Ali Mirnajafi

About Ali Mirnajafi

R&D Team Leader and engineering professional with extensive experience in the medical device industry, and strong academic background. Expertise in test method validation, V&V, prototyping, CAD, product Development, biomaterials, tissue biomechanics, tissue engineering, development of bioreactors, and finite element modeling. Key strengths include management, problem solving, and innovation. Hands-on troubleshooter with established track record in medical device R&D and dealing with FDA and other regulatory bodies. I am open to contracting or consulting jobs.Specialties: Medical device R&D, manufacturing, process validation, design control, tissue engineering, heart valve bioprosthesis, transitional research, finite element modeling, and teaching engineering.

Experience

1. Director

   Roytronix Inc

   Nov 2023 — Present

   Lead all activities on design, develop, and commercializing a totally new surgical device.Developed some concepts based on Surgeon\'s feedback and developed the first generation of the surgical tool.

Education

• Flinders University

  PhD, Cardiovascular Engineering

  1996 — 2000

• Sharif University of Technology

  BE, Mechanical Engineering

  1984 — 1989

• UNSW

  Master, Biomedical Engineering

  1993 — 1995

Skills

• Quality System
• V&V
• Process Simulation
• Fda
• Design Verification
• Engineering
• Root Cause Analysis
• Design of Experiments
• Manufacturing
• Ansys
• Product Development
• Biomechanics
• Research
• Engineering Management
• Design Verification Testing
• Labview
• Matlab
• Medical Devices
• Capa
• Tissue Engineering
• Simulations
• R&D
• Biomedical Engineering
• Design for Manufacturing
• Biotechnology
• Process Engineering
• Mechanical Engineering
• Solidworks
• Iso 13485
• Biomaterials
• Materials Science
• Life Sciences
• Mechanical Testing
• Spc
• Finite Element Analysis
• Statistics
• Product Design
• Six Sigma
• University Teaching
• Validation