ROMAN N. TUNKEL

e-mail: acn7ie@r.postjobfree.com

cell: 617-***-****

FIELD OF EXPERTISE:

R&D of Medical Devices and Systems.

EXPERIENCE

****- ********* ********* *********** ********

-2014 BiogenIdec, Cambridge, MA

Provide technical oversight of device partners for BiogenIdec and lead the technology transfer efforts of new combination

drug products with devices into internal or external drug product manufacturing sites, from clinical development through

registration and commercial support

Supervise team of project engineers in the creation, evolution and use of designs and hardware for drug delivery

devices (autoinjectors-pumps), their associated test equipment, new device manufacturing process technology

demonstrators, precision measurement systems and other such equipment.

Create design solutions from conceptual designs to full production level detail design.

Provide technical analysis of designs for function and robustness by means of Computer Aided Engineering

(CAE) or traditional means.

Analyze designs for function, assembly, manufacturability, etc. using both CAE and traditional Engineering

techniques.

Leading the efforts for exploratory animal studies for drug delivery devices development.

Work and manage key interfaces and line functions in manufacturing, quality assurance and regulatory to

progress device development deliverables

2008- Staff R&D Engineer

-2012 BD Medical, Billerica, MA

Duties included acting as a lead for the R&D mechanical engineering team on assignments involving several people:

Conducting research and development of drug delivery devices for a variety of medical applications.

Participating in design efforts for infusion sets, SC and ID delivery, by providing technical solutions and

specifications for parameters.

Leading the efforts for the bench testing during the drug delivery devices development. Developed multiple tests

methods and capability for characterization of the infusion technology, that included tests for:

micro infusion sets for intradermal delivery;

o

characterization of the infusion pumps;

o

insulin potency, occlusion and degradation with mechanical agitation;

o

infusion sets for sub-q delivery, by including applicable standard procedures and novel test methods;

o

dose accuracy of the drug delivery devices, including insulin infusion pumps;

o

prefilled and used filled reservoirs of the drug delivery devices;

o

break out and gliding forces of the infusion pump cartridge's (for material selection);

o

Developing mathematical model of infusion sets, including effects of pressure pulsations and temperature

dependant size changes and time relaxation of the components.

Developing of FEA model of cannula accurately predicting the force’s level as input to physical tests.

Developing the human skin bench model for use in demonstrating of intradermal/subcutaneous injections.

Identifying new opportunities based on field research and exposure to current and emerging clinical procedure

and device technologies.

Contributing in brainstorming meetings, generation and processing of technical reports, presentations and

submission of disclosures as appropriate.

Constantly scouting/identifying technologies that have potential to provide differentiation to infusion platform

such as new materials, processing, testing and design techniques.

2007- Lead Mechanical Engineer

-2008 General Electric Healthcare, Lawrence, MA

Duties included act as a lead for the mechanical engineering team on assignments involving several people:

Participated in all phases of the product development lifecycle from design prototype to design transfer;

Technical lead in mechanical design on a cross-functional team through all stages of product development.

Provided technical support to other mechanical engineers within the engineering department;

Developed design requirements on system / subsystem level, procedures and tests plans for medical tools;

Participated as a team member in feasibility studies of electromagnetic tracking system;

Lead mechanical design effort on new technology;

2004- Sr. R&D Mechanical Engineer

-2007 Boston Scientific, Watertown, MA

Duties included research, analysis and development of new concepts of products and processes, as well as interaction with

customers and suppliers:

Conducted research and development of complex single use medical devices for a variety of medical

applications.

Performed analysis/modeling of hydraulic and electro-mechanical systems supported by test data to quantify

design parameters as required to support the commercialization product specifications.

Performed fluidic analysis for peristaltic pump, for fluidic channels with steady flow and with flow obstacles, for

suction (vacuum) line of air-water mixture for creation of product specs, and design changes recommendations.

Developed an infrared tracking system to improve angular measurement accuracy of the flexible tip of the

endoscope.

Participated as a team member in feasibility studies during proof of concept of a new electromagnetic imaging

system to view the entire endoscope at all times during a medical procedure.

Identified new opportunities based on field research and exposure to current and emerging clinical procedure and

device technologies.

Conducted research and investigation of interaction of colonoscope with simulated mechanical human colon

model and 3D Human Torso Model, including design & development of instrumented simulated Colon Model

with multi-channel data acquisition systems and collecting data of doctor / model interaction during simulation

of procedure.

Contributed in brainstorming meetings, generation and processing of technical reports, presentations and

submission of disclosures as appropriate.

2003- Sr. R&D Mechanical Engineer

-2004 BioValve Technology Inc., Worcester, MA

Duties included design, analysis and development of new concepts of products and processes, as well as interaction

with customers and suppliers:

Designed and developed linear insulin pumps with springs actuation (Pro-E, MathCad).

Designed and developed a non contact, high pressure (up to 15,000 psi) needless fluid jet delivery systems.

Developed experimental techniques for measurement of low pressure and high viscous fluid flow.

Utilized design of experiment method, conducted an investigation of the ultra high viscosity flow of fluids.

Conducted theoretical and experimental investigation of creeping in spring system.

Prepared technical reports, and presentations.

1999- Software Engineer,

-2002 Raytheon Inc., SEL, Marlborough, MA

Duties included developing software for communication device, modeling for a variety of IT applications:

Conducted thermal analysis of electronic rack and shelter "Alaska" (MIL-810, Mathcad, Pro-E).

Conducted modal analysis for X gantry. Investigated / validated vibration (Matlab, MathCad).

1998- Research Engineer, United Technologies Corp.,

-1999 Mechatronic Systems Division, Research Center, E. Hartford, CT

Duties included analysis and modeling, as well as research, development and design of actuator system for a variety

of applications, centered on control technology programs in the following areas:

Analyzed dynamic of both mechanical and fluid flow models, used as starting point for design.

Investigated acoustic non-linear model of fuel feed system dynamics (MatLab, FemLab, Simulink).

Investigated Effect of valve oscillations on mass flow through injector with different pipe length.

Developed actuation systems, using piezocrystalic materials as drivers for flow and combustion instabilities control.

Provided technical input for proposals for both internal and external funding.

Provided periodic reports and presentation material for selected reviews.

1995- Sr. Research Engineer, INGERSOLL-RAND,

-1998 Water Jet Systems, Farmington Hills, MI

Duties included design, analysis, as well as research and development of new concepts, products, and processes in

area of ultra high-pressure (up to 75,000 psi) waterjet cutting system and components:

Utilizing DOE method (polynomial, multifactorial) and FEA software (ALGOR) performed material selection and

design optimization of ultra high pressure components including polymer based seals;

Conducted experimental and theoretical investigation of the temperature field distribution in high-pressure elements

and cooling systems (MathCad, Matlab, ALGOR);

Conducted experimental and theoretical investigation of pressure drop for high pressure line elements - vessels,

cylinders, elbows, valves, swivels, etc;

Designed the double-action hydraulic intensifier elements: vessels, cylinders, valves etc. (AutoCAD);

Designed the feedback control systems of linear hydraulic pump and double-intensifier;

Developed experimental techniques for measurement pressure, water flow and temperature;

Developed vacuum sensor for AWJ nozzle (LabTech Notebook, LabView);

Developed experimental techniques for testing the pump's noise / vibration characteristics;

Performed structural and fatigue testing of high pressure components;

COMPUTER SKILLS

FEA: MES Algor, Comsol;

Design: SolidWorks, Pro-E;

Analysis and Modeling: MathCad, Matlab, Simulink;

DAS: WinWedge, Labview, Keithley etc.

PATENTS

Multiple Russian patents

Multiple US patents

EDUCATION

BS in EE, Department of Electrical Engineering, LMU, St. Petersburg, Russia/USSR.

MS in ME, Department of Mechanical Engineering, LMU, St. Petersburg, Russia/USSR.

Advanced Studies of Math Certificate (MS in Math), LSU, St. Petersburg, Russia/USSR.

PhD in ME, Institute of Machine Design, Moscow, Russia/USSR

PERSONAL DATA

US citizen.

Secret clearance (non-active).

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