Summary
Work History
Education
Skills
Languages
Timeline
Generic
Fahimeh Asadian

Fahimeh Asadian

Cologne

Summary

Accomplished Executive Expert, Technical supervisor, project planner in medical device and equipment field with more than 13 years of experience in IRAN, Clear understanding of MDD, MDR, GMP, ISO 13485, Quality Management, Calibration, Clinical Trials and medical device recall and report process, extensive knowledge of Iran's medical device market. Leveraging strong team management and development to drive forward progress. Highly organized, detail-oriented leader skilled in directing high-performing teams of experts and inspectors to develop solutions and solve operational and technical problems. Success implementing systems across multiple Operations like determining quantity and quality of devices needed for orthopedic, surgery etc. Operations and procedures with superior organizational and communication skills. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills. Motivated to learn, grow and excel in medical device industry from supply to regulation. Ready to apply experience and skills to challenging new role.

Work History

Deputy Executive Director

Shiraz University of Medical Sciences
Shiraz
05.2019 - 12.2021
  • Developed thought leadership around specific topics and emerging practice areas.
  • Demonstrated experience strategizing plans and improving agency position in multiple areas.
  • Delivered superior results, commanded respect and assumed leadership roles to serve agency goals.
  • Provided exceptional counseling, case management, education and job training to medical engineers of 45 hospitals and more than 60 local companies.
  • Recruited 10 new engineers by qualifying them and training them for auditing with promotional materials and on-site experiments.

Medical Device Consultant

Dena Medical Group
Shiraz
01.2016 - 10.2021
  • Identified prospect needs in general surgery (Staplers, Cartridges, Sutures, Mesh, etc.) and home-care equipment and developed appropriate responses along with information on suitable products and after sales services specially training and calibration
  • Used consultative sales approach to understand and meet customer needs.
  • Maintained thorough and current knowledge of medical device products, competitive offerings and market developments to capitalize on growth and expansion opportunities
  • Initiated effective purchase and sales techniques and drove product sales to over 20% annually.

Technical Consultant

Toranj Pooshesh Co
Shiraz
09.2018 - 09.2021
  • Inspected production line of hospital clothes
  • Formulated plans for improving procedures, training and processes resulted in more than 15% in production after 6 month.
  • Resolved malfunctions with systems and programs through troubleshooting.
  • Produced documentation on latest updates as well as reports detailing findings and recommendations.
  • Consulted to address system issues to enhance usability and improve functionality resulted in 20% increase in revenue
  • Evaluated training procedures for 10 employees, designing improvements and alterations based on statistical feedback and observation.

Senior Medical Engineer

Shiraz University of Medical Sciences
Shiraz
05.2014 - 03.2019
  • • In-charge for medical device recalls and reports, MDD, MDR, GMP inspections
    • Authorized 25 Medical Device Production licenses, approved by Iran's General Directorate of Medical Equipment Supervision and Evaluation
    • Managed 13 projects of clinical testing new medical devices waiting for approval or devices with new brands (Absorbent dressing, hydrocephalus shunt, N95 Mask, Auto analyzer, etc.)
    • Senior negotiator in purchasing medical devices for more than 7 years
    • Supervised Quality management inspections; assessing process of maintenance/ calibration of medical equipment in hospitals,
    • Quality auditory of 12 production lines as certified auditor
    • Directed scientific committees for writing 3 guidelines of rational prescribing for cardiovascular and vascular stents, IOL lens, orthopedic cement based on necessities of medical centers and their financial resources.
    • Support regulatory affair departments of medical devices’ manufacturers and companies
    • Trained and managed more than 60 junior engineers and surveyors.
    • Identified needed parts to keep equipment in top operating condition.
    • Managed more than 155 inspection and evaluation project documents, 18 recall cases and 55 compliance cases.

Executive Director of Orthopedic Implants Supply

Shiraz University of Medical Sciences
Shiraz
05.2012 - 12.2017
  • Executive Director of committee of supplying orthopedic and spinal implants
  • Worked closely with 10 orthopedic surgeons (knee surgeon, spine surgeon, general orthopedist), board of orthopedics in Shiraz University of medical Sciences to strategically affect operational direction
  • Aligned department vision, goals and objectives with financial and moral strategies to achieve consistently high results
  • Coordinating writing of 5 guidelines to grant proper applications and checked information for accuracy prior to purchase implants and use.
  • Recruited at least 25 new members in operating rooms of hospitals to conduct guidelines.
  • Prioritized and allocated valuable resources.
  • Managed over 45 hospitals and save 25% in budgeting after first year of implementing guidelines.
  • Provided exceptional counseling, case management, education and guideline training to operating room staffs.
  • Interviewed, supervised and motivated more than 25 staff members to achieve optimal result.
  • Coordinated and implemented effective training for over 25 professionals to improve brand and device type selection processes.

Health Economics and HTA Associate

Shiraz University of Medical Sciences
Shiraz
01.2013 - 12.2015
  • Coordinated statistical data analysis about high-tech equipment like MRI machine, HIFU, Gamma Knife, etc, design and information flow.
  • Participated in requirements meetings and data mapping sessions to understand business needs.
  • Compiled, evaluated and reviewed engineered, financial and clinical data for internal system.
  • Monitored hospitals medical device consumption to keep stock levels and financial allocation optimized.

Medical Device Expert

Shiraz University of Medical Sciences
Shiraz
10.2008 - 04.2014
  • • Formulated and Executed plans for improving procedures, training, and processes.
    • Supervised Calibration, maintenance, and operated equipment in 45 public hospitals for maximum performance during annual visits.
    • Coordinated four committees and prepare lists of principle devices and equipment needed for ORs, ICU, CCU, Laboratory wards of hospitals which resulted in optimal consumption
    • Developed 15 flowcharts and diagrams to describe and lay out logical operational steps.
    • Delivered in-depth training, imparting knowledge of best practices of MDD, MDR, GMP, medical device recalls and reports through continued education and training more than 300 staff for 8 years
    • Provided high-level technical expertise to projects in quality management and regulatory of more than 20 producers in Fars Province
    • Conducted 23 clinical trials to test performance, durability, and cost-effectiveness of medical devices and machines like coagulometer, cell counter, arthroscope, etc. and reporting results to manufacturers and top managers.
    • Conducted Post Market Surveillance systems comprised of IV cannula, dhs, dcs, spinal implants, etc. producing reports collected from laboratories to Iran’s Ministry of Health in over 5 years
    • Improved consumption system by adding new guidelines resulted in about 15%
    • Evaluated training procedures for more than 120 auditors and medical engineers at Shiraz University of Medical Sciences over 6 years

Education

Master of Science - Industrial Engineering and International Management

Hochschule Fresenius
Cologne, Germany
02.2024

Master’s degree - Nuclear Engineering

Shiraz University
Shiraz, Iran
02.2010

Bachelor’s degree of - Electronic Engineering

Shiraz University of Technology
Shiraz, Iran
07.2006

Associate degree of Electronics - Electronic Engineering

School of Engineering, Shiraz University
Shiraz, Iran
07.2004

Skills

  • Business English proficiency
  • Project management, MDR and GMP experienced
  • Technical negotiation for supply Experienced in middle east and in particular, Iran’s medical device market
  • Change and Growth Management
  • Strategic Planning
  • Leadership and People Development
  • Industry Expertise
  • Report Compilation
  • Performance Optimization Strategies
  • Corrective Actions
  • Regulatory and Statutory Compliance
  • Workforce Planning
  • Operational Efficiency
  • Continuous Quality Improvement (CQI)
  • Adaptable and Flexible
  • Multitasking Abilities

Languages

Persian
Bilingual or Proficient (C2)
English
Advanced (C1)
German
Intermediate (B1)

Timeline

Deputy Executive Director

Shiraz University of Medical Sciences
05.2019 - 12.2021

Technical Consultant

Toranj Pooshesh Co
09.2018 - 09.2021

Medical Device Consultant

Dena Medical Group
01.2016 - 10.2021

Senior Medical Engineer

Shiraz University of Medical Sciences
05.2014 - 03.2019

Health Economics and HTA Associate

Shiraz University of Medical Sciences
01.2013 - 12.2015

Executive Director of Orthopedic Implants Supply

Shiraz University of Medical Sciences
05.2012 - 12.2017

Medical Device Expert

Shiraz University of Medical Sciences
10.2008 - 04.2014

Master of Science - Industrial Engineering and International Management

Hochschule Fresenius

Master’s degree - Nuclear Engineering

Shiraz University

Bachelor’s degree of - Electronic Engineering

Shiraz University of Technology

Associate degree of Electronics - Electronic Engineering

School of Engineering, Shiraz University

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Fahimeh Asadian