ANDY SCHIEBER

FOUNDER & PRESIDENT

Co-Founder and President of Ingenarious Consultants. Andy has over 15 years of experience with R&D engineering development including Class III implantable medical devices, ophthalmic, neurovascular and dental accessories and equipment. That experience gives Andy a unique ability to see what lies ahead, from early-stage prototype development to scale-up process validation, allowing him to work with clients to optimize the development pathway and reduce costs and time-to-market. Andy is the Inventor on 41 patents including the Hydrus Microstent (Ivantis Inc.), and an author or co-author of 5 peer-review publications. Andy holds a MSME from the University of Minnesota.

RANDALL TAKAHASHI

FOUNDER & GENERAL MANAGER

Co-Founder and General Manager of Ingenarious Consultants. Randall has over 15 years of experience with Operations and Manufacturing engineering including Class III implantable medical devices, ophthalmic, neurovascular and cardiovascular implants, accessories and equipment. Randall has led manufacturing of medical devices from prototyping, to early stage pilot lines, and all the way to product commercialization. His experience across the manufacturing development process provides inventors with a roadmap for turning prototypes into realized products. Randall holds a BS in Biomedical Engineering from the University of California, San Diego (UCSD).

STEVE ZIEMBA

Steve has More than 30 years of experience in development and management of FDA/ISO-compliant quality systems, regulatory filings and clinical study programs (protocols/ICDs and data analysis systems) for Class I, II and III medical devices in US, EU, Canada, Japan, China, Australia, South Africa, Korea, Brazil and Mexico. He has worked with early stage and multinational ophthalmic, dental, orthopedic, general surgery and cardiovascular device companies. Steve has authored more than 10 original PMAs, numerous PMA supplements, IDEs, 510(k), Q-subs, and Technical Dossiers leading to FDA approvals and CE Marks with several Notified Bodies and other OUS approval agencies.

Steve’s expertise also includes FDA QSR and ISO13485-2016 and MDSAP compliance, 14971-2019 risk assessment/mitigation, protocol/statistical development for initial product design and scale-up validations, HE75 Human Factors studies, Meddev-compliant CERs, PMS/PMCF studies and MDR 2017/745 gap analyses. He has authored/co-authored more than 18 peer-reviewed papers and holds a M.Sc. in Systems Management from the University of Southern California.

MARCUS SOUZA

Marcus has over 18 years of broad R&D experience with 12 years in the ophthalmic and medical device industry. During his career Marcus has been a key player in the development of many successful ophthalmic and other medical devices including consumable and implantable devices, gaining expertise in mechanism design, medical device development, plastics design and design for manufacturing. His experience and attention to detail provides innovative but practical solutions to design and testing. Marcus holds a BSME from California State Polytechnic University, San Luis Obispo.

LUKE BILGER

Luke has 30 years of multidisciplinary Engineering experience in development of automated machinery, automated test equipment, robotics, data acquisition systems, instrumentation, and fixture and tool design for assembly and testing. He has developed production and R&D assembly and test equipment primarily for medical device manufacturing and aerospace, but also in other areas such as nano-material fabrication and electronics manufacturing.
Luke holds a BS in Mechanical Engineering, Design, Dynamics and Control from UCLA. With that mechanical grounding, Luke’s diverse experience also includes machine control programming with PLC’s and HMI’s, servo and stepper motion control programming, PID loop tuning and data acquisition and control programming using LabView. He can do electronic console design, electronic packaging, and control cabinet design.