プロフィール詳細

プロジェクトを作成

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Erik M.に依頼

United States

Seasoned professional with decision-making and leadership skills to drive quality products in design and production.

プロフィール概要

10 years of Quality and Regulatory experience in the medical device industry. During my career, I have been a key player in the development and approval of several neurovascular, neuroimaging, and cardiovascular devices. My expertise includes design control, risk management, submissions, and production.

専門分野

• ★ Medical Devices
• ★ Quality Assurance & Quality Control (QA/QC)
• ☆ Biomedical Engineering
• ☆ PreMarket Approval (PMA) Applications

サービス

• Writing
• Research
• Data & AI

Writing Clinical Trial Documentation, Technical Writing

Research Fact Checking, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Data & AI Statistical Analysis

職務経験

QA/RA Manager

M4D

8月 2018 - 現在

Senior Quality Manager

MRI Interventions (ClearPoint Neuro)

8月 2017 - 8月 2018

QA/RA Manager

Marvel Medical Technologies/Neurovasc Technologies

8月 2016 - 12月 2017

Engineering Supervisor

Medtronic

9月 2012 - 8月 2016

学歴

Biomedical Engineering

Georgia Institute of Technology

8月 2008 - 8月 2012

認定資格

• 認定資格の詳細は未入力です。