pfmea jobs in San Diego

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.…See more 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.

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.…See more 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.

Staff Reliability Engineer at Qualcomm responsible for developing and executing reliability engineering strategies, performing failure analysis, and applying statistical reliability modeling to influence product and technology decisions. Requires 4+ years of reliability engineering experience (or equivalent with advanced degree) and 1+ year in a technical leadership role.…See more The role demands expertise in Design-for-Reliability (DfR), reliability physics, failure mechanisms, and statistical analysis methodologies, with experience in semiconductor, packaging, or electronic system technologies highly valued.

Senior Software QA Engineer supporting Dexcom's Postmarket Investigations team to assess real-world product performance, investigate software and device issues, and drive continuous improvement. You will collaborate across R&D, Quality, Regulatory Affairs, and Clinical teams to conduct root-cause analyses, perform risk assessments (including hazard analysis, DFMEA, PFMEA), and translate postmarket insights into product enhancements.…See more The role requires deep technical understanding of software architecture, structured problem-solving, statistical analysis, and the ability to communicate findings to both technical and non-technical stakeholders while ensuring regulatory compliance and patient safety.