design-control jobs in San Diego

Staff QA Engineer at Dexcom leading manufacturing quality and regulatory compliance for continuous glucose monitoring devices. Responsibilities include directing Design Control and design transfer strategy, managing process validation and commercialization, leading cross-functional teams on complex technical and compliance matters, and providing expert guidance on Quality Management System governance (FMEA, CAPA, process controls).…See more Requires deep hands-on experience with FDA 21 CFR 820, ISO 13485, and related QMS requirements, plus ability to mentor teams and represent the organization during audits and regulatory inspections.

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.