Profile Details

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USD 120 /hr

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Hire Erik M.

United States

USD 120 /hr

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

Profile Summary

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.

Subject Matter Expertise

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

Services

• 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

Work Experience

QA/RA Manager

M4D

August 2018 - Present

Senior Quality Manager

MRI Interventions (ClearPoint Neuro)

August 2017 - August 2018

QA/RA Manager

Marvel Medical Technologies/Neurovasc Technologies

August 2016 - December 2017

Engineering Supervisor

Medtronic

September 2012 - August 2016

Education

Biomedical Engineering

Georgia Institute of Technology

August 2008 - August 2012

Certifications

• Certification details not provided.