iec-62304 jobs in San Diego

Sr. Software Test Engineer I develops and implements software validation test plans for embedded medical devices, with responsibility for test strategy, automation, and cross-functional coordination.…See more The role requires expertise in test automation frameworks, understanding of embedded software architecture, and knowledge of medical device standards (IEC 62304). The engineer will lead test plan reviews, diagnose product failures, manage test documentation, and work closely with R&D and quality teams to ensure compliance with specification requirements.

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.

This Software Design QA Engineer role focuses on ensuring software development conformance to FDA, IEC 62304, and ISO 13485 standards in a medical device company. The engineer will lead design assurance activities including risk management (SHA, design FMEA), design control reviews, configuration management, and post-market compliance support.…See more The role requires expertise in medical device software development lifecycle processes, regulatory frameworks, and cross-functional collaboration with engineering, test, and regulatory teams.

Lead a medical-device iOS application as a senior engineer transitioning into engineering leadership. You'll own the architecture and technical direction of native Swift apps, device-to-cloud interfaces, and web services on GCP, while establishing CI/CD practices and collaborating with firmware and hardware teams.…See more The role requires proven experience shipping iOS/Swift products that integrate with medical devices and managing software end-to-end across mobile and backend platforms.

Lead the technical architecture and evolution of the ReActiv8 implantable medical device system across embedded firmware, mobile, web, and cloud infrastructure. Define software architecture strategies, translate clinical and regulatory requirements into compliant designs per IEC 62304 and FDA expectations, and establish coding standards and design principles for the engineering team.…See more Drive architecture reviews, design control activities, hazard analysis, and FDA regulatory submissions while mentoring software engineers across firmware, application, and cloud domains. Maintain development tools and practices including Azure DevOps, Git, and AI-assisted workflows in a regulated medical device context.

This Staff Engineer role owns and executes BD's product security lifecycle for FDA-regulated medical device dispensing systems and their cloud platforms. Key responsibilities include defining end-to-end security architecture, conducting threat modeling and risk assessments, implementing secure SDLC practices aligned to NIST/OWASP/BSIMM, managing SBOMs and vulnerability remediation, and ensuring regulatory compliance (IEC 62304, ISO 14971, FDA cybersecurity guidance).…See more The role requires 5+ years of cybersecurity experience with FDA Class I/II devices, hands-on expertise in embedded/cloud/application security, and the ability to balance security controls with usability while supporting FDA submissions.

Develop and optimize low-level embedded firmware in C++ for avionics systems, flight controllers, and mission payloads, focusing on performance, reliability, and safety-critical applications. Port frameworks and applications to new RTOSes and hardware platforms, create Board Support Packages (BSPs), adapt Hardware Abstraction Layers (HALs), and develop peripheral drivers for interfaces like I2C, SPI, UART, and ADC.…See more Conduct unit and integration testing including fault injection and MISRA C compliance checks, diagnose cross-domain issues across electromechanical, software, networking, and RF subsystems, and collaborate with hardware teams to validate firmware incorporating secure boot, watchdogs, and fault-tolerant designs. Requires 5+ years embedded systems development, U.S. citizenship, ability to obtain DoD security clearance, strong Linux/Windows proficiency, and expertise in Python, Bash, Shell, and C/C++.

The Senior Design Quality Engineer ensures digital health products comply with FDA regulations, quality standards, and user requirements through design controls and verification/validation activities. They manage digital health projects from concept to production using phase-gate approaches, lead or support CAPAs and NCRs, conduct internal/external audits, and apply risk management throughout the design lifecycle.…See more The role requires advanced knowledge of FDA design controls and IEC 62304 software standards, with hands-on experience taking products through regulatory compliance. The engineer will work independently, provide executive guidance on quality matters, and serve as a best-practice resource within their area of expertise.

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.

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.