Mechanical Engineering Director
Paul has over 20 years of industry experience specific to medical device engineering. His knowledge in Design & Development Engineering; along with applied statistics and raw material & manufacturing knowledge; have developed an extensive skill range. His experience includes development of user and product requirements; risk analysis; product design; CAD; finite element analysis; statistics; plastic and metal materials; design for manufacturability; part qualification; pilot builds; product verification and validation; benchtop, cadaver, in-vivo, and usability testing.
Paul has held engineering leadership and managerial roles at Frantz Medical Development and Johnson & Johnson, Ethicon Endo-Surgery. Over the past ten years, Paul has been personally responsible for managing and completing new product development projects, including a spinal implant device and instruments and a cardiovascular interventional guidewire and catheter system. As a Program Manager, Paul is responsible for developing schedules, establishing the critical path, and coordinating activities with internal and external engineers, cross-functional team members, and suppliers. Paul also plays an active Mechanical Engineering role with development projects – including SolidWorks 3D modeling, verification and validation method development and criteria establishment, and ensuring a successful design transfer by working closely with production on assembly procedures, fixtures, and tools, and pilot production qualification. Paul has managed a patent portfolio, as well as drafted and filed multiple patent applications to strengthen coverage and block competition.
Within the area of Regulatory Affairs and Quality Systems, Paul has established Quality System Design Control and Risk Management Procedures, as well as generating supporting objective evidence (e.g., Design History Files, Risk Management Files). These procedures have successfully passed audits by FDA, ISO notified body, and large company distributors, e.g., Abbott, CooperSurgical, and Medtronic.
Paul is also skilled in preparing research and product development grant applications, including solid research plans, establishing leading clinical and research teams, as well as budget and schedule development. His grant preparation skills have been demonstrated by successfully achieving a Cleveland Clinic Global Cardiovascular Innovation Center (“GCIC”) grant, NIH Small Business Innovation Research (“SBIR”) grant, as well as an Ohio Third Frontier Grant, totally more than $1.5 million dollars in non-dilutive funding.
Paul holds multiple patents for novel design and technology. In addition, he has contributed to publications on prototyping, design and machine tool monitoring.
Paul earned his Master’s and Bachelor’s degree in Mechanical Engineering with honors from University of Illinois.