Bayt.com
سمير الحمدان, Senior Biomedical Engineer

سمير الحمدان

Senior Biomedical Engineer

Saudi Food & Drug Authority SFDA

البلد
المملكة العربية السعودية - الرياض
التعليم
ماجستير, English Language during period
الخبرات
15 years, 0 أشهر

مشاركة سيرتي الذاتية

حظر المستخدم


الخبرة العملية

مجموع سنوات الخبرة :15 years, 0 أشهر

Senior Biomedical Engineer في Saudi Food & Drug Authority SFDA
  • المملكة العربية السعودية - الرياض
  • أشغل هذه الوظيفة منذ مايو 2011

Senior Biomedical Engineer, working in quality and risk dept.

Basic knowledge about standards and government regulations applicable to medical devices outside the Middle East e.g. ISO 13485, 21 CFR 820 QSR,

Experience in related field e.g. Regulatory Affairs, Quality Assurance,

project engineer في EL SIEF DEVELOPMENT COMPANY
  • المملكة العربية السعودية - الرياض
  • مارس 2006 إلى يناير 2008

Project engineer : my responsibilities include:

• Technical and Financial study of the Tender.
• Negotiation with suppliers for better pricing and terms and conditions.
• Supervising Delivery and Installation of equipment at site.
• Leadership skills
• Ensuring handover of projects before deadline
• Tracking of documentation to ensure collection of invoices from customers.
• Installation of ultrasound machines at different primary healthcare centers all over Saudi Arabia.
• End-user training on ultrasound machines
• Visit to different clients and follow up with them on various issues
• Participating in biomedical maintenance tender, which include arranging of sub-contract's quotation, segregation of specialized equipment and preparation of worksheet for which sub-contract agreement required.

الخلفية التعليمية

ماجستير, English Language during period
  • في La Trobe university
  • ديسمبر 2010

• Certificate in English Language during period (February 2008 till December 2008) from La Trobe language centre Melbourne -Australia.

Specialties & Skills

Biomedical Engineering
+Endorse 0
Spec Writing
+Endorse 0
Biomedical Instrumentation
+Endorse 0
Regulatory Affairs
+Endorse 0
Instrumentation
+Endorse 0
C language
+Endorse 0
MAT LAB
+Endorse 0
Medical Devices Standards
+Endorse 0
Medical Devices Regulations
+Endorse 0
مواصفات الأجهزة الطبية
+Endorse 0

اللغات

العربية
متمرّس
الانجليزية
متمرّس

العضويات

ISO
  • • Secretary of National mirror of committee of ISO-TC 121 Anaesthetic and respiratory equipment, sin
  • January 2015
GSO
  • • A member of the gulf standards technical committee GSO/TC 11 “Medical Devices and Supplies” since
  • January 2015
CBAHI
  •  Member of Standard Applicability Taskforce Group, Saudi central board for accreditation of healthc
  • March 2018
ISO
  •  A member of ISO-TC 121 Anaesthetic and respiratory equipment
  • February 2014

التدريب و الشهادات

Risk Analysis , Assessment , and Management organized by GSO (تدريب)
معهد التدريب:
GSO
تاريخ الدورة:
January 2013
المدة:
24 ساعة
Risk Analysis, Assessment,and Management (الشهادة)
تاريخ الدورة:
January 2013
صالحة لغاية:
January 2013
3- Understanding an ISO 13485 Quality Management System (الشهادة)
تاريخ الدورة:
July 2012
صالحة لغاية:
July 2012
Certificate in English Language during period (الشهادة)
تاريخ الدورة:
February 2008
صالحة لغاية:
December 2008
Understanding FDA’s Medical Device QSR and QSIT (الشهادة)
تاريخ الدورة:
March 2012
صالحة لغاية:
March 2012
Simplification of work processes and procedures (الشهادة)
تاريخ الدورة:
July 2011
صالحة لغاية:
July 2011