medical-device-compliance jobs in San Diego

Staff Quality Engineer for a medical device manufacturer responsible for owning and continuously improving the Quality Management System across the full product lifecycle. The role involves coordinating QMS processes and documentation, leading design control programs, managing change control reviews, directing CAPA activities, handling complaints and supplier qualification, and leading internal audit programs.…See more Requires 8–10+ years of medical device quality experience, 3+ years in quality system auditing, and strong expertise in ISO quality systems and FDA-regulated device standards.

Lead the development and release of a next-generation iOS application for an FDA-cleared insulin pump, building new patient-facing features while maintaining a legacy app and contributing to shared core components. Own end-to-end delivery with emphasis on medical device compliance (FDA, ISO), HIPAA security, and accessibility standards.…See more Write clean, well-tested Swift and SwiftUI code leveraging modern concurrency patterns, work with CoreBluetooth and CoreData, and collaborate across engineering, design, and product teams.

Senior Software Test Engineer at Illumina responsible for designing and executing comprehensive test strategies for complex instruments in a regulated medical device environment. The role requires troubleshooting across hardware and software boundaries, working hands-on with physical laboratory instruments, and managing defects and requirements through industry-standard platforms.…See more Candidates should have strong debugging and analytical skills, familiarity with embedded systems and communication protocols, and experience in regulated environments; AI-assisted tools and Linux command-line proficiency are valued additions.

Senior Software QA Engineer supporting Dexcom's Postmarket Investigations team to assess real-world product performance, investigate software and device issues, and drive continuous improvement. You will collaborate across R&D, Quality, Regulatory Affairs, and Clinical teams to conduct root-cause analyses, perform risk assessments (including hazard analysis, DFMEA, PFMEA), and translate postmarket insights into product enhancements.…See more The role requires deep technical understanding of software architecture, structured problem-solving, statistical analysis, and the ability to communicate findings to both technical and non-technical stakeholders while ensuring regulatory compliance and patient safety.

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.…See more Manage a team of compliance engineers and test professionals, oversee departmental budgets, and continuously improve compliance testing processes and best practices.