• Actively participate as a core team member of the R&D Quality Assurance Engineering team. • Provide guidance on IEC 62304, 21 CFR 820, ISO 14971 and other relevant regulations worldwide to cross-functional teams. • Lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams. • Provide technical guidance with respect to equipment, software, product, process requirements and driving risk management deliverables like SHA, design and process FMEA. • Provide guidance to Software Design and Test Teams for System validations, Software design verification and traceability, Software configuration management, tool validations and software integrations. • Support post market activities related to Software anomalies, risk assessments and CAPA activities (if applicable). • Responsible for reviewing, authoring, revising, and approving appropriate technical documentation including design history file, standard operating procedures, protocols, reports, and software design control deliverables. • Assess impact of change control to ensure no adverse impact to product performance and a state of compliance is maintained. • Effectively communicate with broad Dexcom team and upper-level management on plans, status of tasks, project progress and challenges. • Assume and perform other duties as assigned.