fmea jobs in San Diego

Sr QA Engineer leading complex quality investigations, root cause analysis, CAPAs, and NCMRs at a regulated medical device company (Dexcom). Drives Quality Management System excellence through continuous improvement methodologies (Six Sigma, Lean, process capability analysis), owns validation and qualification strategies for equipment/processes/software, and guides design transfer and commercialization from development to high-volume manufacturing.…See more Requires advanced quality engineering knowledge, hands-on technical aptitude, proficiency with data analysis tools (JMP, Excel), and cross-functional leadership across R&D, Regulatory, Manufacturing, and Engineering teams.

Senior Systems Engineer responsible for defining and maintaining system-level architectures for complex medical devices, including interface control documentation across fluidic, mechanical, electronics, software, and human factors subsystems. The role involves modeling system behavior using functional modeling techniques (SysML, functional block diagrams, state machines), conducting trade studies, and validating architectural assumptions through testing and characterization.…See more Requires partnering with cross-functional engineering teams to ensure subsystem alignment, supporting design controls per 21 CFR 820.30 and ISO 13485, and mentoring engineers on systems thinking and interface definition. This is a hands-on role grounded in bench-top testing, data analysis, and evidence-based architectural decisions rather than paper-only work.

Senior System Engineer responsible for leading systems engineering activities across complex hardware, software, and integrated systems. Plans and executes risk assessments, hazard analyses, design reviews, system integration, and verification/validation strategies while serving as a technical leader on project core teams.…See more Mentors junior engineers, drives continuous improvement initiatives using Design for Six Sigma (DFSS) methodologies, and facilitates cross-functional collaboration across Reliability, Software, Electrical, Mechanical, Quality, Regulatory, Manufacturing, Clinical, and Operations teams. Requires 3–5+ years of engineering experience, strong systems thinking, requirements management expertise, and demonstrated leadership in complex product development.

This role supports the full product lifecycle for complex integrated systems, focusing on requirements management, system integration, verification & validation, and risk management. The Systems Engineer will conduct FMEA and hazard analysis, collaborate across software, electrical, mechanical, quality, and regulatory teams, and drive activities from concept through launch.…See more The position requires 3+ years of systems engineering experience, a bachelor's degree in engineering, and expertise in requirements traceability and risk assessment.

Staff QA Engineer role at Dexcom leading quality engineering for high-volume manufacturing automation, design control, and process validation. Responsibilities include interpreting FDA 21 CFR 820 and ISO 13485 requirements, architecting validation strategies, driving design transfer for commercial deployment, leading complex investigations and CAPA initiatives, and mentoring cross-functional teams.…See more Requires deep expertise in root cause analysis, Six Sigma, process validation, statistical analysis, and data-driven decision-making across global sites.

Staff-level technical leader for Intuit's Traffic platform, owning the API Gateway, Service Mesh, and MCP Gateway that handles all North-South and East-West traffic across Intuit's ecosystem. Responsible for architecture direction, design of the MCP Gateway for AI agent authentication and routing, driving AI-agent-enabled traffic operations (troubleshooting, config analysis, onboarding), and leading major migrations with attention to resiliency and blast-radius containment.…See more Must operate fluently in Envoy/Istio internals while contributing to multi-quarter roadmap strategy, mentoring staff engineers, and serving as technical escalation for P1/P2 incidents affecting shared infrastructure.

Staff QA Engineer at Dexcom leading manufacturing quality engineering and design control for high-volume medical device automation. The role requires deep expertise in FDA 21 CFR 820 and ISO 13485 compliance, design transfer strategy, process validation, and CAPA/MRB leadership across global manufacturing sites.…See more You will mentor cross-functional teams, drive systemic quality improvements, and represent the organization during regulatory inspections, with strong emphasis on data-driven decision-making and risk-based design methodologies.

Staff-level technical leader for Intuit's Traffic platform (API Gateway and Service Mesh), responsible for architecture and engineering direction across mission-critical, company-wide infrastructure. Primary focus areas include designing and hardening the MCP Gateway for secure AI-agent access and leading AI-agent-driven traffic operations (automated troubleshooting, config analysis, service onboarding).…See more Requires deep expertise in Envoy/Istio internals, distributed systems design, Go/Java, and authentication/authorization systems; will own major migrations end-to-end, drive incident response on P1 infrastructure issues, and mentor senior engineers.

Staff Systems Engineer leading technical execution of next-generation autonomous aircraft (UAS) system architecture, including avionics, autonomy, propulsion, sensors, and mission-critical systems integration. Responsibilities include defining system requirements and behavior through model-based systems engineering (MBSE), conducting safety analyses (FHA, FMEA, FTA), trade studies, and ensuring compliance with military and aviation standards.…See more Requires 8+ years in aerospace/defense systems engineering, deep expertise in autonomy-driven flight systems, proficiency in MBSE tools (SysML, DOORS, CAMEO), and experience with Group 4/5 UAS or military aircraft platforms, including flight testing and DoD acquisition processes.

As a Senior Systems Engineer, you will lead the technical design and integration of autonomous aircraft systems for defense applications. You will own system architecture, avionics and autonomy integration, requirements definition and traceability, and cross-functional collaboration from initial design through flight testing and operational deployment.…See more The role demands deep expertise in aerospace systems engineering, model-based systems engineering (MBSE), DoD standards and certification, and autonomous flight systems operating in contested environments.

Support system-level verification planning, coordination, and execution for medical device product development and sustaining engineering projects. Translate customer needs into testable requirements, participate in risk assessments and design reviews, and collaborate across engineering disciplines to resolve technical issues.…See more Apply Design for Six Sigma (DFSS) principles and quality engineering practices throughout the product lifecycle. Requires a bachelor's degree in engineering or related field and 1–2+ years of product testing, design verification, systems engineering, or quality engineering experience.

Systems Engineer II supporting system-level verification planning, execution, and documentation for medical device product development and sustaining engineering projects. The role requires translating customer needs into testable requirements, developing verification protocols and traceability documentation, conducting risk assessments and hazard analyses, and collaborating across engineering disciplines.…See more Requires a Bachelor's degree in Engineering or related field plus 1-2+ years of relevant engineering experience in product testing, design verification, systems engineering, or quality engineering, with strong analytical, technical writing, and cross-functional collaboration skills.

Senior Systems Engineer responsible for leading systems engineering activities on complex medical device and integrated products at BD. The role requires developing and executing reliability planning, driving cross-functional collaboration across engineering disciplines, investigating and resolving system performance issues, and mentoring junior engineers.…See more The position demands expertise in requirements management, system verification/validation, risk management (FMEA, hazard analysis), Design for Six Sigma methodologies, and model-based systems engineering, with 3-5+ years of relevant engineering experience and a strong technical background.

Senior Systems Engineer responsible for leading system integration planning, verification and validation strategy, and reliability engineering for complex medical devices or integrated systems at BD. Own cross-functional coordination across Reliability, Software, Electrical, Mechanical, Quality, Regulatory, Manufacturing, and Clinical teams while investigating system-level issues, managing technical risks (FMEA, hazard analysis), and mentoring junior engineers.…See more Develop requirements, drive design reviews, and apply Design for Six Sigma (DFSS) methodologies to enhance product quality and development efficiency from concept through commercialization.

This role combines risk management governance with specialty systems engineering (reliability, availability, radiation effects, cybersecurity) and model-based systems engineering (MBSE). The engineer will develop risk policies and mitigation strategies, conduct or facilitate reliability/availability/radiation/cybersecurity analyses, and translate these findings into SysML models in Cameo Systems Modeler for traceability and trade-study analysis.…See more The position requires cross-functional collaboration with program management, design engineering, and logistics to integrate specialty drivers into program baselines and compliance with standards like MIL-STD-785 and NIST RMF.

This Systems Integration Engineer II/III role centers on hands-on system validation, verification, and reliability testing for complex life-science instrumentation integrating hardware, software, firmware, optics, lasers, fluidics, and motion control. The engineer will conduct cross-functional troubleshooting, execute structured test protocols, analyze instrument performance data using statistical methods and Python, and document findings to drive design improvements and field support readiness.…See more Key responsibilities include evaluating workflows against real customer use cases, performing root-cause analysis on failure modes, and continuously refining integration documentation and testing practices. The role requires 2–5 years of systems integration or testing experience, proficiency in DOE/FMEA/statistical analysis, and hands-on lab work with prototypes and integrated instruments.

Lead complex quality investigations and root cause analysis for a medical device company, driving CAPAs, NCMRs, and systemic corrective actions. Provide technical leadership in quality engineering methodologies including Six Sigma, Lean Manufacturing, process capability analysis, and risk-based problem solving.…See more Own validation and qualification strategies for equipment, processes, test methods, and software V&V across the product lifecycle. Partner with R&D, Regulatory Affairs, Manufacturing, and Engineering teams on design transfer, commercialization, and compliance initiatives while representing Quality during audits and regulatory inspections.

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.