Frank started his professional career in 1995 working at Foster-Miller Inc. on cutting edge R&D projects such as: Liquid Crystalline Polymers for rocket propulsion fuel lines, electrical cables for submarine launch systems, and Venusian Aerobot projects for NASA. In 2000, Frank accepted an engineering position at Medtronic AVE within the Extrusion group to facilitate line extensions and improve efficiencies. From there, Frank accepted various new appointments within Medtronic including Guide Catheter Mfg.(2001), AngioLink Closure Device Development (2004), and Contract Mfg. Program Management (2006). Frank continues to work as a PM and has led many development, quality, service, and cost improvement projects under the Medtronic umbrella and also within the workspace of various contract manufacturers including: STD Inc., Avail Medical, Atek, FlexMedical, and most recently Flextronics and Plexus Corp. Frank is currently appointed to lead cross-functional team(s) to establish manufacturing and testing capabilities at Plexus needed to transfer the next generation renal denervation generator from Medtronic to Plexus Scotland and Malaysia facilities. Educational Background: BS Plastics Engineering (UMass- 1996) MS Plastics Engineering(UMass- 1996) ASQ Certified Quality Engineer (2004-present) MBA (Endicott-2008)

Program Manager @ CardioVascular Contract Manufacturing Program Manager From May 2000 to Present (15 years 8 months) Program Manager @ Responsible and accountable for the quality and service levels of Inflation Devices as well as endovascular products such as Diagnostic Catheters, Introducers, and Transeptal Catheters. Sale of these products generated $50+ million dollars (USD) in gross revenue for Medtronic. Successfully implemented Phase I of a critical ABS replacement project (SABIC resin) in time to avoid any service disruptions. This involved navigating through various testing failures, establishing robust corrective action, and gaining cross-functional alignment on results to ensure timely approvals of final validation documentation. From May 2000 to Present (15 years 8 months) Frank's Resume - June 2011 @ From January 2000 to Present (16 years) Program Manager @ Was responsible and accountable for the quality and service levels of 800+ finished goods. Product portfolio included: heart tissue stabilizers, arterial/venous cannulae, suction circuit devices and surgical support products. Sale of these products generated $120 million dollars (USD) in gross revenue for Medtronic annually. Supervised the Medtronic Mfg. Engineering team (stationed at the Contract Manufacturer’s plant) and directed cross-functional teams from Medtronic MN to support activities needed to improve backorders (99% service level goal). Continue to drive quality improvement, and address material/tooling obsolescence issues. Assumed responsibility as Medtronic Corporate liaison to the contract manufacturer to ensure that strategic directives are applied to tier From January 2008 to January 2011 (3 years 1 month) Sr. Mfg. Engineer/Project Manager @ Lead a project to update high-level Process Failure Mode and Effects Analyses (PFMEA’s) which required extensive meetings and coordination with internal and external QA, MFG, RA, and R&D functions. This project encompassed all process controls, failures modes, and SOP requirements since the outsourcing of Dx products to Mexico.; Managed a cross-functional team of engineers assigned to fabricate and implement a duplicate Finished Assembly (F/A) line at the contract manufacturer’s new Class 100,000 cleanroom. Responsibilities included: weekly team meetings & action plans, reports/updates to Senior Staff, capacity analysis, manload models, IQ/OQ/PV protocol preparation & execution, regulatory considerations, & ROI calculations. Successfully completed a Dilator Capacity Upgrade project that required the development of an entirely new dilator tipping process (at 30% the cost of the original equipment) and corresponding IQ/OQ/PC/PV protocols/reports, work instructions, and training guidelines. Was responsible for managing capacity upgrades/improvements to other Subassembly processes at the Medtronic Danver’s Site. Processes included: Transition Sheath Forming, Pneumatic Cutting, Laser Cutting, EFD Filling, Punching, and annealing. Lead an effort to transfer Hydrophilic Coating technology from SurModics, MN to Medtronic, MA. Achievements included: contract extension negotiations, Vendor business survey, capacity analysis, seeking competitive bids, coordinating coating room construction at Medtronic, and resolution of coating flaking & cracking issues. Prepared detailed project plans for Senior management in coordination with contract manufacturers for the purpose of assessing priorities and ensuring that all the elements needed for successful VCS1000 launch are in place at the right time. Was directly responsible for managing a full time Mfg. Engineer and Eng. Intern. Deliverables included: annual reviews, Individual Development Plans, and merit awards. From January 2004 to January 2006 (2 years 1 month) Senior Manufacturing Engineer @ Supported department wide lean initiatives upon successful completion of Medtronic-sponsored Six Sigma Green Belt Training Course. Supported manufacturing processes, including: radio frequency bonding, insert injection molding, multicavity segment bonding, hot stamping and a variety of related custom and proprietary manufacturing operations. Responsible for the implementation of SPC monitoring techniques for high critically operations across Vector, Zuma, Z2, and Launcher guide catheter product lines. Developed and managed an SPC review program that utilizes daily SPC auditing groups, Engineering review boards, and shared network tracking logs. Prepared and executed Installation, Qualification, and Validation plans for new products as well as process and design changes for existing products, test equipment, packaging, and raw materials. Effectively utilized DOE and advanced statistical techniques in Validation reports in order to demonstrate required confidence levels per process and design FMEA’s. Installed and implemented an MTS Universal Testing machine and TestWorks system to measure catheter soft tip retention in accordance with Medtronic/FDA requirements for Installation/Operation Qualification and Gage R&R. Participated in three product failure investigations, which were resolved in a timely manner with minimized customer service level impact and effective corrective/preventative actions (subsequently recognized with a “Stellar Performer” award). Successfully modified the “Launcher” production line to increase throughput by 100% at only 14% the capital cost of an additional line. Was directly responsible for managing a full time Senior Engineering Technician and Intern. Deliverables included: annual reviews, Individual Development Plans, and merit awards. Resolved compliance issues in areas of Manufacturing, Process Controls, Materials Storage & Handling, and Statistics as a certified internal auditor for Medtronic Inc. From January 2001 to January 2004 (3 years 1 month) Extrusion Engineer @ Supported manufacturing processes, including: extrusion, braiding, inspection, core-pull, and quality testing (i.e. capillary rheometery, tensile, MFI, and moisture tests). Regularly conducted extrusion DOE’s for Qualification/Validation of new jacketing compounds, packaging materials, and process changes. Developed an algorithm for extruded shaft selection to minimize microcracking rejects in upstream processes resulting in excess of $120,000.00 in savings. Developed acceptance test methods for Illiac product line on Instron System. Identified and solved extrusion instability problems related to solids melt conveying. From January 2000 to January 2001 (1 year 1 month) Project Engineer @ Defence Contacts and limited commerical R&D projects. Specialized in LCP molding technolgies for NASA, DOE, DARPA, and the U.S. NAVY. From January 1995 to May 2000 (5 years 5 months) Project Engineer @ Was solely responsible for project management of the ongoing Martian Balloon Exploration Program. Responsibilities included: budget management, technical personnel and subcontractor selection and submitting timely quarterly and final reports to NASA. Successfully placed bids on several government research projects involving R&D applications including: components for liquid rocket engines, electrical cables for submarine launch systems and a planetary exploration project for NASA. Created a next-generation cable for use in Navy helicopter sonar applications, which incorporated fiber-optic technology to expand data transmission capabilities. Product is currently in commercial production. Acquired responsibility for failing Venusian Balloon Project and transformed it into an award-winning program now listed on a NASA web page for Small Business Innovation Research (SBIR) success stories. From January 1995 to January 2000 (5 years 1 month)

MBA, Business, 4.0/4.0 @ Endicott College From 2006 to 2008 M.S. Master; M.B.A. Master, M.S. Thesis @ Publications From 1996 to 1998 M.S, Plastics Engineering, 3.6/4.0 @ University of Massachusetts at Lowell From 1996 to 1998 B.S, Plastics Engineering, 3.3/4.0 @ University of Massachusetts at Lowell From 1991 to 1996 Frank Federico is skilled in: Medical Devices, Design of Experiments, Six Sigma, Manufacturing, R&D, Cross-functional Team Leadership, Quality Assurance, SPC, FMEA, Lean Manufacturing, Validation, Program Management, Leadership, ISO 13485, Design Control