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.… 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.
iec-60601 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.
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.… 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.
Lead compliance testing and certification activities for a portfolio of medical devices, developing test strategies, managing external laboratories and certification bodies, and ensuring products meet FDA, safety, EMC, wireless, and regulatory requirements. Partner with Engineering, Quality, and Regulatory Affairs to identify compliance risks early and drive mitigation strategies.… Manage a team of compliance engineers and test professionals, oversee departmental budgets, and continuously improve compliance testing processes and best practices.