Senior Software Quality Engineer

Who We Are

Verily is a subsidiary of Alphabet that is using a data-driven approach to change the way people manage their health and the way healthcare is delivered. Launched from Google X in 2015, our purpose is to bring the promise of precision health to everyone, every day. We are focused on generating and activating data from a variety of sources, including clinical, social, behavioral and the real world, to arrive at the best solutions for a person based on a comprehensive view of the evidence. Our unique expertise and capabilities in technology, data science and healthcare enable the entire healthcare ecosystem to drive better health outcomes.

Description

As a Senior 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

• Participate in 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 tool 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 and traceability matrices.
• Support integration of ISO 14971 risk management and IEC 62366 usability engineering activities with SDLC processes.
• Guide software development teams in design controls and 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.
  
  

Qualifications

Minimum Qualifications

• BA/BS degree in Computer Science, Software Engineering, Informatics, Biomedical, related technical field or equivalent practical experience.
• 5 years of experience in software design assurance in the FDA QSR/ISO 13485 medical device industry, primarily working on Software as Medical Device (SaMD).
• Experience with the application of IEC 62304 (Medical Device Software Lifecycle Processes), AAMI TIR45, ISO 14971 (Risk management) and IEC 62366 Usability Engineering.
• Experience in project management, training, and working collaboratively with software development teams.
  
  

Preferred Qualifications

• Experience with digital health, Health IT or mobile medical applications.
• Previous experience working with novel technologies in a lean, fast-paced and highly innovative environment, or working on AI/ML- enabled medical device products.
• 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.
• Demonstrated ability to implement and improve Software QMS processes using SDLC best practices, tools and agile/scrum/iterative methodology. Excellent organizational, interpersonal and verbal and written communication skills, with the ability to deliver quality outputs under minimal supervision.
  
  

Qualified applicants must not require employer sponsored work authorization now or in the future for employment in the United States.

The US base salary range for this full-time position is $123,000 - $189,000 bonus equity benefits. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus or benefits.