
Michael Sullivan
Regulatory Post Market Surveillance Analyst

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About me
Test Engineer at Alcon | Purdue University Alumnus | Biomedical Engineering
Education

Purdue University
-Bachelor of Science - BS Biomedical EngineeringActivities and Societies: Intramural sports (Sand Volleyball, Basketball) Undergraduate Research (Department of Health and Kinesiology) Minor in ManagementGPA: 3.64

UCLA Extension
-Certificate Medical Device Engineering 4.0Classes Taken:Fundamentals of Medical Device EngineeringRegulatory Affairs for Medical Devices
Experience

Intuitive
- Feb 2024Regulatory Post Market Surveillance Analyst• Conduct thorough investigation and final classification of customer complaints regarding Intuitive products, escalating cases for additional review or reporting, and ensuring documentation completeness and consistency in accordance with 21 CFR 820• Perform event validation, review system error logs and failure analysis findings, and analyze customer testimonies to validate complaints and assess their reportability• Possess a proficient understanding of Intuitive products, known failure modes, and the complaint handling process Kevesebb megjelenítése

Hauser Shade
Apr 2019 - Jul 2021Main Shipper- Identified best shipping methods based on products ordered, customer criteria, and freight rates-Monitored transportation costs and properly filed shipping documents-Collaborated with other sections to assure products reached customer at desired time-Communicated with clients regarding order progress and completion-Packaged completed orders and assured they were properly fulfilled- Motorized automatic shades and assembled components for manual shades- Executed diverse manufacturing responsibilities encompassing all phases of shade production Kevesebb megjelenítése

Purdue University
May 2022 - Apr 2023Undergraduate ResearcherClinical Study on Local Heat Therapy’s Impact on Walking Performance of Sedentary Seniors• Participated in pilot experiments and contributed to troubleshooting and modifyingclinical trial protocol for a novel heat therapy that involved water circulating trousers• Computed calf muscle cross-sectional areas from MRI images using ITK-SNAP• Executed experimental protocol and recorded observations from subject’s performance• Presented the scientific basis and rationale for the novel water-circulating heat therapy pants used in the clinical trial at an undergraduate research exposition Kevesebb megjelenítése

Manning's Munchies
Jun 2022 - Jul 2022Vending Machine Operator- Re-stocked vending machines on a periodic and need basis- Troubleshot and repaired out of order vending machines- Adjusted vending machine prices based on products' inflation, supply, and demand- Organized, maintained, and recorded warehouse inventory

Alcon
Feb 2024 - nowTest Engineer
Licenses & Certifications
- View certificate

Biomedical Research Investigators and Key Personnel
CITI ProgramAug 2022 - View certificate

Finite Element Analysis - Milestone Workshop Certificate
Purdue UniversityJun 2023 - View certificate

CAD / 3D Printing - Milestone Workshop Certificate
Purdue UniversityDec 2022 - View certificate

EBEC: Entry-Level Programming in Python
Purdue UniversityMay 2022 - View certificate

Responsible Conduct of Research Training
CITI ProgramAug 2022
Honors & Awards
- Awarded to Michael SullivanBest Overall Senior Design Project - OPTML Lung Cooling System Weldon School of Biomedical Engineering Dec 2022 Awarded best overall senior design project for its potential impact, design rigor, and novelty. The project aimed to reduce post-graft dysfunction (PGD) incidence with a passive cooling system capable of keeping lung tissue within an optimal temperature range (7-10 C) during transport from the procurement center to the transplant center. PGD is a severe lung injury that occurs within the first 72 hours following transplant and is characterized by diffuse pulmonary edema. It is the leading cause… Show more Awarded best overall senior design project for its potential impact, design rigor, and novelty. The project aimed to reduce post-graft dysfunction (PGD) incidence with a passive cooling system capable of keeping lung tissue within an optimal temperature range (7-10 C) during transport from the procurement center to the transplant center. PGD is a severe lung injury that occurs within the first 72 hours following transplant and is characterized by diffuse pulmonary edema. It is the leading cause of early mortality for lung recipients. Show less
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