Biomedical Engineering Student - Quality & Regulatory Focus

Aidan Hughes

*** ******** *****, *********, ** • 513-***-**** • *******@****.**.***

WORK EXPERIENCE

Ethicon 01/2023 - 04/2023

Quality Engineering Co-Op Cincinnati, OH

• Analyzed, developed, and implemented FMEAs in alignment with ISO 14971 risk management standards

• Spearheaded and project managed a device lifecycle study within design control framework

• Led cross-departmental initiative to strengthen risk management strategies, improving product safety and regulatory compliance

Medpace 05/2022 - 08/2022

Medical and Regulatory Affairs Co-Op Cincinnati, OH

• Conducted comprehensive background research on potential new drugs, enhancing the pipeline for future projects within 3 months.

• Conducted a comparative analysis of the competitive landscape, identifying key market trends that informed strategic decisions.

• Assisted in patient data cleaning and merging

Ace Medical 08/2021 - 12/2021

Biomedical Engineering Co-Op Cincinnati, OH

• Heavily supported ISO 13485 certification through QMS development and audit preparation

• Helped Ace Medical obtain ISO 13485 certification

• Implemented and improved traceability systems, strengthening compliance and documentation integrity

• Contributed to quality system improvements and regulatory readiness for product commercialization Various Companies 01/2020 - Present

Vendor Nationwide

• Ranked in the top 5% of vendors across 20+ national events and venues

• Generated $5K–$10K+ in sales per shift in high-volume, fast-paced environments

• Selected for premier events including the Super Bowl based on performance and reliability

• Built strong customer relationships, consistently driving repeat business and upselling

• Managed high-volume cash and digital transactions with zero discrepancies under pressure EDUCATION

Bachelor of Science: Biomedical Engineering

University of Cincinnati • GPA: 3.3 Cincinnati, OH • 05/2024 Honors Diploma

Lakota West High School • GPA: 3.3 West Chester, OH • 05/2019 AWARDS & SCHOLARSHIPS

Community Changer Award 01/2019

Boys and Girls Club

Dean’s List

University of Cincinnati College of Engineering and Applied Sciences Associate of the Year

Mike’s Carwash

PROJECTS

Engineering Design Thinking Project 08/2019 - 05/2020 UC Project

• Performed role of a team leader responsible for designing and testing robot for engineering design semester project

• Developed Carbon Sequestration Methods

VOLUNTEERING & LEADERSHIP

Bearcat Motorsport 01/2019 - Present

Member

Conduct maintenance and check race cars for proper performance and safety before races Boys and Girls Club

Tutor and Homework Helper

Tutored and helped with homework activities

01/2017 - 01/2019

Boys and Girls Club

Mentor

01/2017 - 01/2019

Mentored children on importance of education and respect for others Boys and Girls Club

Power Hour Tutor Volunteer and Mentor

01/2017 - 01/2019

SKILLS

FMEA, CAPA, ISO 13485, ISO 14971 Risk Management, Root Cause Analysis, MATLAB, Python, R Programming, SOLIDWORKS, Microsoft Excel, LabView, Technical Writing, Data Analysis

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