FDA 21 CFR Part 820, IEC 62304, & ISO 13485) You will be responsible for guiding teams in execution of Software Life Cycle and design control activities You will lead risk management activities to positively impact the safety and efficacy of products You will facilitate teams in identifying, documenting, assessing, correcting, and preventing quality issues using risk analysis and root cause analysis tools, starting with initial product concept to design transfer and post-market surveillance You will be responsible for identifying areas of process improvements and driving process improvements activities; including designing, updating, and applying company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations You will participate in Cyber security risk assessments You will work closely with mobile app teams as a technical quality representative As a member of the Design Team, your activities may include assisting with defining design inputs, designing components and processes, and verifying that design outputs satisfy design inputs, all while guiding R&D teams through a risk-based approach to design You will participate in health hazard assessments for product field issues What makes you successful: You’ll need a minimum of a Bachelor’s degree with 6+ years of related experience (advanced degree and 4+ years related experience can substitute); medical device or other regulated industry preferred Your Medical Device experience in compliance with the requirements of FDA 21 CFR Part 820, IEC 62304, ISO 13485 Your extensive knowledge and experience with SDLC processes along with software development and test methodologies such as Agile Software Development, Waterfall Model, etc. Your Software Quality and/or Engineering experience in Requirements Analysis, Design/Development, Product Integration and Test Your ability to interpret software design and code to verify implementation of requirements Your ability to work in a hands-on, fast-paced environment, understand complex tasks and goals, and drive projects to completion with limited supervision Your proficiency at written and verbal communication skills, including experience with presenting to all levels of management An understanding of mobile device operating system software/hardware (applications, internet connection, Bluetooth communication) ASQ Certified Software Quality Engineer What you’ll get: A front row seat to life changing CGM technology.