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Guardant Health focused on rare-cell diagnostics
Engineering, Full Time       Posted: Thursday, January 10, 2019
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  Company Description


Guardant Health develops breakthrough diagnostic technologies to improve cancer management. With Guardant360, we offer real-time, biopsy-free tumor sequencing that tracks tumor genomics in real-time & identifies associated treatment options. The recent introduction of groundbreaking analytical tools, including our Tumor Response Map & a mobile-enabled physician portal, further advance Guardant Health's momentum.

Guardant Health has raised almost $200M from OrbiMed, Sequoia Capital, Khosla Ventures, Lightspeed Venture Partners, & Formation8, & is led by a seasoned management team of thought leaders & successful serial entrepreneurs in next generation sequencing & rare cell diagnostics. They are advised by an oncologist-led medical steering committee from leading cancer centers.

Job Description

Position Summary:

This role is in the bioinformatics team focusing on our Lunar project - you will be working on the software that is used in the clinical laboratory to process patient samples & analyze their genomic profiles, finding the right treatment options for cancer patients based on a simple blood draw. You will participate in a small team following agile methodology. Your role would be to ensure that the software verification & validation is complete, the product is safe & of high quality, & meets all regulatory requirements.

Essential Duties & Responsibilities:

  • Work with development engineers, clinical teams, & product managers to resolve issues related to usability, requirements, software, scope, schedule, & resources.

  • Lead & participate in requirements analysis, use case development & risk / hazard analysis (FMEA)

  • Lead the verification & validation strategy for system development projects in an FDA regulated environment that meet internal quality requirements & regulatory standards (ISO 13485, FDA 21 CFR 11, FDA 21 CFR 820, ISO 14971, IEC 62304)

  • Responsible for creating clear & concise test plans & protocols, executing protocols, & generating test reports & trace matrices for multiple software components as part of a larger system.

  • Understand & embrace Design Controls in software development.

  • Be the quality advocate & enforce standards within the software development life cycle

  • B.S. in Engineering or Science discipline

  • 3-5 years experience in the medical device industry

  • Excellent verbal & written communications.

  • Must be able to summary technical information to a variety of functions.

  • Demonstrable ability to perform the Essential Duties & Responsibilities of this position

  • Effective communicator with written & verbal fluency in English

  • Detail oriented with an initiative to drive tasks to completion

  • Ability to work well in a rapid-pace startup environment

  • Ability to work well in a group & independently with minimal supervision

Additional Information

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

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