Ethan Caldwell Email & Phone Number

Mishawaka, Indiana, United States

Created and activated HMI screens using TIA portal directly on the manufacturing line to visually monitor sensor status in real-time, enhancing operator safety by eliminating the need for emergency door access during troubleshooting and reducing downtime through quicker issue identification. Finalized validation documentation, developed a sampling plan and ran experimental testing, and performed installation procedures for new dispense pumps to reduce downtime by 100 hours per year. Developed and launched a centralized SharePoint website to streamline access to crucial documentation, collected in-person videos of production line issues, and leveraged AI to create protocols for each to address current challenges of document retrieval and reduce legacy knowledge. Reverse-engineered a wire stripper to design a tool to transversely split reagent strips to streamline reagent spool exchanges, reducing downtime for line closure and cutting waste of 35 parts per change.

Led a team in the completion of a stent testing project including device production, creation of manufacturing instructions and testing protocol, and testing of products to confirm a high standard. Updated testing documents and supplier certifications in order to correct TUV regulation deficiencies. Created and implemented a reproductive device production change plan that decreased product nonconformance rate by creating a new quality control inspection. FConducted design and risk updates to publish documents for regulatory body verification.

Led a remediation project by supporting the authorship of the published Change Order lifecycle and preparing documents to be published by filling in documentation and testing gaps. Completed three types of risk management documents by evaluating medical device failures, analyzing direct harms to the patient, and ensuring patient risk is minimized. Revised labeling and Instructions For Use (IFU) documents to ensure that they were updated to the new European Union Medical Device Registry standards

Fishers, Indiana, United States

Collaborated with biomedical product representatives, engineers, and surgeons of orthopedic, neurosurgical, and robotic subspecialities in a hospital environment. Assisted in the development of a personalized surgical plan, guided the utilization of neurosurgical software and hardware intraoperatively, and participated in the debriefing of product effectiveness. Gained insight into biomedical product design and real-world experience, allowing for a greater understanding of product advantages and the potential for future improvements

Fishers, Indiana, United States

Cooperated with team members in order to provide the highest standard of efficient and effective service possible. Collaborated with management to ensure the attainment of product and financial goals were being met.

Fishers, Indiana, United States

Interacted with club members on a daily basis to ensure the highest level of customer satisfaction. Directly responsible for the maintenance and beautification of course grounds

Bachelor Of Science - Bs, Biomedical Engineering

Activities and Societies: Engineering Projects in Community Service, Adapted Toys for Children, A Paws for Cause, American Society.

Minor In Spanish

High School Diploma, General Studies

Activities and Societies: Varsity Soccer Captain, National Honors Society, Model UN Delegate, Ski Club