Scott Hanson Email & Phone Number

Eden Prairie, Minnesota, United States

Fridley

Developing and managing a world class Design Lab, Materials Test lab and Design Test Lab environments that help drive both innovation and collaboration across Neuro and the RTD organization. Provide technical and functional leadership for the Therapy Delivery Systems Design Lab. Responsibilities include planning, purchasing and maintenance of the lab equipment/environments and resource management to develop lab staff. Oversite of all the developmental builds and documentation. Most recently we completed the design, development and product line transfer of SENSIGHT™ DIRECTIONAL LEADS for DBS Therapy to our high volume manufacturing facilities.• Engineering & Technician Management and Project Resourcing• Developing 3D Printing Technologies in Neuro; purchase equipment, design online request system, quarterly reports, inventory, 3D display, train staff• Leader in 3D printing within Medtronic• Researching and Developing R&D Tools/Equipment Technologies• Capital Equipment Investments; laser technology, welding technology, etc…• Author the Design procedure, Tooling and PM procedures• Participant in annual FDA, TUV and internal audits related to Cal/PM • Created “Development Work Order” to document builds; concepts thru DVTResponsible for all the development of 3D printing within Neuro. I lead a monthly all Medtronic 3D printing meeting. In 2020, I designed a face shield with a Stratasys engineer and organized all Medtronic 3D printing centers to 3D print ~10,000 face shields and have Stratasys distribute them to our health care professionals across the country. This face shield design was used in the Stratasys Covid-19 Coalition which multiple companies across the country partnered up in 3D printing over 100,000 face shields for our healthcare heroes.

Fridley

Responsible for leading the design, development and relaunch activities for Neuro Therapy Delivery external test lead cables for InterStim™ SureScan MRI lead.• Updated Product Specifications and DFMEA documents • Root cause analysis by replicating failure mode on the bench• Designed/Built concept prototypes (3D Printing) and developed new test plans • Authored Design Concept Down Selection Report• Worked with operations vendor to build redesigned cables for DCT/DVT testing • Authored DVT Report and Transferred design to operationsLeading a small development team and effectively communicating progress and plans to the core team. Relaunched the new design with no returns due to the design changes and design margins built into the new design. This is currently in production and being used worldwide. Please reference this Youtube video to review the InterStim™ Therapy: Basic Evaluation using the enhanced Verify™ System and the external cables I designed.https://www.medtronic.com/us-en/healthcare-professionals/therapies-procedures/urology/sacral-neuromodulation/education-training/videos.htmlActivities include creating Product Specifications, DFMEA, Design Concept Selection Report, concept development proto-types & test plans, cadaver studies, product test development, supporting manufacturing development and transfer. Leading a small development team and effectively communicating progress and plans to the core team.

Fridley, Mn 55432

Contract engineer through Apex Systems, Inc. Responsible for the design development activities for the percutaneous extension cable for the Advanced Evaluation Test of the InterStim™ SureScan MRI lead, Sacral Neuromodulation and the new tunneling procedure to implant the perc extension to the Lead.• Reference Youtube video: https://www.youtube.com/watch?v=l56g0_9mrsU to view new tunneling procedure and perc extension• This project led me in creating 5 different patents• Planned and executed physician attending cadaver studies• Designed a new packaging system• Designed an alternative implant method that was vetted via the cadaver labs (VOC)• Design for manufacturability focus• Worked side by side with manufacturing engineering to optimize processes• Design Freeze well ahead of schedule• Currently in production and being used worldwideActivities include creating Product Specifications, DFMEA, Design Concept Selection Report, concept development proto-types & test plans, product test development and supporting manufacturing transfer activities. I Led a small development team and effectively communicated progress and plans to the core team.

Responsible for managing and leading R&D engineering teams in designing, developing and commercializing products for our customers. Maintaining and coordinating project schedules and tasks with internal and external team members. Responsible for budget, resources and technical leadership for multiple numbers of projects that range from full development projects to small problem solving projects. Responsibilities include managing and developing mechanical engineers and designers. Examples of projects include: Diagnostics: Managing a 10 person multidiscipline team in developing a proprietary electromechanical DNA technology for worldwide launch. Responsible for technical leadership, project scheduling, coordinating tasks, documenting project activity, resource needs, project reporting and billing.  Orthopedics: Managing and leading a mechanical engineering and design team in the development of a novel polymer cable implant. Technical activities include experimental methods to select optimal high-strength material and developing reliable end terminations. Fluid Delivery Systems: Managing and leading a mechanical engineering and design team in the development of a novel handheld fluid management device.  Orthopedics: Managed and lead a multidiscipline team from design concept to 510(k) approval to initial US launch of a new trauma system including the implants and surgical instruments, which included a new power drill instrument. Responsible for all project activities: planning, resources, working with a tight budget, and assuring all product development requirements were met and documented. Project DHF was transitioned to the customer and passed an FDA audit. Cardiology: Investigated and analyzed a new left atrium mapping catheter product for future design improvements utilizing voice-of-customer interviews and experimental methods.

Fridley, Mn 55432

Contract engineer through Three Point Solutions, Inc. Responsible for R&D engineering and design activities. Writing product specification rationales, product specifications, feasibility test protocols and reports, and design verification test protocols and reports. Worked towards qualifying the ONS (Occipital Nerve Stimulation) system for a clinical study and market release. Specifically developing and testing (axial, static and cyclic) ONS leads.

New Brighton, Mn

Responsible for hiring and managing R&D staff, organizing project teams, project plans, project budgets, overseeing project performance and reviewing personnel performance. Each project required negotiating contracts with our partners. Developed and maintained healthy relationships with our design and development partners. Hired six R&D engineers, eight technicians and other supporting personnel. Managed the Gemini project team from concept to market release. The Gemini handle included two revision upgrades to the electro-pneumatic controller and a total redesign of the disposable Mercury handle.  Managed and lead my patented Sidewinder™ project from concept to FDA clearance.  Managed and lead the “Apollo” development team that transformed a pneumatic system to an electric system. The Apollo team competed with an internal project team (DCI) and the Apollo Team’s design moved forward based on the recommendations of the two teams.  Gave a presentation to medical device industry R&D directors and VP’s for outsourcing R&D at the Marcus Evans Medical Device R&D Summit in December 2008.Senior Research and Development Engineer 10/2006- 2/2007Managed and lead the product development redesign team from the initial clinical design to the first commercial orbital atherectomy system to be launched in the US market.  Initially lead a cross-functional team of engineers and handpicked outside partners to redesign the OASIS Clinical IDE system to be a viable commercial product. The Mercury disposable handle and electro-pneumatic Mercury controller project was the first generation product for CSI. This project took only 9 months. Researched and established two partners, a design group (Redgroup) and an electronics group (Minnetronics) for the Mercury, Gemini and Apollo development teams. Researched, implemented and used Solidworks 3D CAD modeling system.

Performed product, process development & manufacturing responsibilities in designing, developing, qualifying and producing the 15mm, 20mm, 25mm & 30mm Premere PFO Closure Designs. Supervised up to 3 Mfg’ing/PD engineers and 3 Mfg’ing/PD technicians. Responsible for hiring,  Developed the proprietary nitinol electropolishing processes used to mfg’r the Premere™ PFO implant system. Developed nitinol heat treatment processes to shape set and Af set nitinol implant components. Developed a unique suturing process/design configuration on the left atrial implant. Responsible for completing 4 Design Verification builds, 3 clinical builds, all related documentation to document these builds (MVP’s, OQ’s, PQ’s, PPQ’s, Process FMEA’s, print package, MP’s, shop travelers, IP’s, operator training, etc.). Responsible for setting the direction for engineering development activities to continuously improve quality, yields, cost, throughput and capacity with new fixturing & new process technologies.organizing, prioritizing and reporting on process development and manufacturing engineering activities. After St. Jude aquired Velocimed (4/06) I also had the responsibility of being the process development core team member for the Premere Project.

Maple Grove, Mn

Lead Process Development Engineer responsible for designing and developing the nitinol electropolishing processes used to manufacture the Premere TM PFO Closure System.

Responsible for product and process development. Also worked to qualify new products for launch. Directly supervised and developed technicians. Completed 5 Design Verification Builds and 3 Clinical Builds. Developed processes and equipment to manufacture a stronger and tougher cross linked LLDPE balloon catheter using a new balloon forming machine. Developed an improved heat bonding process and equipment. Redesigned filter disks for the Duett™. The new design reduced costs by 97%.

Research and Development Engineer1997-2000, Performing R&D responsibilities in several cardiology OTW & Monorail stent delivery system projects. Responsibilities included: designing, developing and qualifying new products for launch. Project team leader from concept phase through launch.  13 patents on various stent delivery designs, stent crimping processes and distal embolic protection shaft designs. Lead a project team to design and manufacture the first 9mm NIRoyal Elite™ stent delivery system that was to incorporate “Sox” technology. Developed video test equipment used to analyze and make design changes to optimize stent deployment. 9mm NIRoyal Elite™ project created patents on a unique stent crimping process and two stent delivery system designs.Process Development Engineer1993-1997, Performed PD and QE responsibilities in several cardiology product development projects. Responsibilities included: developing new manufacturing processes, validating new products and processes, building clinical test catheters, transitioning new product lines from development to manufacturing (domestic and international) and developing new technologies. Designed, developed and implemented a patented spiral balloon protector (patent 5,893,868. Issued 4/13/99).  PD Engineer for 1st premounted stent delivery system, “NIR Primo”. Responsible for an international product line transfer (Ireland) and implementation of crimping equipment and processes used to secure the stent onto the balloon catheter. Pioneered the development of “bump” extrusion for injection molded balloon protectors. Other Balloon Catheter Projects; Fixed Wire Design-“Pivot”, OTW Design-“1/2 &1/4 size Leap Bandit”, “POC Bandit”, “NC Bandit” & Monorail Design- “NIR Primo”.Manufacturing Engineer1991-1993, Designed fixtures, improved processes, applied JIT and GMP principles, reduced scrap, lowered operating expenses for the Fixed Wire Balloon Catheters.Manufacturing Technician - 1990-1991

Ms, Manufacturing Systems & Engineering

Bs, Engineering