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Electrical Engineer Project Manager

Location:
Wayland, MA
Posted:
July 03, 2023

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Resume:

LEONID PESOK

*** ******** ***, *** ***

WATERTOWN, MA 02472

(617) 775- 8740 cell

adx2lu@r.postjobfree.com

Strong background in analog/digital design engineering & medical hardware. Extensive experience in Analog devices; Motion Control; Power management; Electrosurgical devices; CE marking; FDA, FMEA; IEC60601, OrCAD and Altium capture.

2022 – current Senior Electrical Engineer, Gener8, Woburn MA Medical Device schematic development, BOM, prototyping, testing. 2019 – 2022 Principal Electrical Engineer, Epam Systems, Boston MA Hardware development for the large IVD delivery system. International team. EMC/EMI solutions and testing. Power distribution design for entire unit. Safety requirements implementation based on IEC 61000.

2016 – 2019 Senior Electrical Engineer, Canon USA, Cambridge MA Design, development, all boards schematic design, testing two generations of Optical Computer Tomography system for blood vessels catheterization. CF level device development complied with IEC 60601. Successful imaging and animal trials 2015 – 2016 Senior Electrical Engineer, Protom International, Inc., Wakefield, Design, development, integration in Cancer Proton Therapy center, based on the Synchrotron accelerator.

2013 – 2015 Senior Electrical Engineer, Daktari Diagnostics, Inc., Cambridge Hardware development of the precise Blood Conductivity Measuring Device for the HIV detection. Device optimization, adaptation to the critical environment condition. Full scale CE marking testing preparation, supporting and passing in Europe. 2010 – 2013 Senior Electrical Engineer, Protom International, Inc., Wakefield Design, development, integration of Cancer Proton Therapy center, based on the Synchrotron accelerator.

System architecture, overall schematics, EMF compensation. Overall cabling/wiring/cabinets layout.

2000 A dynamic power supply (3000A/S ramping, 55kW discharge) and switching development.

Working prototype upgrade for the FDA approval, EMC/EMI testing. Verification and Validation processes.

2008 – 2010 Lead Project Engineer, Enginivity LLC, Lexington, MA Full body and blood warmers controllers and driver’s development. PTC ink implementation for the new heaters.

Full body and blood warmers clinical trial.

2004 – 2008 Principal Electrical Engineer, Ximedica LLC, Providence, RI Lead circuit design and development of the medical projects: High voltage, high frequency Alpha prototype of the Pulsed Electron Avalanche Knife development for the common surgery.

Microcontroller embedded Oxygen Blender

EEG based Smart Sleep alarm clock development

Responsible for ЕN60601-1-2 implementation in new medical devices design and development.

2002 – 2004 Project Manager, TUV America, Medical Service, Danvers, MA Active Medical Devices Auditing and Testing.

Medical Devices Directive Certification.

ISO 13485:2003, ISO 9001:2000 Lead Auditor Certification. Verification and Validation processes study.

TUV Auditor Authorization.

EN60601-1 certified.

1998 – 2002 Senior Electrical Engineer, Product Genesis, Cambridge, MA Lead circuit design and development of the medical projects: High voltage, high frequency prototype of the Pulsed Electron Avalanche Knife Development of the new cardiac high-pressure Contrast Injection System. Multi channels precise temperature and pressure measurement. Valves control. Overall electrical design for medical application with UPS power supply. Circuitry, PCB and interface development for Optical Biopsy System Alfa prototype. Designed, developed and implemented computer-aided signal processing board for precise measurement of the light spectrum (from UV to IR). Low current consumption, portable Radioactivity Dosimeter design and development 1996 – 1998 Electrical Engineer, Vista Medical Technologies, Westborough, MA. Engineering support for development and manufacturing of 3-D image TV systems Conducted EMC/EMI/CE testing for number of Stereo Cameras systems. EMC/EMI consulting for PCBs and systems design.

Designed boards and overall schematics for the Aesculap Single Chip Camera and 2- D Cardio Controller.

EDUCATION: MSEE, majoring in electronics.

University of Electrical Engineering, LETI, St. Petersburg, Russia. CERTIFICATES: ELECTRICAL SAFETY OF MEDICAL DEVICES IEC/EN60601-1 ISO13485/IS09001

ISO/EN 13485 NOTIFIED BODY TRAINING

ACTIVE MEDICAL DEVICE AUDITOR

AWARDS: MDEA 2009, Pulsar generator surgical cutting and coagulation device, manufactured by Peak Surgical Inc.



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