• Primary Technical Resource - Early stage redesign of a $150MM+ nuclear medicine combination product (drug/device). Conducted 25+ Voice of Customer (VOC) interviews and associated language processing at 6+ sites nationwide to validate product concept. Successfully designed and developed 30+ plastic injection molded/glass/cannula/die cast components. Designed, developed, and validated ten laboratory test methods for selected concept. Successfully brought product through proof of concept and into verification utilizing Design for Six Sigma (DFSS) methodologies. • Technical Lead - Tasked with redevelopment, validation, and global deployment of a product release test method addressing a significant CAPA preventing the release of a $200MM+ product. Successfully conducted test method development and validation utilizing DFSS methodologies at two US and two international sites concurrently within 6 months. • Technical Lead - Project scope development for a multimillion dollar combination product platform. Developed technical product concept to meet internal customer requirements. Developed detailed estimates on project cost, resourcing, and timing. Objective assessment of business and technical challenges presented to executive committee with recommendation to pause further investigation until more favorable business conditions developed.• Interim Laboratory Manager - Tasked with managing the transformation of an engineering support group of nine. Successfully removed silos, and developed individuals in new roles. Developed six new written policies and departmental guidance documents to facilitate onboarding of new individuals. Responsibilities included hiring two employees, establishing annual objectives, and annual performance appraisals for the team while managing two laboratory relocations.• DFSS Black Belt Mentor - Successfully co-mentored six candidates within the department to completion of their DFSS Black Belt within 18 months.