2 years ago
Boston, MA, USA +2 moreSenior
Base Salary
$123k - $189k/yr
Responsibilities
- Participate in implementing the Software Quality Management System in conformance with US FDA Quality System Regulations, ISO 13485 Design Controls, SDLC processes, and industry best practices.
- Support software development teams in creating Design History Files, including development plans, verification and validation plans, requirements, architecture and design documents, reviews, risk management files, 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.
- Provide training and education on the software QMS and SDLC framework and support CAPA, complaints, audits, and overall QMS activities.
Requirements
- BA/BS degree in Computer Science, Software Engineering, Informatics, Biomedical, or a related technical field, or equivalent practical experience.
- Five years of experience in software design assurance within the FDA QSR/ISO 13485 medical device industry, primarily working on Software as a Medical Device.
- Experience applying IEC 62304, AAMI TIR45, ISO 14971, and IEC 62366.
- Experience in project management, training, and collaboration with software development teams.
- Preferred experience with digital health, Health IT, or mobile medical applications.
- Preferred experience working on AI/ML-enabled medical device products.
- Preferred experience implementing and improving Software QMS processes using SDLC best practices and agile, Scrum, or iterative methodology.
- Preferred knowledge of regulatory requirements for wellness, low-risk, and high-risk software applications and scalable SDLC and QMS practices.
- Strong organizational, interpersonal, verbal, and written communication skills, with the ability to deliver quality outputs under minimal supervision.
Benefits
- Flexibility, resources, and competitive benefits supporting whole-person well-being.
- Bonus and equity are included in addition to base salary.
Categories
About Verily
Verily Health is a data platform and technology company purpose-built to power AI-enabled precision health. We combine deep clinical, regulatory, and technological expertise to provide our customers with patient-centric solutions that make healthcare more personal and precise. Verily solutions are designed to make healthcare data AI-ready and fit for purpose across care, research, and public health. For more information about Verily please visit: verily.com. Verily is hiring! Check out what's available globally at verily.com/careers.