Verily Life Sciences is focused on shifting health care from a reactive, undifferentiated approach to a proactive, targeted approach by transforming the detection, prevention, management and even our basic understanding of disease.

As a Principal Software Quality Engineer at Verily, you will work with the software organization to act as a champion of Quality Assurance and Engineering activities throughout software development lifecycle. You hold your work and teams to the highest quality standards and ensure that all corporate business requirements, regulations, and other standards are met as applicable. This is a hands-on role where you will apply intensive, self-directed and diversified knowledge of engineering and quality principles for Verily’s software and platforms.

Responsibilities
Lead the ongoing implementation of Software Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, as well as SDLC processes and tools initiatives, through the integration of internal and external/medical device industry best practices.
Support software development teams in the creation of Design History Files (DHFs) including software development plans, software verification and validation plans, software requirements specifications, software architecture and design documents, design and code reviews, software Risk Management File (RMF), test protocols and reports, traceability matrices.
Integrate of ISO 14971 risk management and IEC 62366 usability engineering activities with SDLC processes.
Mentor and guide software development teams in design controls and lead risk management activities.
Foster organizational compliance to the quality system including ongoing training and education on software QMS and SDLC framework. Provide CAPA, complaints, audit and overall QMS support in regards to software.

Minimum qualifications
Bachelor’s degree in Computer Science, Software Engineering, Informatics, Biomedical, related technical field or equivalent practical experience.
8 years of experience in software design assurance in the FDA QSR/ISO 13485 medical device industry.
Experience with the application of IEC 62304 (Medical Device Software Lifecycle Processes), AAMI TIR45, ISO 14971 (Risk management) and IEC 62366 Usability Engineering.
Project management experience. Experience leading, mentoring, training, and working collaboratively with software development teams.

Preferred qualifications
Experience with digital health, Health IT or mobile medical applications.
Experience working with novel technologies in a lean, fast-paced and highly innovative environment.
Working knowledge of the application of regulatory requirements for wellness, low-risk and high-risk software applications using a scalable approach to the SDLC practices and the QMS.
Track record of implementing and significantly improving Software QMS processes using SDLC best practices, tools and agile/scrum/iterative methodology.
Self-motivated and proactive team member; able to deliver quality outputs under minimal supervision.
Organizational, interpersonal and verbal and written communication skills.

Area
The Verily Life Sciences team is focused on helping to move healthcare from reactive to proactive. Combining expertise from the fields of biology, chemistry, physics, medicine, electrical engineering, computer science, we’re developing new technology tools for physicians that can integrate easily into daily life and help transform the detection, prevention, and management of disease. Current projects in development include a smart contact lens with miniaturized glucose sensor; a nanodiagnostics platform to help with early detection of disease; and Liftware utensils for people with tremor. For more information, please see our website.

Job details
Team or role:Software Engineering
Job type:Full-time
Last updated: Oct 25, 2016
Job location(s):Mountain View, CA, USA