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.… 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.
iec-81001-5-1 jobs in San Diego
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.… 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.