Lead Software Quality Engineer

1 week 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 various leading cancer diagnostic tests, alongside integration with diverse oncology systems.

The ideal candidate will possess substantial experience in a regulated setting, demonstrating a comprehensive understanding of quality engineering principles and the technical acumen necessary to produce software solutions that align with business objectives in a dynamic environment. This role demands proficiency in system architecture, design, and implementation to effectively craft customized testing strategies and ensure the delivery of high-quality software products that adhere to regulatory requirements. The candidate should be capable of managing multiple projects with overlapping timelines, swiftly assimilating new technologies, and showcasing both teamwork and technical leadership.

Key Responsibilities:

  • Develop 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.
  • Generate automated test cases and execute them to facilitate scheduled releases.
  • Diagnose issues identified during testing and document defects, 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 outcomes.
  • 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 cycle.
  • Mentor other team members in designing test strategies and cases.
  • Execute complex testing scenarios, perform detailed statistical analyses, and independently interpret results.
  • Apply quality engineering standards, best practices, and principles to develop quality plans that yield optimal results across multiple products.
  • Deliver comprehensive test documentation to support software development for medical devices in compliance with relevant regulatory standards.
  • Stay informed about industry best practices and emerging technologies pertinent to software quality assurance in the life sciences sector.

Qualifications:

  • Bachelor's degree or higher in Computer Science, Engineering, Bioinformatics, or a related field, or equivalent project experience.
  • Over 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 like 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.
  • Ability to develop test automation scripts to support CI/CD pipelines for software delivery.
  • Demonstrated adaptability to new technologies and design of test strategies.
  • Extensive experience in effective testing practices, QA methodologies, tools, and processes.
  • Exceptional communication, presentation, and analytical skills, with a strong ability to identify and resolve complex software quality issues.
  • Expertise in measuring and reporting quality-related metrics to identify trends and proactively address issues.
  • Experience in diagnosing, analyzing, and resolving system integration challenges through root cause analysis.
  • Expertise in creating and maintaining SDLC documentation such as Verification Plans, Validation Plans, Risk Assessments, and Traceability Matrices.
  • Proficient in delivering 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 (e.g., CLIA, CAP, HIPAA, SOX, 21 CFR Part 11, ISO 13485, IEC 62304, and other FDA regulations).
  • Familiarity with the MuleSoft platform.

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