Ning Yu

About Ning Yu

I have extensive experience in mechanical and electro-mechanical product development, with a focus on medical devices and combination products from concept to launch. I lead cross-functional teams, ensure robust design, apply human factors engineering, develop and validate manufacturing processes to bring innovative solutions to clinical trial and market launch, meeting both regulatory and organizational requirements. My expertise includes pen injectors, prefilled syringes, autoinjectors, on-body injectors, reconstitution kits, ocular delivery systems, implanted devices, connected devices, and smart packaging.

Experience

1. Vice President, Device & Combination Product Development

   BioCryst Pharmaceuticals, Inc.

   Jan 2026 — Present · Boston, MA, US

   Continued in role following acquisition of Astria by BioCryst in Jan 2026. Responsible for setting strategic and scientific direction, leading end‑to‑end device lifecycle activities, and making cross‑functional decisions that shape program and organizational outcomes. Provide technical and scientific leadership internally and externally, oversee risk management and quality alignment, collaborate across CMC, clinical, regulatory, commercial, and CMO functions, and represent the company in regulatory, industry, and scientific forums. Build and lead a high‑performing device development team, drive execution of key device programs, and influence major platform and partner decisions.

Education

• Boston University

  Master of Business Administration (M.B.A.), Health Sector MBA

  2014 — 2017

• University of Illinois Urbana-Champaign

  PhD, Mechanical Engineering

  2002 — 2005

• Zhejiang University

  Bachelor, Mechanical Engineering

  1996 — 2000

• University of Illinois Urbana-Champaign

  Master, Mechanical Engineering

  2000 — 2002

Skills

• Medical Devices
• Design Control
• Design for Manufacturing
• Orthopedic
• Biomechanics
• Minitab
• Design of Experiments
• Statistics
• Mechanical Testing
• Matlab
• Tribology
• Biomedical Engineering
• Cross-Functional Team Leadership
• Manufacturing
• Dmaic
• Manufacturing Engineering
• V&V
• Spc
• Injection Molding
• Pro Engineer
• Fda
• Labview
• Materials Science
• Capa
• Iso 13485
• Iso 14971
• Solidworks
• Quality System
• R&D
• Fmea
• Failure Analysis
• Validation
• Biomaterials
• Finite Element Analysis
• Mechanical Engineering
• Engineering Management
• Ansys
• Machining
• Root Cause Analysis
• Commercialization