As a Senior Software QA Engineer at Dexcom, you will investigate postmarket software and device issues in collaboration with Regulatory, Quality, R&D, and Clinical teams, applying structured problem-solving and statistical analysis to identify root causes and drive corrective actions. You will develop and improve complaint investigation processes aligned with software risk management activities (hazard analysis, DFMEA, PFMEA, risk assessments) and ensure compliance with FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, and other medical device regulations.… You will analyze product performance anomalies, cybersecurity vulnerabilities, and postmarket trends to conduct software-focused risk assessments, then communicate findings and recommendations to technical and non-technical stakeholders to inform decision-making. You will translate postmarket insights into actionable product improvements that enhance safety, reliability, user experience, and regulatory compliance.
eu-mdr jobs in San Diego
Sr Product Surveillance Engineer responsible for investigating postmarket software and device issues, driving complaint investigation processes, and ensuring regulatory compliance for medical devices. The role requires deep understanding of Dexcom's software architecture to evaluate product performance, apply structured problem-solving and statistical analysis to root-cause investigations, and communicate findings to technical and non-technical stakeholders.… You will support quality system activities (CAPA, HHEs), conduct software risk assessments, and partner with product and quality teams to translate postmarket insights into product improvements. Success requires demonstrated knowledge of FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, and medical device quality systems.
Lead complex medical device development programs for Dexcom's Stelo wearable glucose biosensor platform, driving cross-functional teams through research, verification, validation, and commercialization. Direct R&D, commercial, operations, quality, clinical, regulatory, and legal stakeholders; manage product roadmaps, timelines, and executive governance; resolve technical and business tradeoffs while mentoring team members.… Requires proven experience shipping novel wearable or connected medical devices with expertise across mechanical, electrical, systems, and mobile app engineering disciplines, plus familiarity with FDA and EU MDR regulatory pathways.
This Systems Engineer role at a medical device company requires decomposing regulatory and stakeholder requirements into testable system specifications, leading design reviews and verification/validation activities, and supporting risk management under FDA and ISO frameworks. The position demands 2+ years in a regulated medical device environment, with responsibility for traceability documentation, design history files, failure investigation, and CAPA activities.… Key competencies include FDA design controls, ISO 14971 risk management, human factors/usability per FDA guidance, and cross-functional communication of complex system interfaces to diverse audiences.