Michael Vansickler

Background

About Michael Vansickler

Engineering leader with experience leading large engineering efforts from concept to commercialization in the FDA-regulated space. I have led as a manager overseeing direct reports and large programs of 100+ engineers via influence and observable technical excellence as in a matrix organization. Throughout my career, I have been able to see the larger picture and bring together the technical resources and the leadership support to convert ideas and wants into successful commercial platforms in the IVD diagnostics space. The BD Viper LT instrument and program was a counter-proposal that I originated in response to an ongoing external acquisition search to ensure that BD leadership had options for the evolution of the Viper XTR molecular platform. The concept was accepted and I led the engineering development of the platform. The team comprised internal BD resources and Hamilton Company as external development partners. The BD COR program originated as a marketing request for a highly automated platform to handle all sample handling and prioritization before performing BD molecular tests. The high-level requirements for the platform were filled in with personal research and domain knowledge of practical constraints of laboratories in the US and Europe. The platform, which consisted of three instruments that could be assembled at installation into seven different configurations, was approved for development and successfully launched in time to address the critical change in German HPV diagnostic testing. Working with existing engineering functions I shaped the organization structure for the 130+ engineers within the program to ensure that communication and productivity were ensured both internally and with the portion of the team at KMC Systems (an engineering and manufacturing partner on the program). The BD COR program won the Howe Gold award at BD for R&D technology development with commercial and business impact due to the innovations in the platform that supported both future engineering efforts at BD and program post-launch support. I am the inventor of 19 invention and design patents in the Medical Diagnostic field and was the primary engineer responsible for the distillation of the inventions for filling. I am glad that the products I have championed are making a difference in people’s lives, and I look forward to the next challenging opportunity to help more people. Specialties- Engineering management / Project & Program Management - FDA class II & device design, development, verification, and manufacturing