Steve Zaver Email & Phone Number

Minneapolis, Mn, Us

Marlborough, Ma, Us

Responsible for development of a Transcatheter Aortic Valve Replacement (TAVR) system consisting of a novel braided self-expanding nitinol valve structure with porcine tissue leaflets and an 18Fr transfemoral delivery system.• Successful development, submission and approval to conduct an Early Feasibility Study (EFS) in the US and Canada.• Direct the execution of multiple next generation projects, balancing resources, cost and timing to align with company objectives.• Manage an R&D Department of 16 Engineers and Technicians within a $9M R&D budget.

Responsible for setting the direction and guiding the development of a next generation delivery system for our TAVR device. Planning and executing pre-clinical studies to assess device functionality. Manage the Design Services (CAD) group.

Responsible for managing the development of a delivery system to implant transcatheter aortic heart valve (TAVR).

Engineering Lead or R&D core team member on numerous commercialized products. Emphasis was on designing industry leading technologies on a rapid development cycle. Some of the key projects were:•Delivery System technical lead on EverFlex Entrust self-expanding nitinol stent system. The delivery system is a one-handed, 5F, .035” guidewire compatible triaxial design. Catheter consists of a PTFE lined, braid reinforced retractable sheath for ease of stent deployment. The integrated isolation sheath provides increased stent deployment accuracy.•Delivery System technical lead on venous self-expanding nitinol stent system.•Delivery System core team member on directional atherectomy device.•R&D core team member on two different PTA product lines. One was an .018” guidewire compatible coaxial shaft design with a co-extruded inner lumen. The other was an .035” guidewire compatible multilumen design which optimized trackability and crossability, while providing the industry lowest deflation times for 200mm balloons.•Process Development and Design team member on SpiderFX, a braided nitinol embolic protection device with rapid exchange (RX) delivery and recovery catheter. Novel nitinol braiding designs led to multiple patent filings. Other key activities:• Frequent contributor to company Standard Operating Procedure for the overall product development process.• Participated in over 30 pre-clinical studies involving porcine, sheep and canine models. Wrote and executed GLP and Non-GLP study protocols.• Wrote and executed numerous Design Verification and Design Validation protocols/reports.• Managed Engineers and R&D Technicians, providing project guidance as well as mentoring. Led 1 to 5 direct reports during various projects.• R&D team member for numerous regulatory submissions, including CE Mark, 510K and PMA’s.• Manufacturing background enables me to develop novel designs that are readily manufacturable.

Minneapolis, Minnesota, Us

Process Development Lead on a Percutaneous Left Atrial Appendage Transcatheter Occlusion Device. Device is a permanent implant consisting of a nitinol self-expanding frame covered with ePTFE. Led process validation activities to transfer first generation device assembly line from California to Minnesota. R&D team member on second generation device consisting of new delivery system.Prepared and executed process validations for Installation, Operational and Performance Qualifications (IQ, OQ, PQ). Implemented cycle time and cost improvement projects on nitinol forming process, catheter bonding, reflow, tipping, laser welding, electropolishing, and laser bonding.

New Brighton, Mn, Us

Lead cross-functional teams to manage new projects from concept through process capable manufacturing. Engineering responsibility for overall project outcome. Projects involve injection molded plastic components and assemblies for implantable and disposable medical devices. Conduct Process Qualifications and Validations of injection molding process. Member of Material Review Board. Clean room manufacturing experience: Injection molding, Assembly, ultrasonic welding, and resistance welding.

Managed Engineering Department of 6 that was responsible for development of all new injection molding projects. Acting Project Engineer for Medical Market. Major projects involved components for the blood perfusion market.

Manage all phases of new project development: Design, prototypes, manufacturing process development, and ramp up to full-scale production. Process FMEA development. Member of QS9000, and SPC implementation teams. Managed many projects involving implantable pacemaker / defibrillator headers.

Development and improvement of manufacturing processes for injection molding, transfer molding, grinding, coil winding, and manual assembly.