• Professor of Practice
James Machek

Educational Background

  • B.S., Mechanical Engineering, Gannon University, Pennsylvania

Research Interests

    • Over 25 years of experience in the medical device industry.
    • Held leadership positions at Covidien, Medtronic, St. Jude Medical, and Boston Scientific in R&D and Operations
    • Experience with products encompassing the following therapeutic areas: cardiac rhythm management, endovascular, vascular surgery, cardiothoracic surgery, neurovascular, neurosurgery, interventional radiology and general surgery
    • Experienced with both PMA and 510(k) products, including implantable, capital equipment, systems with mechanical, hardware and software, reusable and disposables.
    • 25 issued patents

Industry Experience

  • • 20 years as R&D executive in Medical Device industry

    • 7 years as Operations leader in the Medical Device industry

    • 5 years leading Program Management office

Certifications & Memberships

  • Program Management, University of Wisconsin
  • Bio-design, Stanford University
  • Integrated Product Strategy, California Institute of Technology
  • Design for Manufacturability and Assembly
  • Six Sigma