Resume

Name: Ezra Gershon

EMAIL Address: adh4sm@r.postjobfree.com

Citizenship: USA

Relocate: Yes

Education: BSc Electrical Engineering, MS Computer Science

& MBA

Professional affiliation: Past IEEE Society Chapter Chairperson: Engineering in Medicine & Biology (EMB-18)

Patent: Frequency Synthesizer

Current Employer/contract: DENTSPLY Sirona – A Medical Device Company specialized in 2D and 3D radiology imaging

WORK EXPERIENCE:

May 12-2017 – To date Sirona Dental, LI City, N.Y

A public company specialized in digital radiography imaging for the dental industry

Consultant/contract Engineering & Operation management. Oversaw and participated in the design of a handheld battery operated WiFi radiology imaging product. Improved the reliability of a GHZ wired CML link Bit Error Rate (BER) and designed a RF tested for the specialized cable. Performed engineering and operational troubleshooting as needed.

Wrote and reviewed System Requirement Documents (SRD), Manufacturing Test Procedures

(MTP), Risk Management documents, operational and technical manuals and engineering design documents. Participated in writing and reviewing and FDA approval documentations including 510K submissions.

June 2004 – To May 12, 2017 Sirona Dental, LI City, N.Y A public company specialized in digital radiography imaging for the dental industry

Electrical Engineering Department Manager/Director I was hired as part of initiatives for turnaround. There was a need to change the culture of the group and improve their engineering skills.

My department is responsible for the development electrical circuitry for 2D & 3D wired and wireless digital X-Ray cameras and intra-oral colour video cameras for dental applications. In this position I oversee that newly designed products meet business goals while conforming to medical and regulatory requirements. In addition to new product development the responsibility includes the transitioning of new products to manufacturing, design of automated test fixtures, and training customer support. Today, the company is the undisputed leader in digital radiography for dental applications.

Wrote and reviewed System Requirement Documents (SRD), Manufacturing Test Procedures

(MTP), Risk Management documents, operational and technical manuals and engineering design documents.

Key accomplishments/derived from responsibilities:

• Staffed the department with first class engineers and changed the group’s culture

• Under my leadership the department released over 16 world class products with very high profit margin..

• Provided proper analytical tools and training to the group such as: Simulation software for analog circuits design and VHDL code, Mathematical tools and in-house training courses for Digital Signal Processing (DSP), Mathcad and Verilog, and National Instrument software courses for improved testability and automation.

• Introduced in-house regulatory pre-scan tests for verifying product design for conformity to safety, EMC, FCC, UL and CE and other medical requirements. In the past three years, new designs pass EMC and safety tests requirements in two visits to certifying bodies- laboratories, saving time and money.

• Translated marketing requirements input into design requirement documents, setting the templates for new design. Participates as a staff member in setting the direction of next generation products.

• Interfaced with manufacturing engineering & QA throughout each of the development projects and during post release to production. I also oversee sustained engineering tasks. My group develops automated test equipment for testing wafers, dies, and subassemblies. These National Instrument based test-sets are first used as part of the engineering development phase and debugging effort. They are upgraded and ruggedized to be used in manufacturing.

• Interfaced with the German parent company. Helped define collaborative efforts, product differentiation, project responsibilities and schedules

• Outsourced services for optic design.

• Introduced WiFi wireless version of the digital X-Ray camera products.

• Wrote over 50 technical problem solving papers. That includes circuit, electromagnetic, mechanical, motion control, and thermal modelling and analysis, simulation and validation techniques.

• Applied and received FDA exception to ROHS compliant requirement for a complex miniature circuit board, saving over $4M

• Solved thermal and mechanical stress problems

• Devised test strategy for product reliability improvement.

• Contributed to clinical trials when introduced 3D radiology imaging system 1987-2004 ITS VP of Business development with P&L Responsibilities Farmingdale, N.Y

I managed the engineering & manufacturing groups that specialized in high-speed imaging and communication systems.

As part of the responsibilities, I developed the marketing strategy of sales through OEM and dealerships worldwide. My support for the sale’s channel development included proposal preparations and negotiations with major international accounts. I secured orders from the world largest customers domestically and internationally in countries including Germany, Finland, Italy, Turkey, Sweden and Denmark. I cultivated working relationship with international industry leaders such as Scan Graphics-Germany, Scitex- Israel, Autologic-Europe, Kodak and Agfa. This led to the development of complementing products that were sold by OEMs worldwide. I recruited and mentored staff members for the engineering and manufacturing groups. The company was successfully sold in May 2003 and I liquidated my interest. 1984-1987 Konica Imaging Vice President of Operations Glen Cove, NY

I oversaw the engineering, manufacturing and procurement groups. The company developed and manufactured advanced high-speed laser imaging equipment for graphic art applications. I directed the development of new products and quadrupled the production output. Direct reports: production, quality control, engineering and purchasing managers.

BS Electronic Engineering Polytechnic Institute, NY 1979 MS Computer Science Polytechnic Institute, NY 1981 MBA E-Commerce JIU, 1st accredited On Line University 2004 Computer skills:

Microsoft Office, Excel, PowerPoint, Microsoft Project and Publisher, Orcad, 3D CAD, Visio 2000, MathCad, MatLab, Rockwell Automation Micrologix 500 for PLC and workbench SPICE simulation, C, C++ and Python

Courses: Failure Mode and Effects Analysis (FMEA)

Lean Six Sigma

Creativity Unbound –An introduction to creative Process ISO 14971 Application of Risk Management to Medical Devices Aldec VHDL

Thermal Analysis and Design

Antenna Design

Xilinx FPGA/CPLD Design-Vivado

Xilinx Embedded control with Zynq 7000 series

Education

Python for AI and image recognition

Xilinx workshop for Vitis

Silab workshop for Bluetooth

Teledyne RF workshop

Patent: Frequency synthesizer

Association: IEEE chairman of Engineering in Medicine and Biology on Long Island for 3 years Hobby : Sport club and Electric/ Classic Guitar

Extensive working experiences designing medical devices that are in compliance with:

• IEC 60601-1 Medical Electrical Requirements – Part 1: General Requirements for Basic Safety and Essential Performance

• IEC 60601-1-6 Medical Electrical Equipment – Part 1-6: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Usability

• IEC 60601-1-2 Collateral Standard: Electromagnetic Compatibility, Requirements and Tests

• CISPR 11: Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement

• IEC 61000-3-2 Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current 16 A per phase)

• IEC 61000-3-3 Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low- voltage supply systems, for equipment with rated current 16 A per phase and not subject to conditional connection

• IEC 61000-4-2 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test

• IEC 61000-4-3 Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test

• IEC 61000-4-4 Electromagnetic compatibility (EMC) – Part 4-4: Testing and measurement techniques – Electrical fast transient/burst immunity test

• IEC 61000-4-5 Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement techniques - Surge immunity test

• IEC 61000-4-11 Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests

• IEC 60721-3-2 Classification of Environmental Conditions

• ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing

• ISO 21530:2004 Dentistry -- Materials used for dental equipment surfaces -- Determination of resistance to chemical disinfectants

• ISO 13485 Medical Devices –Quality Management Systems – Requirements for regulatory purposes

• ISO 14971 Risk Management

• USA 21 CFR subchapter J (Radiological Health)

• FCC part 15 & international certifications of WiFi

• Design of Lithium Ion Polymer battery package in compliance with IEC62133

• Submission of 510K

• WEEE directives (Waste Electrical and Electronic Equipment)

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