medical-device-development 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.

Senior embedded software engineer responsible for designing, developing, and integrating embedded C/C++ software for next-generation intravascular ultrasound (IVUS) medical devices. The role requires 7+ years of embedded systems experience, strong hardware/software integration skills, expertise with microcontrollers, DSP, FPGA, and data acquisition systems.…See more Responsibilities include ultrasound signal processing, FPGA-to-console interfaces, diagnostics/test software development, and cross-functional collaboration with FPGA, electronics, systems, and manufacturing teams.

Associate Systems Engineer supporting the development and enhancement of in-vitro diagnostic (IVD) instruments within a regulated medical device environment. The role involves system integration testing, verification and validation (V&V) activities, troubleshooting, failure investigations, and risk assessments across multiple R&D projects.…See more Responsibilities include executing statistical analyses, performing root cause analysis, contributing to design control documentation and regulatory submissions, and collaborating with cross-functional teams (software, hardware, assay development, quality, manufacturing). Requires a Bachelor's degree in Systems Engineering, Bioengineering, Mechanical Engineering, Electrical Engineering, or related field with 0–3 years of relevant experience; Master's preferred.

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.

Staff Systems Engineer at BD will lead systems engineering efforts across complex medical device programs, driving reliability planning, product quality improvements, and cross-functional technical collaboration. The role requires deep expertise in requirements management, system architecture development, verification/validation, and risk management, with responsibility for mentoring junior systems engineers and championing MBSE and design methodologies.…See more The ideal candidate has 6–8+ years of systems engineering experience, preferably in regulated medical device development, and demonstrates exceptional ability to influence technical strategy across multiple disciplines without direct authority.

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 complex medical device development programs for Dexcom's Stelo wearable glucose biosensor platform, driving cross-functional teams through research, verification, validation, and commercialization. Direct R&D, commercial, operations, quality, clinical, regulatory, and legal stakeholders; manage product roadmaps, timelines, and executive governance; resolve technical and business tradeoffs while mentoring team members.…See more Requires proven experience shipping novel wearable or connected medical devices with expertise across mechanical, electrical, systems, and mobile app engineering disciplines, plus familiarity with FDA and EU MDR regulatory pathways.

This Systems Engineer role at a medical device company requires decomposing regulatory and stakeholder requirements into testable system specifications, leading design reviews and verification/validation activities, and supporting risk management under FDA and ISO frameworks. The position demands 2+ years in a regulated medical device environment, with responsibility for traceability documentation, design history files, failure investigation, and CAPA activities.…See more Key competencies include FDA design controls, ISO 14971 risk management, human factors/usability per FDA guidance, and cross-functional communication of complex system interfaces to diverse audiences.

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.

Lead the Sensor Technology workstream for Dexcom's Innovation, Ventures & Sensor Technology PMO, managing biosensing technology development from concept through product lifecycle. Own integrated program timelines, Work Breakdown Structure, and design controls compliance under 21 CFR 820 regulations.…See more Manage budget, resources, risk, documentation in the PLM system, and coordinate build/test activities while serving as the primary stakeholder liaison. This role requires significant medical device development expertise, strong project management skills across waterfall and hybrid methodologies, and preferably a technical background in Material Science or Electrochemistry.

Senior Manager leading systems engineering for complex Point-of-Care diagnostic instruments, overseeing hardware, software, consumable, and assay integration. Responsible for system architecture, cross-functional integration with external partners, regulatory compliance (ISO 13485, IEC 62366, IEC 60601, ISO 14971), and risk analysis.…See more Will mentor junior engineers, drive technical decision-making across R&D, Quality, Manufacturing, and Regulatory teams, and manage the full product lifecycle from concept through commercial launch in a regulated environment.

Staff Technical Program Manager leading early-stage technology development projects within Dexcom's Innovation Ventures & Sensor Technology group. Oversees complex, cross-functional projects from concept through productization, managing project schedules, regulatory compliance, and technology risks while coordinating internal and external stakeholders.…See more Requires strong technical background in biomedical engineering, chemistry, or materials science with medical device development experience, particularly in sensor and algorithm development.

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.