Senior Software Quality Engineer

$123,000 - $189,000/Yr

Verily - Boston, MA

Full-time - Senior

Boston, MA

Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services

About the position

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 the 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.

Requirements

• 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.

Nice-to-haves

• 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.

Benefits

• Bonus
• Equity
• Health benefits