Nicholas Ciccarelli, PE, President and Co-Founder of Neuma, an engineering services company, is a principal product development engineer with 12 years of experience in the fields of medical devices and drug delivery. He focuses on analytical design and the development of devices for high-volume manufacture while prioritising design for manufacturing and design for assembly. He has worked extensively on cross-functional teams that span the US, Europe and China. His experience includes individual component design (including plastic injection moulding, stamping, machining, glass, rubber), sub-assembly layout and top-level system integration. He has been heavily involved in design verification activities, in vivo study design and execution, and the preparation of premarket notification submissions.