iec-62304 jobs in San Diego

Lead iOS Software Engineer for a medical device startup, responsible for owning iOS application architecture and technical direction using Swift, designing native iOS apps, developing web services and device-to-cloud interfaces (preferably on GCP), and establishing CI/CD pipelines and engineering standards. You'll collaborate across firmware, hardware, and backend teams while conducting code reviews and ensuring security and maintainability.…See more The role combines senior individual contributor technical ownership with a path toward broader engineering leadership as the team scales.

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 Embedded Firmware Engineer responsible for designing, developing, and maintaining embedded software for medical and life-science products. You will contribute to firmware architecture, hardware/software interface definition, and participate in code reviews, testing, and design reviews while working with multidisciplinary teams.…See more The role requires strong embedded C/C++ proficiency, experience with formal software development processes, and hands-on debugging across real hardware systems. You'll also provide technical mentorship and help improve software engineering practices within Agile environments.

Sr. Software QA Engineer responsible for ensuring medical device software products meet regulatory requirements and quality standards throughout the development lifecycle.…See more Reviews design control deliverables, risk management documentation, verification and validation activities, and software anomalies for compliance with FDA, ISO, and company procedures. Participates in design reviews, traceability analysis, CAPA investigations, and process improvement initiatives while supporting audits and regulatory inspections.

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.

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.

Senior Software Engineer role at Philips building full-stack ECG solutions for medical devices. Design, develop, and maintain robust applications using Java, Spring Boot, JavaScript, and Angular, implementing microservices architecture and APIs with GraphQL and RabbitMQ.…See more Lead deployment on AWS (EKS, RDS) with focus on CI/CD, security, and compliance with medical device standards (IEC 62304, HIPAA). Requires 5+ years software engineering experience, cloud expertise, and familiarity with regulated healthcare environments.

Lead the testing strategy and execution for embedded medical device software, with responsibility for designing automation-ready test cases, implementing automated test suites, and ensuring compliance across instrument functionality, cloud connectivity, and system interoperability in an FDA-regulated environment. Author and execute test plans covering documented requirements, collaborate with engineering and quality teams, and maintain automated test frameworks using tools like Squish and Robot Framework.…See more Requires 7+ years of software testing experience, proficiency in Python scripting, embedded software testing expertise, and hands-on work in Linux-based environments with Agile development teams.

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.

Lead iOS (Swift) Software Engineer for a medical device startup, owning architecture and technical direction for native iOS applications and device-to-cloud interfaces. You'll design and build iOS apps in Swift, develop web services on GCP, lead software decisions across mobile/backend/system integrations, and collaborate with firmware and hardware teams.…See more The role combines senior individual contributor responsibilities with growing engineering leadership as the team scales, including establishing CI/CD pipelines, code review standards, and security best practices.

Senior Firmware Engineer responsible for developing and optimizing low-level embedded C++ software for avionics systems, flight controllers, and mission payloads. The role involves porting frameworks to new RTOSes and hardware platforms, creating BSPs and HALs, designing peripheral drivers (I2C, SPI, UART, ADC, wireless protocols), and conducting safety-critical testing including MISRA C compliance.…See more Requires 5+ years of embedded systems experience, strong Linux/Windows proficiency, Python/Bash scripting, and ability to diagnose cross-domain issues across electromechanical, software, networking, and RF subsystems.

This role leads product security engineering for FDA-regulated medical devices (Class I/II) and their cloud-connected platforms. The engineer owns the full security lifecycle—threat modeling, risk assessments, security architecture, secure SDLC integration, and regulatory documentation—balancing patient safety, data protection, and FDA compliance.…See more Responsibilities span device and cloud security, vulnerability management, SBOM processes, and cross-functional collaboration with engineering, quality, and regulatory teams. Required: 5+ years cybersecurity experience, hands-on work with embedded/cloud/application security, FDA submission experience, and medical device development background.

Sr Software Test Engineer I leads test projects for an automated insulin delivery system, defining schedules, developing validation test plans, and overseeing test automation frameworks and CI systems. The role requires expertise in embedded or cloud-based programming (JavaScript, C, or C#), familiarity with IEC 62304 medical device standards, and the ability to identify software architecture impacts across the platform.…See more Responsibilities include managing cross-functional test reviews, conducting software audits, assisting with failure diagnosis and replication, and preparing detailed test reports for product evaluation. The position demands 7+ years of QA/test engineering experience, with proven expertise in test automation frameworks and scripting languages.

Lead verification and validation of cloud-connected medical device systems, designing and executing comprehensive test plans while developing automated test frameworks in Python. Test Microsoft Azure cloud applications, APIs, and infrastructure alongside embedded medical device software in regulated environments.…See more Mentor other test engineers, support CI/CD pipelines, and perform root cause analysis on defects. Requires 10+ years in software testing/QA, deep Azure and Python expertise, hands-on embedded medical device testing experience, and SDLC/V&V process knowledge.

The Software Release Manager owns end-to-end release planning, execution, and risk management for complex medical device software. The role requires technical understanding of system architecture and integration points to assess progress and anticipate risks, while coordinating across engineering, quality, regulatory, and product teams.…See more Responsibilities include managing schedules, budgets, vendor relationships, and ensuring compliance with FDA, ISO 13485, and IEC 62304 standards. The candidate will champion Agile and DevOps best practices, provide data-driven status reporting, and coach teams in hybrid Scrum environments.

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.

Lead Android Software Engineer responsible for designing, developing, and maintaining Android applications for medical devices using Kotlin. Own complex features end-to-end from requirements through implementation, verification, and post-market support, with emphasis on hardware communication via BLE and other protocols.…See more Collaborate with embedded, cloud, systems, quality, and regulatory teams to ensure software reliability in a regulated environment. Requires 7+ years of professional Android development, advanced Kotlin proficiency, strong architecture knowledge, and experience with automated testing and CI/CD workflows.

Senior Software Engineer responsible for architecting and implementing complex Android applications in Kotlin for medical devices, with emphasis on reliability, security, and regulatory compliance. The role involves collaborating with embedded and systems engineers to integrate Bluetooth Low Energy (BLE) and other communication protocols with medical device hardware, designing testable architectures, and ensuring compliance with medical device standards like IEC 62304 and FDA requirements.…See more Responsibilities include leading design reviews, conducting root-cause analysis on field issues, implementing comprehensive testing strategies, and maintaining technical documentation for regulated environments.

Senior Embedded Software Engineer responsible for developing complex real-time embedded systems for electroporation therapy delivery, including firmware, device drivers, middleware, embedded UI applications, and system-level software. The role requires 7+ years of embedded software development experience with modern C++, ARM Cortex-M processors, RTOS frameworks (ThreadX, FreeRTOS, etc.), and expertise in real-time control systems, closed-loop feedback, safety-critical software, and cybersecurity implementation.…See more Responsibilities span architecture design, hardware-software integration, verification and validation, CI/CD support, and cross-functional collaboration with electrical, mechanical, and regulatory teams. The candidate must demonstrate proficiency with embedded development tools, debugging hardware, IEC 62304/IEC 60601 compliance standards, and FDA cybersecurity guidance.

Principal Systems Engineer leading full product development lifecycle for a Class II Medical Device, defining system architecture and engineering strategy across electrical, firmware, software, and manufacturing domains. Owns multidisciplinary systems end-to-end, establishing development processes (CI/CD, automated testing, version control), leading embedded hardware and firmware architectures, and ensuring FDA compliance and Design Controls adherence.…See more Serves as primary technical authority coordinating internal teams and external partners, conducting design/architecture reviews, supporting manufacturing scale-up, and mentoring cross-functional engineers. Requires 12+ years of multidisciplinary product development with demonstrated systems engineering expertise, regulated-industry experience, and technical leadership without direct authority.

Lead iOS/Swift Software Engineer for a medical device startup, responsible for owning architecture and technical direction of native iOS applications and device-to-cloud interfaces. You'll design and build Swift-based apps, develop web services (preferably on GCP), lead cross-functional collaboration with firmware and hardware teams, and establish engineering best practices including CI/CD pipelines and security standards.…See more The role combines senior individual-contributor technical ownership with a path toward broader engineering leadership as the team scales.

Director-level role leading a software engineering team at a life sciences company building multi-omic analysis platforms. Requires hands-on full-stack expertise (React, Go, AWS, Temporal) alongside team management, architecture ownership, and end-to-end product delivery.…See more Must drive regulated software compliance (IEC 62304, ISO 13485, FDA 21 CFR Part 820), design controls, and V&V documentation while prototyping with AI tools and scaling agentic workflows within the team.

Director of Software Engineering leading end-to-end delivery across customer-facing products and internal tooling at a life-sciences company. This role combines hands-on full-stack development (React, Go, AWS, Temporal) with team leadership, architecture ownership, and regulated software compliance (IEC 62304, ISO 13485, FDA 21 CFR Part 820).…See more Candidates should have 10+ years of software engineering with 3+ years managing teams, fluency with modern AI coding assistants, and experience shipping instrumentation, cloud SaaS, and ML/AI features.

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.

Senior Software Engineer role building full-stack ECG and cardiac monitoring applications for medical devices. Design, develop, and maintain scalable microservices using Java/Spring Boot, JavaScript/Angular, and GraphQL, with deployment on AWS/Kubernetes (EKS).…See more Lead development following IEC 62304 medical device standards, HIPAA compliance, and CI/CD best practices. Requires 5+ years full-stack experience, deep expertise in Java and Angular, microservices architecture, AWS cloud technologies, and familiarity with regulated medical device software development.