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Redwood City, California - USD Full Time Posted: Wednesday, 16 May 2018
 
 
This role is in the bioinformatics team you will be working on the software that is used in the clinical laboratory to process patient samples and 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 and validation is complete, the product is safe and of high quality, and meets all regulatory requirements.
Essential Duties and Responsibilities:
Work with development engineers, clinical teams, and product managers to resolve issues related to usability, requirements, software, scope, schedule, and resources.
Lead and participate in requirements analysis, use case development and risk/hazard analysis (FMEA)
Lead the verification and validation strategy for system development projects in an FDA regulated environment that meet internal quality requirements and regulatory standards (ISO 13485, FDA 21 CFR 11, FDA 21 CFR 820, ISO 14971, IEC 62304)
Responsible for creating clear and concise test plans and protocols, executing protocols, and generating test reports and trace matrices for multiple software components as part of a larger system.
Understand and embrace Design Controls in software development.
Be the quality advocate and enforce standards within the software development life cycle
Qualifications:
3-5 years experience in the medical device industry
Excellent verbal and written communications.
Must be able to summary technical information to a variety of functions.
Demonstrable ability to perform the Essential Duties and Responsibilities of this position
Effective communicator with written and 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 and independently with minimal supervision
Education
B.S. in Engineering or Science discipline


Redwood City, California, United States of America
IT
USD
Guardant Health
Guardant Health
JS2365_A13A05E0DDCEFBA077015881EF9E3BE2/418218166
5/16/2018 11:58:25 AM

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