Team

Kevin Ranucci

Senior Principal Consultant

Kevin has worked over 25 years in the Medical Device and Combination Product industries at multiple global companies, including hands-on experience in Product Development, Mechanical Design Engineering, Manufacturing Process Development and Program Management for various types of medical devices and combination products (Autoinjectors, pre-filled syringes, and class II/III implantable surgical products). With a passion for driving results through design excellence principles, Kevin guides design and development teams in the pursuit of products that are user centric, reliable, safe and effective at achieving clinical outcomes.

Academic & Professional Qualifications:

  • B.S. Mechanical Engineering, Worcester Polytechnic Institute

  • 52 Granted Patents/Applications

Training, Quality Systems, & Specialties:

  • Combination Product / Medical Device Design and Development

  • Design Controls

  • Dfx – Six sigma

  • CAE – Computer Aided Engineering (CAD/CAM/Simulation, Tolerance Analysis)

  • Risk Management including Risk Analysis, uRRA, dFMEA & pFMEA

  • Human Factors / Usability Engineering

  • Manufacturing Process Development

  • Process Validation

  • Quality Engineering

  • Statistics

  • Program Management

  • Partnership / Alliance Management

  • ISO 13485: Medical Devices – Quality Management Systems

  • ISO 14971: Risk Management

  • ISO 11608: Needle-based injection systems

  • ISO 23908: Sharps injury protection

  • ISO 11040: Pre-filled syringes

  • IOS 10993: Biological evaluation of medical devices

  • ISO 62366: Application of usability engineering to medical devices

  • FDA 21 CFR Part 820: Quality System Regulation

  • FDA 21 CFR Part 4: Regulation of Combination Products

  • EU MDR / IVDR Regulations for medical devices and in-vitro diagnostic medical devices

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