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-62366 jobs in San Diego
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.… Responsibilities include leading design reviews, conducting root-cause analysis on field issues, implementing comprehensive testing strategies, and maintaining technical documentation for regulated environments.
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.