hazard-analysis jobs in San Diego

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.

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.

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.

The Systems Engineer applies systems engineering discipline to define, develop, integrate, and test complex in vitro diagnostic medical devices. Responsibilities include capturing user requirements, authoring system and subsystem requirements documentation, conducting hazard and risk analysis, managing configuration and change control, driving system integration and root-cause analysis, and coordinating with development, testing, clinical, and cross-functional teams.…See more The role requires a BS in engineering, 10+ years of industry experience, proven medical device development background, and proficiency in systems engineering methodologies including requirements decomposition, architecture, design reviews, and risk management.

Lead the architecture and technical strategy for a next-generation Class III implantable medical device, owning software design across embedded firmware, mobile, web, and cloud infrastructure. Establish architecture frameworks, design principles, and coding standards while translating clinical, regulatory, and business requirements into IEC 62304–compliant, FDA PMA–ready solutions.…See more Drive technical decision-making, conduct architecture reviews, and mentor a software engineering team across multiple domains. Support FDA submissions, design control activities, and cybersecurity integration throughout the system.

The Principal Software Engineer leads architecture and technical strategy for a Class III active implantable medical device, overseeing embedded firmware, mobile, web, and cloud systems. The role requires translating clinical, regulatory (IEC 62304, FDA PMA), and business needs into compliant, scalable designs while establishing architecture frameworks, design principles, and coding standards for the engineering team.…See more Responsibilities include leading architecture reviews, design control activities, hazard analysis, verification strategy, and mentoring across firmware, application, and cloud domains. The position demands 15+ years of software engineering with 8+ years in regulated medical device environments, hands-on expertise in .NET/C#/Blazor, Azure services, embedded firmware, cross-domain system integration, and strong cybersecurity practices for connected implantable devices.

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.

The Systems Engineer applies interdisciplinary expertise to define, develop, integrate, and test complex In Vitro Diagnostic systems for medical device applications. Responsibilities include documenting user and system requirements, decomposing system architecture into subsystems with defined interfaces, conducting hazard and risk analysis, managing configuration and change control, driving system integration and root-cause analysis, and supporting clinical validation.…See more The role requires 10+ years of industry experience with demonstrated mastery of the full product development lifecycle in medical device or regulated environments, including risk management, design reviews, and cross-functional collaboration with development, testing, and clinical teams.