• Actively participates as a core team member of the R&D Quality Assurance Engineering team. • Strong understanding of, and ability to provide guidance on IEC 62304, 21 CFR 820, and other relevant regulations worldwide. • Lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams, including: Drive Pre-market risk management deliverables like SHA, design FMEA and support Cyber security risk management. • Provide guidance to Software Design and test teams, support Software configuration management, tool validations and software integrations. • Reviews and approves all software design control deliverables. • Support post market activities related to Software anomalies, risk assessments and CAPA activities (if applicable). • Lead and support R&D SW Design Assurance efforts including continuous improvement opportunities for products and processes. • Responsible for reviewing, authoring, and revising appropriate technical documentation including design history files, standard operating procedures, protocols, reports, etc. • Assesses the impact of change control to ensure no adverse impact on product performance and a state of compliance is maintained. • Effectively communicates with the broad Dexcom team and upper-level management on plans, status of tasks, project progress and challenges. • Assumes and performs other duties as assigned.