Vein360 – Reprocessed Closure Fast Catheter
First Engineering Employee – R&D Engineering Intern
Vein360 is a medical device reprocessing company focused on bringing a sustainable option to the market for vascular surgeons utilizing the single-use, Medtronic ClosureFast line of radiofrequency ablation catheters. Through the rigorously validated reprocessing model, Vein360 can bring single-use devices back to OEM quality and cleanliness for a fraction of the price of a new device, while simultaneously reducing medical waste.
I joined Vein360 as the first full-time employee and first mechanical engineer on the project. I played an integral role in developing the early reprocessing model and building out a lab space and cleanroom to conduct trial runs of the process. I acted as a technical liaison between engineering/regulatory consultants and company management. I aided in the development of labeling and packaging for the catheter. I created documentation, testing procedures, equipment IQ/OQ/PQ, and verification/validation procedures to be included in the company’s submission to the FDA.
Assisted in the Development of Packaging and Labelling.
A Vein360 Reprocessed Catheter
Developed first generation cleaning protocol, including the design and build-out of a custom lumen flushing manifold.
Assisted in the development of custom packing.
Researched and Managed the Install of an Industrial De-Ionized Water System.
Project managed the procurement and installation of a Class 7 HEPA-filter clean room. I also designed the interior lay-out.
