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Engineering leader with 30 years of experience in engineering design. Primary expertise is in the field of medical device implant design, testing, prototyping, and regulatory filing. Specific devices that have been designed include cardiovascular implants and delivery systems (stents, valves, filters, and ventricular assist pumps) and orthopedic implants (joint replacements, spinal devices, and trauma products). I’ve built highly effective R&D teams, leading and mentoring a full range of colleagues, from new engineering graduates up to accomplished engineers, scientists, and doctors. Specialties: R&D, Team Building, Cardiovascular, Combination Drug/Device, Structural Heart, Orthopedics, Spinal, Regulatory Filings, Fatigue Analysis and Testing, Design Optimization, Finite Element Analysis (FEA), Nitinol Device Design, Analysis, and Testing, Innovation/Intellectual Property.
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PresidentWjh Engineering Consultants, Llc Jun 2004 - PresentSignal Mountain, UsAssisting medical device companies with strategic R&D, project planning, regulatory approach, and all aspects of product design; from concept formulation, design, prototyping, and testing of devices through submission to FDA and other regulatory agencies.
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Medical Device ContractorWjh Engineering Consultants, Llc Jun 2004 - PresentSignal Mountain, Us
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Vp Of R&DXeltis Aug 2024 - PresentEindhoven, North Brabant, Nl -
Vp Of R&DXeltis Jun 2023 - Aug 2024Eindhoven, North Brabant, NlLed R&D team to successful FDA submission into an IDE trial of the aXess vascular access conduit for dialysis patients, using the endogenous tissue restoration (ETR) technology. This technology utilizes electrospun nanofibers of supramolecular polymer which promote tissue growth prior to bioresorption, leaving natural tissue in the place of the polymer. Additionally progressed two other programs using the same technology, into FIH clinical trials in other vascular treatments.
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Vp Of R&DEuphrates Vascular Dec 2021 - Apr 2023Successfully led efforts of cross-functional team to FDA submission and approval of an EFS IDE stroke trial of the Pulse NanoMED System. -
Director Of Implant R&DIntact Vascular Aug 2013 - Jun 2021Director of R&D from start-up to acquisition. Designed/developed from concept to commercialization - three implants for the repair of tissue dissections that occur during balloon angioplasty in the upper and lower leg. Class III devices, having gone through European and US clinical trials.
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Director Of R&D, Philips / Intact VascularPhilips Aug 2013 - Jun 2021Philips purchased Intact Vascular, September 2020.
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Director Of R&D (Consultant)Vesper Medical, Inc. Oct 2016 - Sep 2020Wayne, Pa, UsDesigned and tested the Vesper DUO™ Venous Stents, which are purpose-built for venous stenting, with an unmatched combination of strength and flexibility designed to meet the multiple anatomical challenges presented by vein mechanics. Vesper was purchased by Philips, January 2022. -
Manager Of R&DAbbott Vascular Devices Jan 2002 - Jun 2004Abbott Park, Illinois, UsManaged the stent design team, FEA and durability testing team, the pre-clinical testing team, and the Nitinol material development team. -
Manager Of R&DGuidant Dec 1997 - Jun 2004Marlborough, Ma, UsConcurrently managed three teams of engineers performing carotid and peripheral stent development; the design, analysis, and in-vitro testing team, the pre-clinical and in-vivo test team, and the stent material testing and development team.Prior to running service teams above, I ran the Acculink Carotid Stent development team, taking the project from final concept, through clinical trials, to FDA approval and product launch. This was the first FDA approved carotid stent in the US. -
Senior R&D EngineerSmith & Nephew Orthopaedics Mar 1993 - Dec 1997Watford, Hertfordshire, GbFEA and mechanical testing of orthopedic implants and constructs - Spinal, Hip, Knee, and Trauma implants and delivery systems. -
Research EngineerUnited Technologies Research Center May 1992 - Mar 1993East Hartford, Ct, UsFinite element analysis on aircraft engines, composite structures, metal forming, etc.
Jim Harrison Skills
Jim Harrison Education Details
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Rensselaer Polytechnic InstituteMechanical Engineering -
Worcester Polytechnic InstituteMechanical Engineering
Frequently Asked Questions about Jim Harrison
What company does Jim Harrison work for?
Jim Harrison works for Wjh Engineering Consultants, Llc
What is Jim Harrison's role at the current company?
Jim Harrison's current role is Medical Device R&D Leader.
What is Jim Harrison's email address?
Jim Harrison's email address is ji****@****sci.com
What is Jim Harrison's direct phone number?
Jim Harrison's direct phone number is +150868*****
What schools did Jim Harrison attend?
Jim Harrison attended Rensselaer Polytechnic Institute, Worcester Polytechnic Institute.
What are some of Jim Harrison's interests?
Jim Harrison has interest in Innovation, Running, Biomedical Research, Cycling.
What skills is Jim Harrison known for?
Jim Harrison has skills like Medical Devices, Biomedical Engineering, R&d, Fda, Mechanical Engineering, Finite Element Analysis, Design Control, Orthopedic, Iso 13485, Testing, Cross Functional Team Leadership, Product Launch.
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