Mechanical Engineer, medical devices, FEA, CFD, intellectual property

N.J. Coleman BSME Product Design and Manufacturing Professional

Cell 626-***-**** Newport Beach CA CA 92663 ****@************************.*** **************@*****.*** Summary

Product Concept to Manufacturing:

o Experienced in all phases of product design and manufacturing in multiple and overlapping roles from Machinist to Director in large and small company settings including start-up phase efforts. Early practitioner of “seamless prototyping” successfully compressing R&D schedule and costs. Verifiable $100 million results directly from personal initiative projects.

o Part of numerous profitable product launches in multiple industries with emphasis on Medical Devices, Defense, and Semiconductor sectors, patents granted in multiple market sectors. o Fully "hands on" capable. Experienced in metals, polymer, elastomer, electroforming, fiber optics, microfluidics, and composites design, analysis, and fabrication. Early adopter of FEA, CFD, Statistical Process Control, Sterolithography and 3D printing in polymers, metals, and composites. Built numerous successful prototypes and early launch product, developed new manufacturing techniques and equipment. o Experienced with CFR 21/ISO 13485 regulated industries, design and manufacture of class 1, 2 and 3 medical devices including coronary and neurological interventional and sensing catheters, respiratory devices, surgical laser tools, disposables, sterilizers, and others. Record of successful Medical Device Regulatory submissions and mitigation.

o Other industries include Instrumentation, Defense/DOD, Motor Racing, Technical Consulting, Intellectual Property, sports equipment, electroforming, biofuels, analysis (FEA, CFD), and aquaculture.

Computer Aided Design, Finite Element Analysis, Computational Flow and Thermal Analysis: o User/owner of Algor Multiphysics FEA (now Autodesk Mechanical Simulation) since 1995. o User/Owner of Blue Ridge Numerics CFDesign (now Autodesk Simulation CFD) since 2013. o User/owner of SolidWorks (CAD) since 1996.

o Record of FEA and CFD work used in successful defense of clients in litigation, prosecuting Intellectual Property issues, and multimillion dollar product manufacturing/design impacts. o User of PTC ProE-Wildfire 2009-2011.

o ANSYS user 2020-

Intellectual property, Patents and Patents pending: o Have unique technologies related to manufacture of miniature metal bellows and other thin walled electroforms, electroless forms, heat exchangers, optic sensors, mirofluidic devices, and others. o Granted Patents include USPTO 6604427, 7096737, 7284436, 7762526, 8022835, 8436261, 9360383, 10046126, 10160419, 10294091, 10571001, 10836624, 11383058 and others including, pending, and foreign. Major Employers, Full time regular W2 positions and full time W2 or corp-corp contract positions since 1986

Principal Development Engineer Symbient Product Development, Carlsbad CA (Acquired by RND Group) 7/21-

o Development and prototyping of medical diagnostic disposables for COVID detection. o Invented new techniques for low cost microfluidic chip manufacture.

Simulation Engineer, Torus Tech, San Clemente CA (relocated to France) 6/19-7/21 o Simulation (FEA, CFD) and implementation of physics research and high efficiency motor projects.

Lead Mechanical Engineer, Suspended Animation, Rancho Santa Margarita, CA (relocated to Lake Forest) 8/14-6/19

o Inventor and primary designer leading cross functional team developing novel portable, 3D Printed partial liquid ventilator system for medically induced hypothermia therapies. o Patents granted and pending include USPTO 10,046,126 and USPTO 11,383,058for patient heat exchanger and life support system.

Principal Mech. Engineering Consultant, Foliage Software, Fremont CA (Acquired by Altran) 5/13-7/14 o Patents granted and pending for products developed include USPTO 10294091 assigned to Pepsico. o Provided FEA, CFD, and medical device remediation services as required until acquisition by Altran.

Multiple titles and locations, Medegen Medical (Acquired by Cardinal, Carefusion, BecktonDickenson) 1/05-4/13

o Started as consultant, converted to R&D Engineer, Ontario CA 1/05-8/2006. Contractor, Palm Springs CA, 3/11- 1/13. Contractor/Principal Mechanical Engineer 1/13- 4/13 Yorba Linda, CA, Various other contracted services at various times.

o Provided FEA and medical device regulatory compliance services, participated in successful identification of infringement of Medegen intellectual property.

N.J. Coleman BSME Product Design and Manufacturing Professional Cell 626-***-**** Newport Beach CA CA 92663 ****@************************.*** **************@*****.*** o Saved a product line worth $100 million+ annually from impending non-viability, resolved open CAPA and resolved the greatest single company wide source of product complaints via application of personal FEA assets to impart design and process robustness in a personal initiative project. o Designed and managed testing program for Validation & Verification activities, assembled Design History File

(DHF), wrote the combined process/product FMECA allowing "modular configurability" of the infusion catheter product achieving 510(k) status, participated in Risk Assessment of product and processes and their modifications.

o Established capability for rapidly validating alternative elastomeric materials via FEA/virtual devices. o Introduced modular core liquid silicone rubber injection tool design resulting in 80% favorability to budgeted costs and lead time with simplified tool maintenance. o Redesigned medical devices for RoHS compliance, improved function, and cost savings of $250K annually.

Project Engineer, Marvin Engineering Inglewood, CA 2/09-1/11 o Serving defense and military vehicles industry.

o Design and FEA analysis of auxiliary power units and winching systems for armored combat vehicles. o Developed new thermally conductive dielectric heat-sinks and microfluidic heat exchangers using PVD thinfilm and electroform techniques resulting in lighter weight, lower cost, higher performance electric machine product.

Contractor or Sr. Mechanical Engineer, NorCal Products, San Diego CA (acquired by Pfeiffer) 5/98-2/09 o Various times and titles, most recent full time status 8/06-2/09 ending with closure of the San Diego facility. o Serving vacuum and semiconductor tooling industry. o Earned US patent # 7,762,526 for a new type vacuum/wafer fab process control valve. o Co-conceived, designed and prototyped a new line of FEA optimized high performance motor driven valves for silicon wafer processing equipment, an industry first and current standard for performance since copied by all major competitors and contributing to 22X growth of revenue during my employ. o Established and operated on-site prototyping and FEA capability using personal software and machine assets.

Sr. Mech E SI Technologies: Tustin CA, (Acquired/relocated by Vishay, 1/05). 12/03-1/05 o Started as FEA consultant, converted to regular employee1/04. o FEA and mechanical design of strain gauge based load cell components and associated systems for commercial, military, and medical devices, design of vehicle mounted on-board sensors and systems as required until acquisition by Vishay and closure of local facility.

Contractor, American International Technologies, Cypress CA. (Acq'd by Ushio America 1/02). 2/01-5/02 o Contract completion with multiple extensions for additional work to 5/02 in transfer of acquisition. o FEA, design of wafer processing equipment, electron beam medical device sterilization equipment and others. o Design of wafer processing equipment.

Sr. Mech. Engineer, Tylan General, San Diego CA. (Acq'd by Millipore Corp,Bedford MA 5/98) 8/94-8/98 o Consultant 8/96, converted to regular employee 10/96. o Retained to develop silicon wafer processing devices using proprietary bellows and optic sensor technologies. o Established and operated Tylan’s on-site prototyping and FEA capabilities, addressed mechanical design and metallurgical issues as needed until sale and relocation of company.

Camino Laboratories: San Diego CA. (Acquired by Huyer-Schulte). 1/92 - 7/94, vendor to 6/98 o Manufacturing Engineer for neurocare fiber optic pressure sensing catheter product. o Introduced statistical sampling and process control, enhanced product yield, developed new manufacturing procedures for fiber-optic medical pressure sensing catheter product as needed to position the company for sale.

o Vendor of electroless formed bellows and machined components to 6/98.

Advanced Development Engineer, Devices for Vascular Intervention: Redwood City CA (Acquired by Eli Lilly, relocated) 8/89-1/92

o Developed "next generation" vascular atherectomy devices and manufacturing techniques. o Reconfigured development equipment into manufacturing assets aligning with post acquisition management

Mallinkrodt Medical (Acquired by Tyco) : St. Louis MO 12/87-8/89 o Developed novel in-vivo fiber optic blood chemistry sensing devices until project cancellation by new management.

o Concieved of and implemented process cost saving techniques for regular product totaling $800K annual.

Engineer, Ethox Corp: Buffalo NY. 8/86 - 12/87

o Developed a laser surgical device manufacturing process as a personal initiative project resulting in winning a manufacturing contract away from a Japanese company and record earnings. N.J. Coleman BSME Product Design and Manufacturing Professional Cell 626-***-**** Newport Beach CA CA 92663 ****@************************.*** **************@*****.*** 1099, part time, and equity positions (partial not including contract converted to "regular" or W2)

Equity Partner, Net Controls LLC, Santa Clara CA. 4/09- o Design of vacuum process control devices and motor driven control valves for start-up tech firm. Patents pending.

President, Technology, Resources Inc, Las Vegas, NV 12/04-2/08 o Acquired by Drayton-Richdale, Temecula CA 6/05, name changed to Coleman Scientific. President. o Managed development of patents and intellectual property, achieved sale of company to a publicly traded entity. o Served on the board of directors of Drayton and Petro/Biofuels subsidiaries Petrostrata and Cenocore to 2/08 o 40X increase in stock price during my board tenure attributed largely to my adding IP to company portfolio and finding previously unrecognized value in held assets.

Coleman Brothers Technical, Murrieta CA 4/94-

o Suspended business in non-compete agreement with employer “Foliage Software” 5/13, restarted 8/14 after Altran acquisition of and separation from Foliage. o Multiple Clients:

o Providing Finite Element Analysis, Computational Fluid Dynamics, Mechanical Design, product development and prototype services, and Expert Witness services, Patents granted and pending, multiple industries.

o Design and manufacture of precision miniature metal bellows, components for passive infrared devices and Joule Tompson cryostats, electroformed heat exchangers, and others. o Providing medical device design, analysis and regulatory functions for disposable and capital equipment for multiple now released products and/or acquired companies including Medegen (acquired by Cardinal Health), American International Technologies (acquired by Ushio) Carefusion, Neuropace, and others. o Leading Edge Engineering, San Diego CA. Consultant, 8/96- 12/19 o FEA and Medical Device specialist for technical services Company. Accomplishments include use of FEA and CFD to prevail in multimillion dollar lawsuit and create safer more durable power plant structure. See company website.

o Ketiv Technologies, Fullerton CA. 3/11-

o FEA (Finite Element Analysis) instructor and applications consultant to leading software vendor specializing in mechanical design and analysis.

o Rider and Mechanic, Coleman Brothers Racing Team 2/93-12/04 o Earned expert Motorcycle road Racing license 1996 at Willow Springs Iternational raceway o Rider and mechanic for road race team that was points leader at various times in some classes. o Raced in modern and "vintage" classes, used FEA and CFD techniques to analyze and optimize motorcycle frame and suspension dynamics and two cyle engine efficiency. Education

Bachelor of Science, Mechanical Engineering: State University of NY at Buffalo. Attended on an earned Regents Scholarship. Team member “U.B. Student Ultralight Aircraft Altitude Record” and “Human Powered Vehicle" teams.

Other training: Biomechanics, Project Management, Finite Element Analysis (ALGOR, now Autodesk Mechanical Simulation, ANSYS with Motion), Computational Fluid Dynamics (Blue Ridge Numerics CFDesign, now Autodesk CFD), Manufacturing Statistics, Design of Experiments, Medical Device Regulations, Geometric Dimensioning and Tolerancing (GD&T). Expert Motorcycle Road Racing License earned at Willow Springs 1996, retired from motorsports 2004 as part of DRYN board member performance contract obligations. Experienced ocean and Great Lakes sailor, experienced machinist and mechanic.

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