Biomedical Engineer Resume Example
A biomedical engineer resume example with 5+ years of experience in medical device development and regulatory compliance.
Daniel Kim
PROFESSIONAL SUMMARY
Innovative Biomedical Engineer with 5+ years of experience in medical device development and clinical validation. Expertise in product design, regulatory compliance, and quality management systems. Track record of successfully bringing medical devices from concept to market while ensuring FDA compliance and patient safety.
EXPERIENCE
Senior Biomedical Engineer2020 - Present
Medtronic
- •Lead engineer for development of next-generation cardiac monitoring devices
- •Manage cross-functional team of 7 engineers through design and validation phases
- •Develop and implement testing protocols ensuring compliance with FDA regulations
- •Collaborate with clinical teams to optimize device performance based on user feedback
Medical Device Engineer2018 - 2020
Boston Scientific
- •Designed and developed minimally invasive surgical instruments
- •Conducted verification and validation testing for 510(k) submissions
- •Implemented design controls and risk management processes per ISO 13485
- •Reduced product development cycle time by 30% through process improvements
Biomedical Research Engineer2016 - 2018
Mayo Clinic
- •Developed novel biomaterials for tissue engineering applications
- •Conducted preclinical studies and analyzed experimental data
- •Collaborated with physicians to identify unmet clinical needs
- •Published research findings in peer-reviewed medical journals
EDUCATION
Master of Science in Biomedical Engineering2014 - 2016
University of Minnesota
Bachelor of Science in Biomedical Engineering2010 - 2014
Johns Hopkins University
SKILLS
Medical Device Design, FDA Regulations, Quality Management Systems, Clinical Validation, Risk Management, CAD (SolidWorks), MATLAB, Product Development, Design Controls, Verification and Validation, Statistical Analysis, Technical Documentation, ISO 13485, GMP ComplianceMore Resume Examples in Engineering
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