Jesse Rosen

About Jesse Rosen

With over two decades of experience in medical device design and development, operations management, and manufacturing transfer, my focus and passion has been creating scalable platform designs for first-to-market products. I have demonstrated success launching and scaling a broad range of complex electro-mechanical systems and high-volume consumable devices.As SVP of Product Development and Operations at Candesant Biomedical, I led the developement, regulatory clearance, and manufacturing scale-up of a novel hyperhidrosis patch. Previous to this at R2 Technologies, I designed and launched an electro-mechanical skin cooling platform currently seeing significant market success. I have repeated successes empowering teams and fostering cross-functional collaboration to bring new medical devices to market, and to improve upon existing devices and systems.

Experience

1. Senior Director, Research and Development

   Alpfa Medical

   Dec 2025 — Present · Palo Alto, CA, US

Education

• Tulane University

  Master of Science - MS, Mechanical Engineering

  1996 — 1998

• UC San Diego

  Bachelor of Science - BS, Mechanical Engineering

  1991 — 1996

Skills

• Healthcare
• Medical Device Product Development
• Research and Development
• Biomedical Engineering
• Product Design
• Product Launch
• Quality System
• V&V
• Product Management
• Team Building
• Design Control
• Product Development
• Fda
• U.s. Food and Drug Administration (Fda)
• Validation
• Design for Manufacturing
• R&D
• Engineering
• Medical Devices
• Capa
• Process Improvement
• Biotechnology
• Research and Development (R&D)
• Manufacturing
• New Business Development
• Cross-Functional Team Leadership
• Iso 14971
• Commercialization
• Verification and Validation (V&V)
• Start-Ups
• Regulatory Affairs
• Iso 13485