in-vitro-diagnostics-ivd 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.

Senior Manager leading systems engineering for complex Point-of-Care diagnostic instruments, overseeing hardware, software, consumable, and assay integration. Responsible for system architecture, cross-functional integration with external partners, regulatory compliance (ISO 13485, IEC 62366, IEC 60601, ISO 14971), and risk analysis.…See more Will mentor junior engineers, drive technical decision-making across R&D, Quality, Manufacturing, and Regulatory teams, and manage the full product lifecycle from concept through commercial launch in a regulated environment.