Director, Design Control, Risk Management & Human Factors Engineering
Ethicon Endo Surgery Inc
Jose M. Justiniano has 34 years of experience in leading R&D quality, manufacturing, and new product development at Bell Laboratories, Abbott Laboratories, Johnson & Johnson Ethicon Endo-Surgery, Hospira, Inc. (Pfizer) and now at Johnson & Johnson Vision. In his career, Jose has taken on increasing levels of technical, risk management, regulatory compliance and quality leadership in R&D and R&D QA, including more than 130 successful 510K and 5 PMA submissions in the areas of electro-surgery, minimally invasive coronary artery by-pass grafting, endoscopic vein harvesting, wound care, bariatric surgery, gastrointestinal endoscopy, incision-less surgery, laparoscopy, infusion pumps, drug-device combination products, contact lenses, combination products and immunoassay development. Jose is passionate about advancing the state of the art in medical technology. Many of his product launches have been first in humans.
Jose’s experience with regulatory authorities includes: FDA, multiple EU Notified Bodies (e.g. BSi, TUV, NSAI, CFDA (China), PMDA (Japan) and KFDA (Korea).
Jose is the co-author of two books in Medical Device Design:
• Practical Design Control Implementation for Medical Devices (2003, CRC Press)
• Six Sigma for Medical Device Design (2004, CRC Press)
Jose has been a medical device and pharmaceutical industry instructor and conference speaker of quality engineering, risk management (ISO 14971, ISO 31000), process validation, design controls, quality management systems (ISO 9001, ISO 13485) and statistical methods since 1990. He has trained more than 5,000 industry professionals nationally and internationally as well as more than 500 inspectors at FDA’s ORA University.
Risk Management – member of AAMI USA parallel work group to ISO TC 210revising ISO 14971:2019 and ISO 24971:2019
Monday, September 23
4:00 PM – 5:30 PM