Zachary Yanagihara

Led a cross-functional startup team through the full product lifecycle for a novel early stage lung cancer LDT. Built operational infrastructure for a state-of-the-art mass spectrometry and automation lab, accelerating assay development timelines and enabling scalable diagnostic workflows. Navigated a lab team through a successful CLIA lab accreditation process, enabling commercial operations.

Managed concurrent projects that supported the launch of GRAIL’s first multi cancer early detection LDT, Galleri®. Led system integration efforts for the successful launch of a scalable commercial laboratory designed to process over 1 million patient samples per year. Drove design improvements to rework the specimen collection kit, resulting in an annual cost savings of $850K.

Led a cross-functional manufacturing team for the development and production of Abbott’s HeartMate 3 LVAD chronic heart failure medical device. Drove design and process improvements for both internal and external manufacturing sites of critical device components, resulting in a 75% reduction in final QA inspection failures. Collaborated with New Product Introduction (NPI) teams to scale up new pro

Developed components, manufacturing processes, and validation procedures for Applied Medical’s Voyant laparoscopic surgical devices product line. Led design reviews and cost analysis to implement part replacements, resulting in 60% reduced material costs.

Implemented Lean Six Sigma process to save $225,000 annually in reduced scrap and operator touch time. Redesigned manufacturing floor layout to implement Auto-Kanban material system, improving product assembly times by 20%.

Completed a Bachelor of Science degree focusing on Biomedical Engineering. Gained foundational knowledge in engineering principles applied to biological and medical systems.