Electrical Engineer Senior

LEONID PESOK

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

WATERTOWN, MA 02472

(617) 775- 8740 cell

******@*****.***

Medical device product measurement. Strong background in medical hardware engineering. Experience in Analog devices; Motion Control; Power management, Electrosurgical devices, CE marking, FDA, ISO 14971; IEC60601, IEC13485, OrCAD, and Altium capture.

2023 – 2025 Senior Compliance Engineer, IPG Medical, Marlboro MA

Medical lasers safety, EMC/EMI compatibility testing and class II certification in Intertek.

2019 – 2023 Principal Electrical Engineer, Epam Systems, Boston MA

Hardware development for the IVD delivery system. International team. EMC/EMI solutions and testing. Power distribution design for the entire unit. Safety requirements implementation based on IEC 61000.

2016 – 2019 Senior Electrical Engineer, Canon USA, Cambridge MA

Design, development, all boards schematic design, evaluating two generations of Optical Computer Tomography systems for blood vessel catheterization. CF-level device development complied with IEC 60601. Successful imaging and animal trials

2013 – 2016 Senior Electrical Engineer, Daktari Diagnostics, Inc., Cambridge

Hardware development of the precise Blood Conductivity Measuring Device for HIV detection. Device adaptation to critical environment conditions.

Full-scale CE marking testing preparation, supporting, and passing in Europe.

2010 – 2013 Senior Electrical Engineer, Protom International, Inc., Wakefield

Based on the Synchrotron accelerator, design, development, and integration of Cancer Proton Therapy center.

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 and 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 surgery.

Microcontroller-embedded Oxygen Blender

EEG-based Smart Sleep alarm clock development.

Responsible for ЕN60601-1-2 implementation in new medical device 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.

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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