verification-and-validation-v-v jobs in San Diego

Sr. Research Associate will design and execute design-of-experiments (DOEs) to optimize surface chemistry processes for in vitro diagnostic systems, transitioning formulations from R&D through pilot scale-up and manufacturing under GMP/FDA design control.…See more The role requires hands-on expertise in fluorescence imaging/spectroscopy, microfluidics, molecular biology techniques (nucleic acid extraction, PCR, amplification), and consumable characterization—including test method design, acceptance criteria definition, and root-cause analysis. The candidate will author technical documentation (protocols, batch records, DHF submissions), collaborate cross-functionally with assay development, reagent chemistry, device engineering, manufacturing, and quality/regulatory teams, and support FDA submissions (510(k)/PMA, CE-IVDR). Strong systematic troubleshooting, laboratory skills, and ability to present data to leadership are essential.

Lead complex medical device development programs for Dexcom's Stelo wearable glucose biosensor platform, driving cross-functional teams through research, verification, validation, and commercialization. Direct R&D, commercial, operations, quality, clinical, regulatory, and legal stakeholders; manage product roadmaps, timelines, and executive governance; resolve technical and business tradeoffs while mentoring team members.…See more Requires proven experience shipping novel wearable or connected medical devices with expertise across mechanical, electrical, systems, and mobile app engineering disciplines, plus familiarity with FDA and EU MDR regulatory pathways.