iec-62304 jobs in San Diego

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.