Company Description|Job 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.
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
All your information will be kept confidential according to EEO guidelines.