FloSpine Holdings Inc, a Delaware Corporation is the parent company of FloSpine, LLC

FloSpine, LLC is a leading medical device company that designs best in class spinal implants who's anatomical design allows for better surgical placement, creating improved patient outcomes with instruments engineered to work effortlessly in the hand of a trained surgeon. We are located in the Research Park of Florida Atlantic University.

• Participate as a senior management team member responsible for overseeing engineering project progress against forecasted objectives, specifications, timelines and budget. Responsible for managing the engineering department of designers, engineers and product managers. • Work close with designing surgeons in and out of the O.R. during the various stages of product development.• Manage and provide technical direction to project teams developing new product design features, specifications and quality requirements.• Oversee mechanical and cadaveric testing to industry standards.• Perform exposures on cadaveric specimens in labs. to evaluate new implants and instruments.• Compile and submit new products to FDA and obtained 510(k) clearance. Communicate with the FDA on a regular basis.• Successfully designed and launched a full range of PEEK interbody devices, deformity system, minimally invaisive trans-facet pedicular screw system and a new facet fixation screw system.• Worked with senior management on the acquisition of US Spine by Amedica Corporation. Presented company portfolio to a number of leading orthopedic companies during the marketing phase.• Attended medical conventions and lectures. Exhibited products at company booth.

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• Supervise and manage a team of designers, engineers and product managers in their daily activities as the Senior Project Team leader in the design and development of spinal implants and instrumentation.• Conducted project team meetings with essential departments for the complete design cycles of various projects. Launched products from initial design to market within established time frames.• Produce Project timelines (Gantt Charts), develop and maintain budgets for multiple projects.• Worked close with designing surgeons in and out of the O.R. during the various stages of product development.• Establish test methods for product validation and monitored testing of devices to ASTM standards and FDA guidelines.• Perform exposures on cadaveric specimens in labs. to evaluate new implants and instruments.• Compiled and submitted new products to FDA and obtained 510(k) clearance. Communicate with the FDA on a regular basis.• Successfully designed and launched a full range of PEEK interbody devices (MIS inserter), 2 cervical plate systems and pedicle screw system.• Produced and maintained the Project Design History Files according to FDA and ISO requirements. Personally passed FDA and ISO audit of DHF.• Communicated regularly with suppliers in resolving design issues, obtained quotes and approved P.O.’s for the manufacture of implants and spinal instrumentation.• Prepared and presented product training to sales representatives and product development updates to surgeons.• Attended medical conventions and lectures. Exhibited products at company booth.

• Supervise designers and engineers in the development of spinal implants and instrumentation using 3D CAD and Finite Element Analysis.• Consult with surgeons to design new spinal implants and Instruments from initial concept to product launch.• Submitted new products to FDA and obtained 510(k) clearance. Communicate with the FDA on a regular basis to monitor progress of submissions.• Assisted surgeons in the O.R. on the proper surgical technique for implanting medical devices.• Monitored testing of devices to ASTM standards and FDA guidance documents.• Produced and maintained the project Design Control Process and Project Design History Files according to FDA requirements. Conducted team meetings with other essential departments.• Performed evaluation surgeries in cadaver laboratories with designing surgeons.• Prepared and conducted surgical implant technique training presentations for surgeons and sales personnel.