Isaac Gesser

Led the integration of lab robotics to automate probiotic vaccine production and testing Ensured compliance with FDA 21 CFR Part 11 and ISO 13485 standards (IQ, OQ, PQ, PPQ) Communicated technical developments to executives, physicians, and cross-functional teams

▪ Enhanced communication of key process indicators, technical developments and project status. ▪ Led Corrective and Preventive Action (CAPA) and risk analysis activities involved with technical support team.

▪ Major clients included Northrop Grumman, Siemens, Rockwell, Mitsubishi, JPL, and Universities including University of Manitoba, UCLA, and CALTECH. ▪ Programmed Siemens PLCs to control orientation of aircraft fuselages for assembly. ▪ Designed, programmed, and integrated Rockwell, Siemens, and Mitsubishi PLCs with user-friendly human machine interfaces and Supervisory Control and Data Acquisition (SCADA).

• I nitiated, stocked, and managed Edwards’ showcase APT (Advanced Process Technology) lab to help Edwards invent and find ways to modify or automate processes to improve product quality and production line efficiency - This lab used a FANUC M16iB 6-axis robot, a FANUC M-10 series delta robot, and an Allen Bradley ControlLogix PLC, with a variety of other off-the-shelf and custom robots, PLCs, servo motors, sensors, vision systems, liquid dispensers, ultrasonic welders, lasers (Excimer, UV, and IR), and custom pneumatic, servo, or stepper motor actuated grippers. • Led a team of 3 engineers, one engineering technician, and a machine builder through the specification, design, build, CAPA, FDA21 Part 11, ISO13485 (IQ, OQ, PQ, PPQ), and ISO9001 qualification, FMEA, and risk analysis activities for systems used in the production of artificial heart valves. • Given the Edwards E3 Award for Excellence for developing a fully automated system to process bovine tissues to make them universally biocompatible for any patient.

▪ Manager Of Essilor’s Operations Automation and Line Maintenance Teams. ▪ Led all CAPA, FMEA, and risk mitigation activities involved with the production floor. ▪ Led international cross-functional teams through the development of a fully automated lens inspection line and automatic storage and retrieval system.

Team Leader for Automation and Process Improvement. Received Star of Excellence Award for Innovation and Six Sigma Greenbelt. • Led a team of 4 engineers, one technical writer, and a machine builder through the specification, design, build, qualification, and determination of ISO 13485 qualification procedures for a 128-process fully lights-out production line capable of a production rate of 240 PPM from raw materials through shipping. • Independently debugged and calibrated a 28-station manufacturing robot with feeder bowls, ultrasonic welders, adhesive dispensers, and vision systems to ensure it performed meeting all specifications and FDA 14-11 and ISO 13485 regulatory requirements. • Initiated, stocked, and managed Minimed’s APT (Advanced Process Technology) lab to help Minimed find ways to modify or automate processes to improve product quality and production line throughput. >> This lab used a Mitsubishi SIA20D 7-axis robot, FANUC M16iB 6-axis robot, Staubli TX-60 5-axis robot, an Allen Bradley ControlLogix PLC, and a Delta Tau PMAC 2 embedded system with a variety of other off the shelf and built in house robots, PLCs, servo motors, sensors, vision systems, liquid dispensers, ultrasonic welders, lasers (Excimer, UV, and IR), and custom grippers. • Invented and developed mechanisms to automatically debond 2.5 cm long, 0.18 mm wide, 0.02 mm thick filaments from glass substrate and then insert them into a 0.2 mm diameter half-circle lumen of a 2.0 cm long double-lumen tube.

Co-Inventor Of The ibis T5000 Biosensor. Awarded Patent for the T-5000 Robotic System for Automatic Identification of Bioagents. This patent won the Wall Street Journal Gold for Innovation. • Led and managed the isis-ibis Biosciences operations, robotics, and automation team. • Designed, optimized, and maintained robotic workstations used to analyze DNA and RNA with a nuclear mass resonance (NMR) spectrometer. >> Each system used a Bruker NMR, Thermo Scientific CRS Catalyst 5 robot, Synquad/Cartesian robotic pipettor, and a Hamilton automated PCR system, all coordinated with a Siemens SIMATIC 505 embedded control system.

Graduation Thesis, Spinal Architecture for Machines That Walk.

My program had a heavy emphasis on Robotics,, Material Science, Automation Engineering, Control Theory, Thermodynamics, Stress Analysis, Mechanics, and Automotive Engineering, It also involved Computer Science which included the earliest design of AI deep learning and inference systems. I also took extra classes in microbiology and Political Science, specializing in Intelligence, Espionage, and Covert Activities.