design-controls jobs in San Diego

Staff Technical Program Manager leading early-stage technology development projects within Dexcom's Innovation Ventures & Sensor Technology group. Oversees complex, cross-functional projects from concept through productization, managing project schedules, regulatory compliance, and technology risks while coordinating internal and external stakeholders.…See more Requires strong technical background in biomedical engineering, chemistry, or materials science with medical device development experience, particularly in sensor and algorithm development.

Lead software development for an FDA-cleared blood testing platform, overseeing instrument software, application software, cloud connectivity, cybersecurity, and software quality systems. Manage the full software development lifecycle including requirements, risk management, design controls, verification and validation, and regulatory compliance.…See more Work closely with Quality and Regulatory Affairs on FDA submissions, audits, documentation, and post-market support. Direct strategy, roadmap planning, architecture, and release management for a regulated in vitro diagnostic (IVD) medical device.