Barry Fulkerson

About Barry Fulkerson

Medical Products R&D Executive: Accelerate Development + Launch of Class Medical Devices – Design to ProductionOffer direct medical device innovation and product development experience developing extracorporeal systems in a start-up and established environments. Based on partnership with clinicians, design progressive therapies that meet clinical / patient needs while viable in ever-evolving reimbursement environment.Operations executive skilled at leading and collaborating with cross functional teams, engineering, clinical, quality, sales, and regulatory, to design and produce complicated hardware with sophisticated human interfacing components – device and disposable.Hands-on leader who manages each step with an eye towards regulatory compliance (FDA and Global). Practiced at supporting international development efforts. Please contact me directly at b••••••••@gmail.com Specialties: Medical Device Equipment Development - Home Hemodialysis Development

Experience

1. Director, Systems Engineering

   Center For Dialysis Innovation

   Jan 2021 — Present · Seattle, WA, US

   Working with research collaborators, regulatory team, human factors team, engineers, clinicians, patients and executive management to efficiently manage cross-disciplinary projects to improve quality of life for people on dialysis.

Education

• Western Kentucky University

  Bachelor’s Degree, Electrical and Electronics Engineering

  1980 — 1984

Skills

• Medical Devices
• Capa
• Design Control
• Fda
• Product Launch
• Quality System
• Engineering
• R&D
• Cross-Functional Team Leadership
• Iso 13485
• Hemodialysis Machine Development
• Product Development