Profile Details

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Hire Ayoub B.

France

USD 30 /hr

Biomedical Engineer | Freelancer in Qualification and Validation, Medical Device and Continuous Optimization

Profile Summary

I am a trilingual Biomedical Engineer (French/English/Arabic) with dual academic training from UTC Compiègne (France) and ENSAM Rabat (Morocco), and over one year of experience. I specialize in qualification and validation, medical device compliance, and continuous process optimization. I offer freelance services including: - Equipment qualification and validation (IQ, OQ, PQ) in the medical device and pharmaceutical industries - Continuous improvement and lean-based process optimization (DMAIC methodology) - Regulatory compliance with ISO 13485, MDR2017:745, CFR Part 11, and GAMP 5 - Maintenance strategy development and medical equipment lifecycle management - Support in drafting technical documentation and preparation for audits in medtech and pharma sectors My background combines hands-on technical experience in hospital and manufacturing environments with strong knowledge of quality assurance systems. I help clients ensure regulatory compliance, streamline operations, and bring safer, high-quality healthcare products to market. Special offer for my future clients on Kolabtree: Enjoy 2 free consultation hours on your first project!

Subject Matter Expertise

• ★ ISO 13485
• ★ Technical & Scientific Writing
• ★ SOP & Protocol Writing
• ☆ Biological Engineering
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Manufacturing
• ☆ Medical Device Safety Testing
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Medical Implants
• ☆ Wearable Technology
• ☆ Medical Device Prototyping
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ In vitro Diagnostic Design
• ☆ Point-of-Care Devices
• ☆ Medical Imaging/Radiology
• ☆ Interventional Radiology
• ☆ Nuclear Medicine
• ☆ Human Biology
• ☆ Magnetic Resonance Imaging (MRI)
• ☆ Medical X-Ray
• ☆ Endoscopy
• ☆ Electrocardiogram (ECG)
• ☆ Echocardiography
• ☆ Computed Tomography (CT)
• ☆ Mammography
• ☆ Positron Emission Tomography (PET)
• ☆ Ultrasound
• ☆ Image-Guided Biopsy
• ☆ DEXA Scan
• ☆ Fluoroscopy
• ☆ Diagnostic Radiology
• ☆ Oral & Maxillofacial Radiology
• ☆ Medical Sciences
• ☆ Pharmaceutical Management
• ☆ Medical Equipment & Supplies
• ☆ Cardiothoracic Radiology
• ☆ Muscoskeletal Radiology
• ☆ Neuroradiology
• ☆ Nuclear Radiology
• ☆ Pediatric Radiology
• ☆ Continuing Medical Education (CME) Training
• ☆ Medical Writing
• ☆ Medical Content Writing
• ☆ Healthcare Communications
• ☆ Patient Education Materials
• ☆ Research Summaries & Abstracts
• ☆ Medical Copywriting
• ☆ Journal Selection
• ☆ Manuscript & Journal Article Writing
• ☆ Instructional Materials
• ☆ Release Notes
• ☆ Experimental Protocols
• ☆ White Papers
• ☆ Spec Sheets
• ☆ Case Studies
• ☆ Textbook Content Writing
• ☆ Science Communication

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Medical Writing, Non-Medical Regulatory Writing, Technical Writing

Research User Research, Scientific and Technical Research

Consulting Healthcare Consulting, Operations Consulting, Regulatory Consulting, Manufacturing Consulting

Data & AI Image Processing, Image Analysis

Product Development Stability/Shelf Life Testing, Quality Assurance & Control (QA/QC), Device Fabrication

Work Experience

Engineer in Qualification, Computerized System Validation (CSV), and Continuous Improvement

Getinge - InterVascular | La Ciotat, FRANCE

September 2024 - February 2025

Assistant engineer to Hospital Biomedical Engineer

IBN SINA University Hospital Center | Rabat, MOROCCO

July 2022 - September 2022

Assistant engineer to Hospital Biomedical Engineer

Hassan I Provincial Hospital Center | Tiznit, MOROCCO

July 2021 - August 2021

Education

Dual Biomedical Engineering Degree

UTC (Université de Technologie de Compiègne),

September 2022 - February 2025

Biomedical Engineering Degree in Hospital Instrumentation

ENSAMR (École Nationale Supérieure d'Arts et Métiers de Rabat), Morocco

September 2020 - June 2022

Industrial Sciences and Technologies

Preparatory Classes for Engineering Schools (CPGE Agadir), Morocco

September 2018 - June 2020

Certifications

• Six Sigma Green Belt Certification

  LinkedIn Learning

  https://www.linkedin.com/learning/certificates/20a7a2cbfb48b99a5abfa28a87f30ea270a79eccc4974b915cfc3fcdc7b2e471?lipi=urn:li:page:d_flagship3_profile_view_base_certifications_details;vP2GTUHpTdqpeGDGYKVdkg==

  April 2025 - Present

• Six Sigma Black Belt Certification

  LinkedIn Learning

  https://www.linkedin.com/learning/certificates/194d2986c2a23b3363f7c5eafefc174948dade01e366527740553afceb3cc296?lipi=urn:li:page:d_flagship3_profile_view_base_certifications_details;vP2GTUHpTdqpeGDGYKVdkg==

  April 2025 - Present

• The Foundations of Operational Excellence

  LinkedIn Learning

  https://www.linkedin.com/learning/certificates/c1896b30be778e63f9784f407d71593e150dd6d708b1bd19622de2ba0b6f0a60?lipi=urn:li:page:d_flagship3_profile_view_base_certifications_details;vP2GTUHpTdqpeGDGYKVdkg==

  April 2025 - Present

• Introduction to Minitab 17

  LinkedIn Learning

  https://www.linkedin.com/learning/certificates/8ab9bd1db6b4240f7901c3ae80fa6dfbe21e7c1946fb21ad41948acd2b673824?lipi=urn:li:page:d_flagship3_profile_view_base_certifications_details;vP2GTUHpTdqpeGDGYKVdkg==

  April 2025 - Present

• Les fondements des statistiques

  LinkedIn Learning

  https://www.linkedin.com/learning/certificates/d1956acba8eb9f7ecd5362beba5a271507902872240f661dad82c09ee6d6f797?lipi=urn:li:page:d_flagship3_profile_view_base_certifications_details;vP2GTUHpTdqpeGDGYKVdkg==

  April 2025 - Present

• Essentials of European Medical Device Regulations (EU MDR2017:745)

  Alison

  https://alison.com/certification/check/1a1c411b2e

  March 2025 - Present

• Lean Six Sigma White Belt Certification

  The Council for Six Sigma Certification (CSSC)

  https://drive.google.com/file/d/1XistnaLvZR0ncXkfdO9h9NZR07-uev4a/view?usp=sharing

  March 2025 - Present

• ISO13485:2016 - Quality Management Systems for Medical Devices

  Alison

  https://alison.com/certification/check/17a4bb05f2

  March 2025 - Present

• 21 CFR Part 820 - Fundamentals of Quality System Regulation (QSR)

  Alison

  https://alison.com/certification/check/24880e25f6

  March 2025 - Present

• ISO9001:2015 Quality Management System Foundations

  The Knights of Safety

  https://academy.theknightsofsafety.com/certificates/siqkk0ehv8

  March 2025 - Present

• Deep Learning Fundamentals with Keras

  IBM

  https://courses.edx.org/certificates/79a3036a3cde40e28630bc3a57aedeac

  January 2025 - Present

• Introduction to Machine Learning in Production

  deeplearning.ai

  https://coursera.org/share/cede92d4fa88699ef75fc0e8d2d18909

  February 2024 - Present

• Machine Learning with Python: A Practical Introduction

  IBM

  https://courses.edx.org/certificates/be919709df32493bb23e4511ee366e6d

  August 2023 - Present

• Cisco Certified Network Associate (CCNA)

  Cisco Networking Academy

  https://www.credly.com/badges/485d2c55-2652-42b1-af31-26ca083ec514

  April 2022 - Present

• Professional Certificate in C Programming with Linux

  edX

  https://credentials.edx.org/credentials/cc0923720e184ad69dc3b9c708158efa/

  February 2022 - Present