Ryan Siskey

About Ryan Siskey

With over twenty years of experience as a consultant in the field of life sciences at…

Experience

1. Principal and Philadelphia Office Director

   Exponent

   Jan 2016 — Present

   In addition to being a Principal in the BME practice, I am the Director of the Philadelphia Office. As a Director, I work to develop staff, ensure the consulting practices in Philadelphia are growing and work to improve office operations. If you have engineering, science, regulatory, or business issues and are in the mid-Atlantic region, please contact us. Our team in Philadelphia would be happy to assist. My primary focus is medical device consulting projects requiring advanced mechanical and chemical characterization of products. I supervise the ISO 17025 accredited ISO (A2LA Certificate 2561.01) medical device testing laboratory in Exponent’s Philadelphia office. I have extensive experience in performing wear and material testing in accordance with ASTM and ISO standards, conducting cadaveric testing, and developing customized protocols. I am a lead ISO 13485 auditor and assist device manufacturers with quality system development and improvement. I maintain a broad range of testing expertise in testing devices from concept through post market surveillance and has assisted his clients in obtaining regulatory approval. I also have experience in failure analysis of devices which is often used to help client’s conduct root cause investigations of their devices and respond to FDA deficiency letters. While standardized testing plays a key role in characterizing most devices, new devices and new questions about existing products makes custom protocols a necessity in the lab. I have experience with developing these protocols for devices and products, from Class I to Class In my role as a laboratory supervisor, I am responsible for maintaining the Philadelphia Laboratory’s ISO 17025 accreditation with A2LA and conformance to 21 CFR part 58 U.S. FDA Good Laboratory Practices (GLP).

Education

• Drexel University

  BS, Biomedical Engineering

  2000 — 2005

• Drexel University

  MS, Biomedical Engineering

  2005 — 2008

Skills

• Testing
• Biotechnology
• Biomedical Engineering
• U.s. Food and Drug Administration (Fda)
• Failure Analysis
• Characterization
• Fatigue Testing
• Fractography
• Particle Size Analysis
• Glp
• Biomedical Applications
• Design Control
• Atr-Ftir
• Design of Experiments
• Mechanical Testing
• Research and Development (R&D)
• Orthopedic
• Iso 13485
• Iso Standards
• Biomaterials
• Good Laboratory Practice (Glp)
• Tissue Mechanics
• Life Sciences
• Medical Devices
• Bioengineering
• R&D
• Fda
• Iso
• Tensile Testing
• Lifesciences
• Ftir
• Differential Scanning Calorimetry