Full Job Description
Bachelor’s 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 medical device industry.
Experience in project management, training, and working with software development teams.
Experience participating in regulatory audits and presenting technical subjects to regulators during pre-market reviews.
Experience with Consumer Products, digital health, Health IT or mobile medical applications.
Experience working with novel technologies in an ambiguous and innovative environment.
Experience with the application of IEC 62304 (Medical Device Software Lifecycle Processes), AAMI TIR45, and IEC 62366 Usability Engineering.
Knowledge of regulatory requirements for wellness, low-risk and high-risk software applications using a scalable approach to the SDLC practices and the QMS.
Ability to implement and improve Software QMS processes using SDLC best practices, tools and agile/scrum/iterative methodology.
Excellent organizational, independent productivity, and verbal and written communication skills.
About the job
Within the Google Health team, we bring together specialists who know what it takes to deploy clinical tools in practice - Engineers, Clinicians, Designers, and more. In this role, you will use your technical skills to build an intuitive and safe mobile experience that improves how healthcare is delivered.
Google Health has made major advances in healthcare research, such as detecting eye disease more quickly and accurately than experts, planning cancer radiotherapy treatment in seconds rather than hours, and working to detect patient deterioration before it happens with electronic records.
Fundamental research is at the core of Google Health - the multidisciplinary team collaborates with partners to publish novel research in renowned scientific journals. They then work to apply this research into the medical field, whether through Streams, our clinical assistant app, or other clinical hardware and products developed in Google. Working alongside colleagues across Google, you’ll help make this vision a reality.
Participate in ongoing implementation of a Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls through the integration of internal and medical device industry best practices.
Support software development teams in the creation of Design History Files (DHFs) including design and development plans, verification and validation plans, software requirements specifications, software architecture and design documents, design and code reviews, Risk Management File (RMF), test protocols and reports and traceability matrices.
Support integration of risk management and usability engineering activities with SDLC processes.
Guide 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.
Google is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also Google's EEO Policy and EEO is the Law. If you have a disability or special need that requires accommodation, please let us know by completing this form.