Tony Espinosa
Completed a Bachelor of Science, in Mechanical Engineering. Pursuing a Masters in Business Administration.
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Innovating and Designing Customer-Centric Engineering Solutions
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View current and completed engineering projects here.
Continue below for resume and contact information.
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PROFESSIONAL EXPERIENCE
Chief Catheter Engineer and Quality Control Manager
Vascular BioSciences
Goleta, CA
Head of the engineering team responsible for manufacturing, as well as product design of the endoarterial biopsy catheter. Managed all quality control documents associated with the production, storage, and handling of the catheters using ISO 13485 standards. These documents included the Design History File, Device Master Record, Cleanroom Procedures, Manufacturing Instructions, and more.
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Managed a team of five engineering employees and interns at VBS, and oversaw all engineering projects and quality control procedures.
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Responsible for the production and development of the endoarterial biopsy catheter.
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Finalized the majority of the quality control system at VBS, including standard operating procedures, corrective and preventive action, and risk management.
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Ensured the quality of the produced endoarterial biopsy catheters by completing both the receiving inspection and device inspections.
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Advanced the FDA certification of the endoarterial biopsy catheter through overhauling and updating the quality control system, also preparing for the possibility of a quality system audit.
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This included fully updating the Device Master Record and Device History Record as well as documenting and determining the training required for all new employees.
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Developed and presented recommendations that were adopted to update the quality control systems and make design additions to the endoarterial biopsy catheter.
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Planned and led Quality Control and Manufacturing meetings.
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Reported directly to the CEO and participated in company leadership meetings.
2022 - 2023
Catheter Manufacturing Engineer Intern
Vascular BioSciences
Goleta, CA
Internship with the Catheter Engineering Team of Vascular BioSciences. Worked on production of the endoarterial biopsy catheter along with aiding in product CAD and quality control.
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Built endoarterial biopsy catheters that were successfully used for animal trials.
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Catheters I built had a higher rate of success than previous iterations.
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Aided in the design of additional components for the endoarterial biopsy catheter using Solidworks computer aided design, as well as 3D printing fabrication.
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Part of the team working on the submission of an original IDE to the FDA. Focused on documenting all engineering drawings of the device as well as Solidworks models.
2021 - 2022