Managing a $16m revenue infection control product line, driving 60% YoY growth in 2019 and 6% in 2020 (despite COVID-19). Spearheaded multiple successful international launches.

▪ Leadership of a $1.2m immunological instrument development project including both internal stakeholders and external CMO management, leveraging three existing and two new lateral flow products. Supported development, supply, and quality contract drafting. Responsible for change management and budget control, keeping budget within 5% of target, and guided development program from initial concept to 510(k)-ready in 18 months.▪ Leadership of a $0.75m sample preparation development project including both internal stakeholders and external contract engineering firm▪ Leadership of concept development for a new $2.3m (forecast) molecular instrument project ▪ Active member of business intelligence / license & acquisition scouting team, including technical due diligence on three license & acquisition targets in the immunological diagnostics space

▪ Lead the Bacitsure™ Wound Lavage product from initial concept through to pre-launch, including identification of development partner, concept development, internal championing, identification of CMO, QMS integration, preparation of marketing materials, and drafting of 510(k) submission over a 24-month period. Also lead concept development for four follow-on products currently in evaluation.▪ Project lead for two additional infection control products (details confidential) in early R&D phase▪ Member of Advanced Technology team responsible for internal business needs assessment, business intelligence, identification of license & acquisition targets, initial relationship management, internal championing, and project handoff to internal business units.▪ Technical due diligence on 5 license & acquisition targets in the infection control space▪ Regulatory support for one novel internal development project, including preparation of regulatory strategy and FDA pre-submission letter▪ Represented corporate interests to ASTM, ORS, and various biofilm / surgical infection conferences with global attendance 2010-2012, Manager, External Research:▪ Steering a global system of investigator-initiated clinical trials and bench studies in support of all business segments, funding an average of $4m/year globally, including project development, internal review, regulatory and legal compliance, payment processing, and troubleshooting.▪ Initiated new study review processes, streamlined review cycles by 25%, and maintaining corporate compliance during a substantial corporate reorganization▪ Supported corporate UDI strategic response planning and Regulatory Intelligence▪ Represented corporate interests to ASTM

Teaching courses in Anatomy & Physiology, Project Management, and Statistics

Specializing in consulting services for orthpaedic biomedical engineering, including medical device design, failure analysis, expert witnessing, risk analysis, and regulatory affairs.

Design and deliver coursework in bioengineering. Direct a $1million spine research laboratory. Conceive and implement bioengineering research projects.

Product development for tissue engineered cartilage product.