Software Quality Engineer, Health

Minimum Qualifications: Bachelor's degree in Engineering 3 years of experience in design quality engineering in the medical device industry Experience and understanding of product development processes and design controls in medical devices Experience with ISO 13485, QSR 820, and ISO 14971 standards Preferred... Qualifications: Master's degree in Engineering Experience working with technologies in an ambiguous and innovative environment Experience with the application of IEC 62304, TIR 45, and IEC 62366 Experience in Software as Medical Devices (SaMD) Experience with the application of GAMP5 methodology for software validation About the job You will be studying the use of artificial intelligence to assist in diagnosing cancer, predicting patient outcomes, preventing blindness, and much more. You'll be exploring ways to improve patient care, including tools that are already being used by clinicians. You'll partner with doctors, nurses, and other healthcare professionals to help improve the care patients receive. In a highly-regulated, safety-conscious environment, you will work hand-in-hand with Product and Design as part of the Quality, Regulatory, and Safety team to build high-quality applications that create intuitive and safe experiences with real impact in today's healthcare. As a Software Quality Engineer, you will be responsible for implementing robust and efficient design control and risk management processes, and maintaining compliance throughout the product life cycle. 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 through clinical hardware and products developed in Google. Working alongside colleagues across Google, you'll help make this vision a reality. Responsibilities Support development teams in the creation of Design History Files (DHFs) including design and development plans, verification and validation plans, 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 Software Development Life Cycle (SDLC) processes. Support development teams in the creation and execution of Computerized Software Validation. Guide development teams in applying design controls and risk management activities. Foster organizational compliance to the quality system including ongoing training and education on the Quality Management System (QMS) and Software Development Life Cycle (SDLC) framework. Salary Range: $80K -- $100K Minimum Qualification Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications