dfmea 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.

Sr. Director of Software Quality will build and lead Illumina's standalone Software Quality organization, establishing governance frameworks aligned with IEC 62304, ISO 13485, ISO 14971, and emerging AI Act requirements.…See more The role owns the Software Quality Management System across all software products, software-driven IVDs, and AI/ML-enabled diagnostics, embedding quality checkpoints throughout the product development lifecycle and post-market surveillance. Responsibilities include recruiting and developing a high-performing team, defining verification and validation standards, managing regulatory compliance for FDA, EU MDR/IVDR, and other global bodies, and serving as the subject-matter expert in regulatory inspections. The candidate must have deep hands-on expertise in IEC 62304, SaMD classification frameworks, cybersecurity in QMS (IEC 81001-5-1), and demonstrated experience building and leading software quality functions in regulated medical device environments.

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.

Engineering Manager leading a mechanical systems team at an aerospace company designing and delivering actuated mechanisms for air vehicles. Responsible for end-to-end mechanism design (doors, landing gear, flight control actuation, propulsion systems), setting quality standards, enabling team autonomy, and fostering cross-functional collaboration across systems, structures, aero, propulsion, GNC, avionics, manufacturing, and test.…See more Will mentor and develop engineers, manage workload across multiple builds and test campaigns, and ensure transparent communication of risk and schedule impacts. Requires 10+ years in aerospace mechanisms and actuated system design with 2+ years in a team leadership role.

Lead hardware and firmware integration for Tesla's cell manufacturing equipment, performing system validation from PCBA design through production deployment. Debug complex HW/SW interactions across power electronics and battery systems, create automated test infrastructure, and drive root-cause analysis on field escalations.…See more Partner cross-functionally with electrical, manufacturing, and process engineering teams to ensure functional, performance, safety, and reliability requirements are met across Formation and Cell Qualification equipment.

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.