Mohammad Golshani Pour

**,**** *****, ** *******, Isfahan

Email:ado3fa@r.postjobfree.com Phone : +989********* KEY COMPETENCIES :

Medical Device Quality Systems Designer

Medical Device Validation and Verification Engineer Expert on Medical Radiation Equipment (Diagnostic & Therapy) Expert on Cardiac & respiration (Defibrillators, Ventilators, Patient Monitoring system …) Expert on Microsoft office,

PROFESSIONAL EXPERIENCE

Behyar Sanat Sepahan: Knowledge Base Medical Device Manufacturer

(2013- 2021 Esfahan -Iran)

Responsibilities:

Quality Engineer in Radiology & Radiotherapy R&D Department Head of clinical investigation, risk assessment & harmonized standard evaluation team for CE marking

Played a key role as a consultant for designing and manufacturing diagnostic and therapy medical LINAC (Linear Accelerator 6 MeV) X-ray equipment and industrial investigation systems as a member of R&D team

Designed and executed QA & QC procedures for manufacturing of Medical LINAC (Linear Accelerator 6 MeV) and diagnostic radiology based on medical device directive MDD"93/42/EEC" Class IIa, IIb

Member of risk assessment team for diagnostic radiology & radiotherapy machine (Linear Accelerator 6 MeV) & dosimetry equipment based on ISO 14971:2019 (FMEA) Implemented of ISO 13485 (manufacturing procedures and final quality control) for diagnostic radiology and radiotherapy machine (Linear Accelerator) Implemented of ISO 9001 for Industrial X-ray Investigation Systems (Cargo Scanner, luggage and Body Scanner)

Completely fluent with the following standards:

IEC 60601_1 Basic safety of medical device

IEC61010_1 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements

IEC62304:2006 Medical device Software /software life cycle processes IEC60976 Medical electron accelerators - Functional performance characteristics IEC60977 Guidelines for functional performance characteristics IEC60601_2_1 Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV IEC61217 Radiotherapy equipment - Coordinates, movements and scales IEC 62083 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems

IEC60731 Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy

IEC 60601_1_3 Basic safety of medical radiation device Radiation protection in diagnostic X-ray equipment

IEC60601_2_54 Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

IEC 62523 Radiation protection instrumentation - Cargo/vehicle radiographic inspection system

IEC61010_2_91 Particular requirements for cabinet X-ray systems IEC60601_1_8 Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 60601_1_2 Medical device electromagnetic compatibility Familiar with application of usability engineering to medical devices based on IEC 62366_1 Familiar with requement of ISO17025

EDUCATION :

Bachelor of Bio Medical Engineering /Bio Electric Sahand University of Technology (2009- 2013)

Studying Master of /medical Radiation/ Azad university(2020 until now CERTIFICATES :

Medical Device Directive MDD"93/42/EEC" Class IIa, IIb From (QIWA) 2018 Radiation protection From (Parto Azma) 2017

ISO 13485 From (BRS) 2014

ISO 9001 From(BRS) 2014

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