Russell G. Hodge
`25 Center Ct
`Laguna Niguel, CA 92677
`(978)239-7315
`russell.g.hodge@gmail.com
`
`
`To secure a senior leadership position with a company in the
`Medical Device Industry offering excellent growth potential for a result-
`oriented individual.
`
`
`
`
` Proven Leadership Abilities in Operations/Research and Development
` Proven Leadership Abilities on Cross-functional New Product Teams
` Demonstrated Ability to lead complex organizations to achieve results
` Excellent Problem solver/Hands-on engineering skills
` Strong Background in Development and Implementation of Engineering
` and Manufacturing Systems
`
`
`
`
`
`
`OBJECTIVE:
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`
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`
`
`PROFESSIONAL
`
`QUALIFICATIONS:
`
`Sr. Program Director
`Medtronic CoreValve
`Irvine, CA 92618
`Provide overall leadership to the $700MM CoreValve acquisition within the
`Medtronic SH business. Responsibility includes leading a cross-functional team
`of director level individuals to drive R&D, RA, Clinical, Finance, Marketing, Mfg
`and Quality to achieve geographic access and market leadership across the
`world. Activities include regulatory approvals, including IDE/PMA, pivotal clinical
`studies in all major geographies and a suite of product development projects
`including new indications. Responsible for 100+ people across 6 different
`geographies and an annual total budget of $85MM.
`
` Created the CoreValve strategic plan to deliver acquisition economics.
` Successfully initiated US IDE study for first SES valve technology.
` Created an operating structure that drives results across 6 locations
` Delivered development programs on schedule to achieve ~40% growth.
`
`Vice President/Site Leader
`Medtronic Vascular
`Danvers, MA 01923
`Provide overall leadership to 600+ employees at the Danvers Medtronic Vascular
`Site. Responsible for the development, manufacturing, marketing and distribution
`of over 5000 disposable devices that contributed $230MM in revenue. Additional
`areas of responsibility include quality assurance, regulatory affairs, clinical
`research, finance and human resources. Worked with the Cardiovascular division
`senior leadership to develop a site charter that creates/leverages technologies
`across multiple Medtronic businesses. Changed the perception of the site from
`
`primarily manufacturing to that of a technology development center.
`
` 
`
`
` Authored the Danvers site 5 year strategic plan.
` Created an environment of collaboration and developed site-wide
` objectives.
` Lead a division-wide team to “operationalize” the division’s 5yr strategic
` plan
` Implemented lean-sigma into the facility/culture.
`
`1
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`EXPERIENCE:
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`April 2009
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`November 2005
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`
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`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1019-1 - Page 1
`
`

`
` Created an innovation initiative that drove process improvement and
` increased intellectual property generation by 200%.
`
`Vice President of Research &Development
`Medtronic Vascular
`Danvers, MA 01923
`Provide R&D leadership to the Medtronic Vascular’s Coronary Research and
`Development group. Responsible for the development of products to treat
`atherosclerosis including guiding catheters, wires, embolic protection, and other
`minimally invasive catheter technology. Created a team to develop percutaneous
`structural heart therapies that work across multiple Medtronic divisions.
`Additional areas of responsibility included advanced technologies, process
`engineering, equipment engineering and a patent group. Managed a $12MM
`R&D budget and about 60 engineers/technical personnel.
`
`
` Created R&D functional plans including a 5 year technology map.
` Implemented Design for Lean Sigma principles into R&D process.
` Developed a comprehensive Program Management curriculum.
` Worked with researchers to develop and refine potential therapies.
` Created intellectual property positions in the area of Structural Heart Disease.
`
`
`
`Vice President of Coronary Research &Development
`Medtronic Vascular
`Santa Rosa, CA 95403
`Provide leadership to the Medtronic Vascular’s Coronary Research and
`Development group. Responsible for the development of stents, drug eluting
`stents and stent delivery systems. Additional areas of responsibility included
`process engineering, equipment design/development, machine shop and design
`control functions. Collaborated with external partners to develop combination
`drug/device therapies to locally treat vascular disease. Lead a group of 100
`engineers, technicians and responsible for a $30MM research and development
`budget.
`
` 
`
` Created and implemented new technology research and development plans.
` Developed and initiated the clinical study of the Endeavor DES and went from
` a 5th to market position to 3rd.
` Developed and commercialized the Driver Cobalt Chromium stent system.
` Worked with researchers to develop and refine potential therapies.
` Integrated acquisitive R&D programs into internal development.
`
`Director of Science and Technology
`Arterial Vascular Engineering-Medtronic Incorporated
`Santa Rosa, CA 95403
`Responsible for the development of treatments for the reduction of restenosis.
`Collaborated with external partners to develop drug/radiation/device therapies to
`locally treat vascular disease. Directed a focused group of thirteen engineers and
`eight technicians in the creation and prototyping of catheter based devices used
`in local drug delivery, optical transmission and radiation devices. Worked with
`researchers and physicians to evaluate viability of various devices and drugs and
`potential restenosis treatments.
`
`
`
`2
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` 
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` Created and implemented 5 yr new technology strategic plans.
` Developed preclinical protocols for evaluation of concepts.
`
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`December 2003
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`February 2001
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`June 2000
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`
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1019-1 - Page 2
`
`

`
` Performed external technology evaluations of potential acquisitions.
` Worked with researchers to develop and refine potential therapies.
` Created intellectual property positions in areas of PDT, Drug delivery and IRT.
`
`R&D Program Manager
`Arterial Vascular Engineering
`Billerica, Massachusetts 01821
`Responsible for the development of treatments for the reduction of restenosis.
`Collaborated with external partners to develop drug/radiation/device therapies to
`locally treat vascular disease. Directed a focused group of three engineers and
`two technicians in the creation and prototyping of catheter based devices used in
`local drug delivery, optical transmission and radiation devices. Worked with
`researchers and physicians to evaluate viability of various devices and drugs and
`potential restenosis treatments.
`
` 
`
`
`
` Created and implemented new technology research and development plans.
` Developed preclinical protocols for evaluation of concepts.
` Performed external technology evaluations of potential acquisitions.
` Worked with researchers to develop and refine potential therapies.
` Created intellectual property positions in areas of PDT and IRT.
`
`R&D Program Manager
`USCI division of C.R. Bard Incorporated
`Billerica, Massachusetts 01821
`
`Responsible for the development and implementation of two new guiding
`product lines. Directed a multi-disciplined program team in all aspects of product
`development and commercialization including; R&D, Mfg, Mktg, RA, and QA.
`Introduced over 400 new items within sixteen months Worked with physicians to
`evaluate proposed designs. Performed technical sales training for all domestic
`and European sales personnel.
`
` Created and executed detailed Program Plans.
` Delivered 400 new end items 5% ahead of schedule within cost targets.
` Negotiated OEM contract to acquire new technology rather than internally
` develop.
` Presented monthly updates to Cardiology Management Board.
` Authored Program resource models and associated capital request.
`
`Engineering Section Manager
`Responsible for managing all aspects of USCI's Extrusion Engineering group,
`including the development and on-load of new extrusion processes, the
`development of equipment and the support of existing core technologies.
`Developed new extrusions for Bard's Angiography, Electrophysiology and
`Angioplasty Business Units. Directed a group of twelve engineers and ten
`technicians. Responsible for a two Million dollar departmental engineering
`budget.
`
` Created Project resourcing models and technology capital plan.
` Developed a cost improvement plan for an annualized savings of 750k.
` Created a process validation plan for validating over 130 extruded
` components.
` Performed Due Diligence Assessment of a potential business acquisition.
`
`3
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`April 1998
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`April 1997
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`January 1994
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`
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1019-1 - Page 3
`
`

`
` Received approval to purchase $1.4MM in new extrusion equipment.
`
`Senior Project Engineer
`Responsible for managing the product on-load process for multiple new
`
`angioplasty products. Presented monthly progress updates to Division
`Management Board. Managed six engineers and three senior technicians to plan
`and attain goals to reach departmental strategic objectives for time-to-market,
`product cost and availability.
`
` Lead New Product Introduction teams in developing and introducing new
` balloon dilatation catheters.
` Managed the process development of balloon molding for all new products.
` Introduced a new Hydrophilic coating process into manufacturing.
` Performed Due Diligence Assessment of a potential business acquisition.
` Developed a comprehensive source inspection program with a critical
` supplier.
`
`Project Engineer
`Responsible for managing the on-load of new products from R & D into
`manufacturing. Worked on USCI's top priority new products. Developed project
`time-lines and resource requirements using project management software.
`Developed repeatable production processes using experimental design
`techniques. Created all process/inspection specifications in accordance with
`GMP requirements. Performed comprehensive Process Validations on all new
`processes in accordance with FDA guidelines. Process experience includes:
`injection molding, thermal bonding, solvent bonding, UV curable solvent bonding,
`plasma surface treatment, ultrasonic welding, balloon molding, and hydrophobic
`and hydrophilic coating. Authored manufacturing sections of PMA supplements
`submitted to the FDA. Provided leadership and direction for one engineer and
`three senior technicians.
`
`Advanced Manufacturing Engineer
`Represented manufacturing on new product introduction teams that were
`responsible for the release of USCI's Force, Sprint and Solo Balloon catheters.
`Provided manufacturing engineering support on the above products and all
`associated processes. Created and updated manufacturing documentation as
`required. Developed poka-yokes and fixturing for continuous yield and efficiency
`improvements.
`
`Manufacturing Supervisor/Engineer (2nd Shift)
`Supervised 12 hourly workers in the production of Balloon catheters. Developed
`and carried out monthly production plans. Participated in the development of self-
`managing work teams. Teams were responsible for all facets of manufacturing,
`including; materials planning, production planning, and operator training.
`Responsible for all Manufacturing Engineering support of second shift
`operations. Implemented a Zero Defect successive inspection program that
`increased production yields from 65 to 90%. Introduced basic Just-in-Time
`manufacturing techniques that reduced lead times from 45 to 5 days and work-
`steps from 14 to 7 operations.
`
`4
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`May 1993
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`May 1991
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`January 1990
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`December 1988
`
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`
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`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1019-1 - Page 4
`
`

`
`EDUCATION:
`
`
`
`University of Massachusetts at Amherst; Amherst, Massachusetts 01003
`Bachelor of Science in Mechanical Engineering - December 1988
`
`New Hampshire College; Portsmouth, NH 03801
`Master of Business Administration – 1996-1998 75% Completed
`
`PROFESSIONAL Coopers & Lybrand-Design for Excellence, Fall 1989
`TRAINING:
`
`M.I.T.-Design of Experiments, Summer 1992
`
`
`
`FMEA - Worcester Polytechnic Institute; Spring 1994
`Member Society of Plastics Engineers, since 1991
`Member American Society of Quality Control since 1996
`Medtronic Sr. Leader Training April 2003
`WPI Program Management Certification 2007
`
`
`ACTIVITIES:
`Family, surfing, car restoration, hunting, photography and music
`
`REFERENCES: Will be furnished upon request
`
`
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`
`
`5
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1019-1 - Page 5