fda-510-k jobs in San Diego

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.…See more 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.

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.