fmea jobs in San Diego

Sr. Systems Engineer at Globus Medical responsible for complex medical device system development, leading cross-functional coordination across software, hardware, clinical, regulatory, and manufacturing teams.…See more The role requires decomposing intricate systems, troubleshooting subsystem interactions, conducting risk analysis per ISO 14971, and driving continuous improvement through design of experiments and root cause analysis. Requires 5+ years in complex system development (medical devices, robotics, or similar) with strong systems engineering principles, FDA-regulated product development experience, and ability to translate technical concepts across multidisciplinary disciplines.

As a Senior Software Technical Product Manager at Illumina, you will drive software design decisions for sequencing instrument platforms by translating user needs into product concepts and requirements. You'll collaborate with cross-functional teams (firmware, hardware, test) on release planning, backlog prioritization, and requirements management while creating wireframes, workflow diagrams, and formal specification documents.…See more The role requires deep involvement in use case development, competitive analysis, risk identification (FMEA, cybersecurity), and Voice of Customer advocacy across clinical, research, and applied segments. You'll manage scope and change control for multiple concurrent instrument development efforts while ensuring compliance with medical device regulations (IEC 62304, FDA guidance) and best practices in formalized requirements engineering.

Staff QA Engineer at Dexcom leading manufacturing quality and regulatory compliance for continuous glucose monitoring devices. Responsibilities include directing Design Control and design transfer strategy, managing process validation and commercialization, leading cross-functional teams on complex technical and compliance matters, and providing expert guidance on Quality Management System governance (FMEA, CAPA, process controls).…See more Requires deep hands-on experience with FDA 21 CFR 820, ISO 13485, and related QMS requirements, plus ability to mentor teams and represent the organization during audits and regulatory inspections.

As a Systems Engineer, you will troubleshoot complex mechanical, electrical, and software issues in advanced 3D printing (ECAM) systems, identify root causes, and develop solutions to improve printer fleet performance. You'll analyze manufacturing and quality data to drive continuous improvement, apply structured problem-solving methodologies (8D, 5 Whys, Fishbone), and support corrective and preventive actions (CAPA).…See more You'll partner across mechanical, electrical, and software engineering teams to ensure system integration, develop technical documentation and SOPs, and execute functional test plans. The role requires hands-on troubleshooting of electromechanical systems, knowledge of quality tools and methodologies, and CAD expertise.