Manager, Software Quality Engineering

  • Full-time

Company Description

ABOUT OUR COMPANY

We believe conquering cancer is a big data problem. That’s why we built the world’s leading comprehensive liquid biopsy. This non-invasive tool for accessing and sequencing tumor DNA is used by thousands of oncologists to help tens of thousands of advanced cancer patients. We believe the boom in cancer data acquisition we helped launch will drive important discoveries and new products. We’re working on some exciting ones, including in early detection, where the impact on patients can be profound. We’ve raised more than $500 million from investors including Sequoia Capital, Khosla Ventures, OrbiMed, and SoftBank.

 

Job Description

Manager, Software Quality Engineering – LIMS Platform

Position Summary:

Guardant Health is looking for an energetic and passionate manager to lead its LIMS platform Quality Engineering team. LIMS platform team maintains, supports, and scales the platform, which provides laboratory workflows from order intake to result distribution and invoicing.

An Ideal candidate would have experience in leading software quality team in a regulated environment with thorough knowledge of Quality Engineering best practices and technical expertise to guide the team in delivering software products meeting the business needs in an efficient and fast paced environment. This role requires someone to be self-directed, autonomous, empowered, with coaching and critical thinking ability.

Essential Duties and Responsibilities:

  • Hire, train, coach, mentor and develop high-performing, geographically distributed team of software quality engineers in an Agile SDLC environment.
  • Build and promote quality driven culture in delivering COTS based LIMS Platform, Service oriented architecture and cloud-based API integration platforms.
  • Co-define system integration test strategy with cross functional work streams featuring rich, complex business logic-oriented customer usage patterns.
  • Provide accurate planning, effort and resource estimates, and milestones for testing to ensure successful implementation in a timely fashion.
  • Effectively lead resource allocation based on project priorities and engage in trade-off negotiations to safeguard the team.
  • Identify cross-platform software quality challenges and devise innovative solutions for refinement and improvement of quality deliverables.
  • Establish cross-functional relationships across business and technical leads, architects, and product owners to ensure alignment with business goals and enterprise-level architectural standards.
  • Apply QE standards, best practices, and principles to develop quality plans that deliver optimal outcomes across multiple products.
  • Define and guide automation team in terms of adding value to the process with increased speed of delivery without compromising Quality.
  • Provide technical competency for selection of tools, approaches, and strategies to challenge the status quo and ensure perpetual quality improvement.
  • Collaborate with DevOps team to define environmental needs for functional, integration and pre-production phases leading to successful delivery of monthly and adhoc releases.
  • Deliver test documentation to support software development for medical devices in compliance with FDA, CE mark, IEC 62304, PMDA and ISO 13485 standards.

 

Qualifications

Qualifications:

As a Manager, Software Quality Engineering you are adept at understanding system architecture, design, implementation to succinctly develop tailored test strategy and deliver quality software products meeting regulatory standards. You have the aptitude to work on parallel projects with overlapping schedules, quickly learn new technologies, demonstrate teamwork and technical leadership. You seek feedback and integrate it in a professional manner. In addition, you bring:

  • B.S or higher degree in Computer Science, Engineering, Bioinformatics, or a related study or equivalent project experience.
  • 6+ years of leading software quality engineering team, in a globally distributed environment preferably in healthcare, pharma or regulated environments.
  • 7+ years of hands-on testing experience in Service Oriented Architecture environment using COTS/SaaS solutions with API led integrations.
  • 5+ years of experience in testing integrations in a hybrid environment leveraging HL7/XML/JSON message formats.
  • Designed test automation 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, methodologies, and automated tools.
  • Excellent communication 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, Risk Assessment and Traceability Matrix, etc.
  • Effective communication and presentation skills.
  • Ability to deliver software releases in frequent cycles using agile methodology.
  • Experience working in a regulated environment (CLIA, CAP, HIPAA, SOX, 21 CFR Part 11, ISO 13485, IEC 62304, and other FDA regulations) is desired.
  • Working experience in MuleSoft platform is a plus.

Additional Information

Work Environment:

 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.We would like to talk with you about our exciting projects we currently have ongoing. Please see guardanthealth.com/jobs for more information and to apply.

 

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