James D. Ervin
Vice President of Product and Manufacturing at Wellsense, Inc.- Claim this Profile
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Bio
Experience
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Wellsense, Inc.
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Vice President of Product and Manufacturing
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Feb 2022 - Present
• Wellsense’s lead product, the VU, is a real-time pressure monitoring mat for preventing bedsores - Home (wellsensevu.com). The system informs caregivers about patient contact pressures to inform best-practice positioning while also continuously monitoring for changes in pressure when patients self-position. • Pressure injuries affect roughly 2.5M persons in the US annually, where treatment of these wounds adds a ~$10B annual burden on our health system. The main goal is to prevent pressure injuries - to prevent patients from having to endure lengthy and painful recovery from these wounds while also preventing roughly 60,000 fatalities per year. • I am blessed to work with such a mission-oriented and capable team! My role is to lead product design, manufacturing system design, manufacturing commissioning, quality system development, and support new product / new market development. • Medical Device cGMP Professional Certification - 21CFR Part 820 Training (BioPharma Institute)
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FlexSys, Inc.
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Ann Arbor, MI
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Technology Consultant
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Jan 2007 - Present
-> Established engineering methods, review, and documentation processes over technical programs -> “First in flight” contributor: first commercially viable shape-morphing wing technology -> Helped FlexSys deliver technical excellence to consumer partners including DOE, NASA, USAF, Boeing, Aston Martin, Magna, Steelcase, and others Joined FlexSys in 2007 to add expertise to multiple programs • External review to guide scope, methods, and quality of work • Product development support from scoping/planning through development/delivery for custom compliant mechanisms and actuation systems, including compliant structural systems • Led early project scoping, energy method feasibility studies, brainstorming and ranking efforts to prioritize development paths, analytical model development • Grants / proposals / technical writing / trade shows / program reviews / IP development FlexSys was formed over 20 years ago to create “compliant mechanisms”: “truss” like structures for complex motion tasks, designed using structural optimization, often with actuators driving motion. A main focus has been to develop shape morphing wings that can optimize contour for different flight tasks: fuel efficiency as mission conditions vary, expanded mission capability, fatigue reduction. Diverse project types: compliant wings - aircraft / wind energy / marine / auto, windshield wipers, amplified acoustic piezoelectric actuators, blast / crash absorbers, ballistic weapons, and medical devices.
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Inspire Rx, LLC
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Ann Arbor, MI
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Chief Technology Officer
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Aug 2020 - Feb 2022
-> Led team to complete designs on 3 products in 6 months with pipeline for other products -> Filed 2 products with FDA and awaiting emergency use authorization (EUA) for sale -> Company now has potential value > $10M / yr, possibly exceeding $100M / yr in pandemic times In six whirlwind months, I led the team to deliver on multiple medical device programs • Finalized “surgical tent” design with team and created two new “helmet” designs from scratch • Developed “low-volume-affordable” launch strategy with a vision for high volume cost-reduction • Identified key regulatory requirements, designed and executed numerous test protocols (e.g. nano-particle containment, filtration performance, flow, power, temperature, humidity, CO2, O2, dB) • Progressed patent portfolio on current and future products • Documented design and test activities to submit EUA’s on two products • Led equity discussions, developed manufacturing and customer partnerships, and led pipeline planning for future products to prepare the business for scale In early 2020, Inspire Rx was formed. With support from health leaders at the University of Michigan, Inspire Rx proposed "personal isolation systems" as a new means to fight Covid-19 The AerosolVE Tent and Helmet products control Covid-19 transmission at the source by filtering air at the point of exhale, as opposed to trying to filter room spaces faster than viral levels concentrate. Aerosolve (aerosolvedevices.com)
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Reven Pharmaceuticals
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United States
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Biotechnology Research
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1 - 100 Employee
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Chief Technology Officer
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Apr 2014 - Aug 2020
-> Led development effort to increase the company’s valuation from ~20M to >$7B in 6 years -> Technical voice supporting >$60M private equity raise over last 3 years -> Identified drug mode of action and led technical team to deliver FDA Phase II readiness Joined Reven’s FDA-path development team as a technical consultant in 2014 and rose quickly to lead pre-clinical development activities. Joined full-time in 2018 as CTO to lead Reven’s clinical development program • 6+ years of self-study in medicine: cellular processes, metabolism, tissue and electrolyte maintenance, cell signaling, acid-base physiology and cellular origins of disease • Defined Mode of Action (MOA): developed literature-informed theories and performed studies to define the MOA • Led technical team: formulation investigations, assay development, manufacturing methods, stability studies, scaling studies, test design, results interpretation, IP development, business value modeling, pipeline planning, and technical communication media • Technical lead for communications: FDA, shareholder, & equity settings • Technical lead for pre-clinical safety and efficacy studies and Investigational New Drug (IND) submission (5000+ pages) • Led successful "safety" Phase I human trial • Led preparation of Phase II trial for Critical Limb Ischemia (CLI on hold due to Covid-19) • Led team to pre-IND approval for Covid-19 Phase II trial • Handed off clinical development to Phase II experts in August 2020 (Trial Approved Oct 2020) Reven is developing RJX, an intravenous drug technology platform formulated to target areas of metabolic function, oxidative stress, and blood vessel control. RJX is believed to mimic various physiological aspects of physical exercise and in doing so, modulate the microenvironment in which cells interact with our bloodstream. Ultimately, this affects the microenvironment within cells themselves, to steadily condition cells towards wellness.
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MForesight: Alliance for Manufacturing Foresight
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United States
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Research Services
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1 - 100 Employee
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Delegate Representing Ford Motor Company
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Sep 2016 - Oct 2018
-> Positioned as leadership voice representing Ford future manufacturing policy interests while active as full-time Ford employee and consulting for Reven and FlexSys -> Engaged with industry and congressional leaders on matters of system economics and policy Served as the Ford Motor Company delegate to MForesight for over two years • I am proud to have represented the needs of Ford and shared ideas within the forum to ideally deliver improved competitiveness of U.S. based manufacturing in the years ahead MForesight is a policy think-tank organization whose mission is to lead a national conversation on factors affecting US sited manufacturing. The goal of the organization is to highlight gaps and enablers which can enhance US competitiveness in manufacturing including those regarding: workforce, emerging technology, access to equity, taxation, tariffs, IP infringement, currency manipulation, and data security.
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Ford Motor Company
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United States
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Motor Vehicle Manufacturing
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700 & Above Employee
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Technical Expert - Powertrain Systems Development, Six Sigma Black Belt
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Nov 2011 - Oct 2018
-> 20 years developing “first in industry” powertrain systems and methods -> Developed technology decision framework which has been adopted as a de-facto standard -> Received engineering excellence award for physics-based automated powertrain calibration and fuel economy accounting tools: Cut “cars and months” while improving FE 5-15% , Delivered potential value >$1B / yr -> Instead of driving for further management advancement during the economic downturn in 2007, I negotiated an allowance from Ford to consult for and advise “out of industry” start-up technology companiesSystems done right are a team sport! I was lucky to work with many brilliant minds at Ford on many rich problems, often to cumulate their efforts into the delivered result. My work at Ford was founded in a systems mindset: What is the system being optimized? Interfaces? Inputs? Outputs? How does it work? How can we control it? Tradeoffs? How much time and money for development? Gaps in our knowledge? Resources? Documentation? Processes? Models? Patents? What data is available? How do we work smarter? Ford: Technical Expert - Powertrain Systems Development, Six Sigma Black Belt• Powertrain Tools and Analysis Lead. Dec 12 - Oct 18: Coordinated global resources within multi-organization team to perform vehicle-level optimization of powertrain systems relative to NVH/Fuel Economy/Performance/Package tradeoffso Conceived and developed physics-base vehicle calibration optimization tool to cut months from the development cycle while enabling fuel improvements of 5-15%. (kernel for future adaptive / algorithmic shifting) o Conceived and developed analytical methods to regress fuel economy cycle data delivering near-instantaneous scorecard of loss opportunities. Substantial development time and quality impact.o Systems lead to transfer to future algorithmic shifting applications
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Technical Expert - Powertrain Systems Development, Six Sigma Black Belt
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Apr 1999 - Dec 2012
• Next-up Technology Development Lead, Jan 09 – Dec 12: workplans, specification, modeling, prototyping, and experimental test• Next-Up Technology Selection Lead, Nov 07 – Dec 12: Led expert teams to rank and recommend “next-up” technology landscape. • Lean Combustion Systems Lead, Jan 11 - Dec 11: Multi-organizational team for Lean Burn system with aftertreatment. Methods to project manage and optimize tradeoffs are a corporate case study for complex system development. • Cylinder Head Optimization Lead, Feb 09 - Oct 09: Developed rule-based analytical geometry toolsets to automate design • Vehicle Integration Lead for Electromagnetic Valve Actuation, Aug 05 - Oct 07: Electronically intensive engine program with 200+ sensors• Lead for External Actuator Assessment, Dec 04 - Aug 07: Identify design shortcomings and plans of action (modeling, prototyping, and test) for supplier development including IP / freedom to operate. • EVA Actuator Characterization, Dec 02 - Dec 04: Developed specification documents and methods.• Electromagnetic Valve Actuator (EVA) lab development, Nov 01 - Dec 02: Developed actuator test lab and data analysis methods. • Traction Drive Toroidal CVT, Apr 99 - Nov 01: Developed models for variator efficiency, torque capacity and contact stress. Trained as dyno operator and mapped engine settings. Devised and implemented "power based" control strategy. Conceived and patented novel "angular offset" hardware variant to increase roller count (evolved in NuVinci / Variglide technology). Technology Examples: Belt CVT, toroidal “traction drive” CVT, 6/8 speed AT, electromagnetic valve actuation, lean burn gasoline and aftertreatment, hydraulic and electric cam phasers, cam profile switching, cylinder deactivation, variable compression ratio, fuel injectors, advanced turbochargers, vacuum pumps, coatings, high-power electrical supplies, novel FEAD systems, novel cylinder head layouts, structural inserts, and novel block designs.
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BalaDyne Corporation
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Ann Arbor, MI
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Product Development Engineer
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Jun 1995 - Apr 1999
-> Transferred "first in market" electromagnetic balancer to aerospace partner Pratt & Whitney for Lockheed Martin F-22 Raptor program -> High-speed machine tool application variant sold to Lord Corp. in 2000 -> Led mechanical and magnetic design: novel design solutions and analytical methods were key to the programs’ success Mechanical design lead for automatic balancing of jet turbine aircraft engines while in-flight • Co-lead for the program alongside controls lead reporting to Chief Engineer • Structural design for active turbine engine balancing device: Developed first principle solid mechanics models, refined using FEA • High Speed Bearing Design: Developed analytical load limit and friction models for high load capacity under extreme centrifugal loading. Early use of ceramics • Compliant Mount Design: Designed concentric support to accommodate large radial growth (key to program success) • Magnetic Optimization: Defined optimal flux path using magnetic FEA. Fabricated prototypes and validated through testing. • Balancer Press Fit Design, Modeling: Developed analytical and FEA models for press fit of mixed-material concentric elements under unbalance / centrifugal / thermal / fatigue • Assembly: Determined optimal order of assembly with fixtures and methods (e.g. ovens, liquid nitrogen) In response to a request from Pratt & Whitney to support the F22 Raptor program, BalaDyne wanted to create a high-bandwidth stepper-motor based balancing system. The challenge was to actively balance aircraft engines in flight, with a goal to correct unbalances within 0.2 seconds as caused by a small munition strike or debris such as sand. Augmenting their existing low-bandwidth hydraulic-based technology... The high bandwidth system is believed to have been implemented in the F22 program Technology also spun-off for high-speed machining balancing (e.g. chip / debris on tooling)
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University of Michigan
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United States
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Higher Education
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700 & Above Employee
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Graduate Student Research Assistant
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Sep 1994 - Apr 1999
-> A founding member of the Smart Materials and Structures Design Laboratory-> Developed highest energy density architecture in its class of piezoelectric amplificationConducted research and development on multiple “first in industry” productsThesis Topic: Piezoelectric Strain-Amplifying Actuator Architectures, 9/94 – 4/99: • Defined mathematical basis to grade piezo-actuation technology and architectures by energy density• Identified new improved architecture, developed analytical models for quasi-static and dynamic performance, designed, fabricated, and tested prototype actuators to verify models• Established lab resources: fixturing, power supply, data acquisition, sensors / transducersActive Roller Bearing, 7/97 – 4/99. (Sponsored by Draper Laboratories, Cambridge, MA.): • Investigated piezo-actuators for active modulation of roller bearing load for satellites. Developed prototype design and transferred technologyMicro-fabrication of Electro-Ceramic Devices by Co-extrusion, 1/95 - 12/95: • Developed micro sensor / actuator fabrication process involving co-extrusion of metal and ceramic powders in a polymeric matrix capable of producing micro-devices with features as fine as 10m• Defined and managed extrusion and kiln equipment along with running scanning electron microscope to complete the project The Smart Materials and Structures Design Laboratory was founded to study smart materials like piezoelectrics, electrostrictives, and magnetostrictives, often to amplify their output as a key to many commercial applications. As actuators, these materials yield fast, yet small motions, with high force in response to voltage or magnetic fields (sensors: vice-versa). e.g., helicopter rotor-blade, satellite gyros.
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13 Semesters as Graduate Student Instructor
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Sep 1992 - May 1997
Mechanical Engineering and Applied Mechanics, University of Michigan, Ann Arbor MI-> Served as lead GSI over other GSI’s -> Always achieved high ranking (>4.48/5.00) on official instructor evaluationsMEAM 450, Mechanical Design II (Senior Capstone Design), W95 - F95: • Mentored / graded senior design groups through real-world projects: scoping, design, fab and testMEAM 250, Introduction to Design and Manufacturing (W96 - W97)• Taught and graded geometric modeling, CAM, and CAD/CAM, mentored design and fabrication projectsMEAM 101, Computer Aided Design (F92 - W94) • Taught, and graded technical drawing and CAD, wrote homework and exams for all sections Graduate Student Instructors are paid to augment the professorial staff at U of M.
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Kelsey Hayes Corporation
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Livonia, MI
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Consultant: Literature and Patent Review
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Jan 1997 - Nov 1997
-> Compiled and reviewed ~1000 literature and patent sources on the history and state of the art of Antilock Brake Systems to support litigation and defense, freedom to operate, and infringement I was hired to augment Kelsey’s legal team as I had familiarity with complex mechanisms and was experienced in journal and patent searching with University of Michigan library resources • Growth in IP experience: I learned the art of strong claim structures while growing to identify gaps in claim coverage, appreciate what concepts, features, and ideas are likely to be patentable, and how IP can affect commercial potential and liability Kelsey-Hayes was an early leader in anti-lock brake technology but had to navigate a minefield of litigation and patent right challenges as a consequence of being first to market.
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Inventor and IP Portfolio Manager - 1999 to present
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Jan 1997 - Jan 1997
• Methods and Compositions For Improving Outcomes of Cancer PatientsUS-2020390743-A1 Patent Filed Jun 12, 2020 • Compositions and Methods for the Treatment of Metabolic ConditionsUS-2020121640-A1 Patent Filed Oct 28, 2019• Method for controlling transitions in a variable displacement engineUS-10267222-B2 Patent Issued Apr 23, 2019• Selective surface porosity for cylinder bore linersUS-10180114-B1 Patent Issued Jan 15, 2019• Selective surface structure for terminalsDE-102018116666-A1 Patent Filed Jul 10, 2018• Twin scroll turbocharger in a variable displacement engineUS-9915194-B2 Patent Issued Mar 13, 2018• Method for controlling vibrations during transitions in a variable displacement engineUS-9874166-B2 Patent Issued Jan 23, 2018• Adjustable core turbochargerUS-9695822-B2 Patent Issued Jul 4, 2017• Variable displacement engine controlUS-9677479-B2 Patent Issued Jun 13, 2017• Dedicated EGR cylinder post combustion injectionUS-9534567-B2 Patent Issued Jan 3, 2017• Systems and methods for EGR controlUS-9534542-B2 Patent Issued Jan 3, 2017• Method for a variable displacement engineUS-9441551-B2 Patent Issued Sep 13, 2016• Compliant motion distribution systemUS-9322506-B2 Patent Issued Apr 26, 2016• Devices and methods for exhaust gas recirculation operation of an engineUS-9279393-B2 Patent Issued Mar 8, 2016• Trennwandeinsatz far einen verbrennungsmotorDE-102016102391-A1 Patent Issued Feb 11, 2016• Variable cam timing control during engine shut-down and start-upUS-9243569-B2 Patent Issued Jan 26, 2016• Hydraulic rolling cylinder deactivation systems and methodsUS-9217339-B2 Patent Issued Dec 22, 2015• Feed forward control for electric variable valve operationUS-9097146-B2 Patent Issued Aug 4, 2015• Bulkhead insert for an internal combustion engineUS-2016237946-A1 Patent Issued Feb 12, 2015• Adjustable core turbochargerUS-8840365-B2 Patent Issued Sep 23, 2014
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Inventor and IP Portfolio Manager - cont'd
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Jan 1997 - Jan 1997
• Variable valvetrain turbocharged engineUS-8833058-B2 Patent Issued Sep 16, 2014• Surface Vibration Using Compliant Mechanical AmplifierUS-2014306576-A1 Patent Filed Dec 19, 2013• Engine valve control system and methodUS-8132548-B2 Patent Issued Mar 13, 2012• Multi-function throttle valveUS-8056546-B2 Patent Issued Nov 15, 2011• Adjusting electrically actuated valve liftUS-7640899-B2 Patent Issued Jan 5, 2010• Active control surfaces for wind turbine bladesWO-2009061478-A1 Patent Filed Nov 6, 2008• Active control surfaces for wind turbine bladesUS-2010259046-A1 Patent Filed Nov 6, 2008• Engine valve control system and methodUS-7415950-B2 Patent Issued Aug 26, 2008• System and method for providing hydraulic valve lash compensation for electrically actuated internal combustion engine poppet valvesUS-2009266319-A1 Patent Filed Apr 28, 2008• Surface vibration using compliant mechanical amplifiersWO-2008127731-A1 Patent Filed Apr 14, 2008• Electronic valve actuator having hydraulic displacement amplifierUS-7314026-B2 Patent Issued Jan 1, 2008• Reducing power consumption and noise of electrically actuated valvesUS-7204210-B2 Patent Issued Apr 17, 2007• Adjusting valve lash for an engine with electrically actuated valvesUS-7165518-B2 Patent Issued Jan 23, 2007• Electronic valve actuator having vibration cancellationUS-6997433-B2 Patent Issued Feb 14, 2006• Reduction of power consumption and noise in electrically operated valvesDE-102006004576-A1 Patent Filed Feb 1, 2006• Setting the valve clearance in a motor with electrically operated valvesDE-102006003412-A1 Patent Filed Jan 24, 2006• Continuously variable traction drive with traction rollers having a caster angleUS-6866609-B2 Patent Issued Mar 15, 2005• Elektronischer Ventilstellantrieb mit VibrationstilgungDE-102005001487-A1 Patent Filed Jan 12, 2005• Traction-drive, continuously variable transmissionUS-6575869-B2 Patent Issued Jun 10, 2003
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Coltec Industries / Holley Automotive
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Warren, MI; Water Valley, MS
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10+ Management Development Rotations as Co-op and Post-Graduate Engineer
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Jun 1989 - Sep 1994
-> 1st mentor quit immediately after I hired as a co-op employee, leaving me to deliver on his responsibilities and provide engineering recommendations in first 3 months -> Subsequently placed into “management development rotation” program as a Co-op -> Over 10 developmental engineering positions in 5-year span Co-op (alternating semesters) and BSME graduate engineer in corporate and plant environments: Manufacturing Engineer (MS: 5-9/94, 5-9/93) and Co-op (MI: 10-11/90, 6-9/89, MS: 8-10/90) • 1st mentor quit leaving me to define effective retention means for spring and magnetic calibrations: identified pre-staking as preferred over post-staking, adhesive to earn managements trust • Conducted running overhaul, redesigned and implemented station design changes to high-volume automated transmission pressure regulator assembly line: improved uptime from 70% to >95% in 5 mos. • Launched & qualified transmission solenoid, throttle body and intake manifold lines including gauging • Designed & implemented pallet handling conveyor and lift bed with safety fool-proofing Research and Product Development Engineer - Co-op (MI: 5-9/91, 11/89-2/90) • Hydraulic solenoid optimization via experimental characterization: inductance, resistance, magnetic circuit, seat interface, and temperature, also machined and assembled precision components • Studied effects of methanol exposure on production throttle body components: designed test, fabricated apparatus, performed experiment in just 4 weeks to meet customer timing Quality Engineer (MS - 2/92-8/92) and Co-op (MI: 9/91-2/92, 5-6/90, MS: 6-8/90) • Quality plan development: process and material flow diagrams, FMEA's, gage plans, equipment validation and timing studies Holley Automotive, with design facilities in Warren, MI and manufacturing in Water Valley, MS, operated research, design, development, and manufacturing activities to supply vacuum modulators, throttle bodies, and transmission solenoids to the automotive industry.
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Education
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University of Michigan
Ph.D. ME, MSME, Mechanical Systems and Design -
Lawrence Technological University
BSME, Mechanical Engineering