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Bruce T.に依頼

Canada

Biomedical engineering graduate with 3.5+ years expertise in medical device development & quality/regulatory compliance

プロフィール概要

I have a Bachelor's in Biomedical Engineering from Toronto Metropolitan University (formerly Ryerson) and a Master's of Biomedical Engineering from University of Toronto. Throughout my undergraduate and graduate studies, I completed coursework based in biological, electrical, computer and mechanical engineering. In my Master's degree, I focused on medical device design, prototyping and regulatory compliance. Upon completing my Master's degree, I worked as a consultant engineer at Springborne Life Sciences, an engineering consulting firm. In my role, I supported our clients by leading regulatory and quality compliance efforts (ensuring adherence to FDA Quality System Regulations and ISO 13485, ISO 14971, and ISO 9001 standards), overseeing design controls, maintaining the design history file (e.g., engineering drawings, specifications, and technical documentation), and organizing research data. Additionally, I helped develop quality compliance software for Springborne Life Sciences' clients. Accordingly, I have 3.5+ years of experience and a strong skill set in biomedical product development and quality/regulatory compliance, which makes me a valuable asset to any team in the biomedical field. Please feel free to message me, or contact me at xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx, to discuss how I can best contribute to your project.

専門分野

• ★ Medical Device Design
• ★ Medical Device Prototyping
• ★ Medical Device Regulatory Consulting
• ☆ Biomedical Engineering
• ☆ Engineering Design
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Biocompatibility Testing
• ☆ Medical Device Manufacturing
• ☆ Medical Device Safety Testing
• ☆ Medical Device Validation
• ☆ Medical Implants
• ☆ Wearable Technology
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance

サービス

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

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing

Research Market Research, User Research, Feasibility Study, Technology Scouting, Gap Analysis, Scientific and Technical Research, Systematic Literature Review

Consulting Go-to-Market Strategy Consulting, Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis, Data Visualization, Data Processing

Product Development Stability/Shelf Life Testing, Product Evaluation, Product Validation, Quality Assurance & Control (QA/QC), Product Compliance , Concept Development, Prototyping, Reverse Engineering

職務経験

Engineer Consultant/Research Associate

Springborne Life Sciences

12月 2020 - 11月 2024

学歴

Master of Engineering

University of Toronto

9月 2018 - 11月 2019

Bachelor of Engineering (B. Eng.)

Ryerson Polytechnic University - Canada

9月 2013 - 6月 2018

認定資格

• Six Sigma Black Belt Certification

  LinkedIn

  11月 2025 - 現在