in developing and maintaining SDLC documentation such as Verification Plans, Validation Plans, Risk Assessments, and Traceability Matrices.
  • Ability to deliver software releases in frequent cycles using agile methodologies.

Desirable Qualifications:

  • 3+ years of experience in verification and validation activities within regulated environments such as medical devices, pharmaceuticals, or healthcare.
  • Experience working in a regulated environment (CLIA, CAP, HIPAA, SOX, 21 CFR Part 11, ISO 13485, IEC 62304, and other FDA regulations).
  • Familiarity with the MuleSoft platform.

Work Environment:

Guardant Health has established a hybrid work model, defining specific days for in-person collaboration and work-from-home arrangements for focused individual tasks. Employees residing within proximity to a Guardant facility will be required to be onsite on designated days. This model promotes a balance between collaborative work and individual productivity, fostering an environment conducive to innovation.

Equal Opportunity Employment:

Guardant Health is committed to providing equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status. We ensure that all information will be kept confidential according to EEO guidelines.