Project Management

Jeffrey W. Perkins, PE

* ***** ****, ******, ** *4850 . 603-***-****

*/**/*****-*

E-Mail: ****.*******@********.***

AREAS OF EXPERTISE

OPERATIONS & STRATEGIC PLANNING

PROJECT MANAGEMENT

ENGINEERING LEADERSHIP EXECUTIVE TEAM

BUILDING P&L

PROFILE

Accomplished technology executive with a proven track record of leadership

and successful management of complex and difficult engineering programs. A

broad business background with over 20 years' experience in engineering,

manufacturing and operations of medium sized as well as startup companies,

Experienced in medical device / software diagnostic products and industrial

product development, release to manufacturing, and product introduction.

Strengths include; leadership, problem solving, simultaneous management of

large number of responsibilities, alignment of team goals with profit

objectives (KPI), committed to quality and measurable results, people

networking, technical ability, program and resource management, business

development, knowledge developing and delivering medical and industrial

hardware products as well as commercial software products. Programs under

my leadership are consistently right the first time, completed early or on

time and on or under budget.

ENGINEERING / OPERATIONS MANAGEMENT EXPERTISE

. Managing Director, Engineering / Operations of a successful Contract

Engineering Service company. Primary focus; Medical, R&D, Automation /

Instrumentation and Commercial Software development for over 13 years.

Background in upstream business development and market strategy, new

product conception, development and product commercialization.

. Lead of cross-functional engineering staff through full lifecycle

product development, providing leadership, planning and execution,

supporting regulatory, quality and product services including design

for manufacturability.

. Hands-on support and key driving force of all facets of the

engineering development process, including hardware, commercial

software, and manufacturing. Test and quality management control of

products to FDA/HIPAA, U/L, CE, CSA and SFDA. Critical guidelines for

Class II and Class III products utilizing 60601 and 62304. FDA

analysis of potential failure modes, Device Exemption Requests and PMA

/ 510(k) submissions with and without human use data. Full utilization

of FDA Design Control principals applying web based documentation

tools.

. Initiating and managing startup operations; technology and business

environment assessment, Software and Hardware engineering & production

teams and organization building. Implementation of strategic and

tactical plans, verify and validate designs, utilize phase gate /

tollgate management techniques, track projects with "Earned Value"

management tools with periodic re-assessments of business model.

Perform constant gap analysis between strategy and execution.

. Empowers and evaluates professional staff; maintains open channels of

communication to stimulate optimum delivery of service and positive

working environment.

. Provides ongoing guidance, utilizing developed negotiation, emotional

intelligence and conflict resolution skills.

. Develops and maintains positive relationships with key vendors and

customers with frequent visits to Asia, Japan and the UK. High level

sales management and downstream dealer/distributor management.

. Consults with management and staff to define business opportunities

and identify areas where technologies could enhance operations and/or

delivery of client services and products.

. Managed several development / R&D programs with multi-million dollar

engineering budgets, demonstrating high level of business achievement

managing profit and loss the majority of professional career.

. Utilizes leading edge or emerging technologies to Six Sigma quality

and Current Good Manufacturing Practice (CGMP), Utilize failure modes

and effects analysis (FMEA & FMECA) for analysis of potential failure

modes. Optimized Stage Gate process, achieving major improvements and

significant gain in productivity, profitability and manufacturability

(IQ-OQ-PQ) (DFM & DFT).

. Served as expert witness in several patent infringement and product

liability cases and hold seven US patents.

SELECTED ACHIEVEMENTS

. Designed and implemented a Laptop based system for diagnosis of

congenital cardiac disease. The system included ultrasound, spirometer

in addition to internal temperature and pulse oximetry to assist

telemedicine examination of heart and lungs. This project for the

Eastern Quebec Telemedicine Network (operational in 2000) required

full commercial software development including medical informatics,

information systems and electronic patient records (HL7 open source)

utilizing Big Data sets to determine quality of research and prevent

diseases. It was being revered as the first mobile e-health system. In

2010 the EQTN I was asked if we could apply across multiple machines.

Hadoop was investigated, however yet to be implemented.

. Designed and implemented an arterial tonometry device. Our design

goal was met when intra-arterial blood pressures were simultaneously

measured in either the right or the left radial artery with a cannula

and the tonometric monitoring on the contralateral radial artery,

showing the outputs of the tonometry measurement waveform nearly

identical to the waveform recorded intraarterially. This product

design and clinical trials lead to a successful product launch.

. Setup operations in China to design and release to production a high

level IP security product implementing several alarm protocols, IP

cameras including cellular delivery and backup.

. Designed and brought through clinical trials a Patient Controlled

Analgesic (PCA) {Class III} infusion therapy pump. This device was

designed for hospital use and included several standard therapies with

full doctor / patient security. This pump was designed with dual

voting processors and full control of both Basal and Bolus drug

dosages.

PROFESSIONAL EXPERIENCE / ACCOMPLISHMENTS

Transonic Systems Inc. - Ithaca, NY

Director of Engineering 10/10

Present

Report to the President/CEO and work closely with other functional leaders

in the company, including those in finance, sales, and marketing.

Responsibility included all of the company's R&D and product development

activities. The company designs and sells Transit-Time Ultrasound, Thermal

Dilution and Laser Doppler flowmetry for diagnostic blood flow sensing with

custom DICOM output. In addition, ECMO products (This technology assures

extracorporeal membrane oxygenation is adequate in neonatal intensive

care); proactive vascular access managed in hemodialysis clinics as well as

intraoperative flow measurements diagnosing and confirming cardiac and

vascular surgeon's clinical observations.

. Develop strategic planning, direction and control of product

development activities, e.g. a multichannel biotelemetry system for

advanced cardiovascular hemodynamic diagnostic measurements. System

designed to provide physiological measurements i.e. implantable,

multichannel biotelemetry system for measurement of blood flow,

pressure, ECG, and temperature in animal species such as dogs, pigs

and rabbits with minimal experimenter intervention after implant.

. Provide R&D technical direction and guidance, as well as hands-on

project management, for all product development.

. Ensure the optimal application of technology and engineering resources

to meet product development and/or customer requirements, per the

product and/or marketing requirements.

. Ensure that the product is fully and correctly defined and documented.

. Hire and direct staff of senior group members and directors to acquire

necessary resources and plan to meet scheduled commitments.

. Ensure implementation of formal processes to support the product

development process.

CryoMedix - Albuquerque, NM

Director Regulatory and Clinical Affairs

4/09 - 10/10

CryoMedix is currently a start-up. Set up Operations to facilitate Design

Rules, History Documentation, Use Case and Risk Analysis for new

CryoAblation Product. Implemented quality procedures to move forward with

510(k) submission. Worked closely with principals to facilitate fund

raising.

Sherwood Engineering - El Paso, TX

Engineering Manager and Operations liaison

9/08 - 10/10

Responsible for all aspects of software, embedded, electrical and

mechanical industrial design and release to manufacturing for all in-house

projects. Successfully managed manufacturing operation of a large pilot

program with a major Cable company.

. Implemented a full duplex audio radio utilizing Zigbee mesh

technology for a patient monitoring system. This system supported

full patient control to request help in the case of a medical

emergency. The system placed a phone call to 911 or care giver

allowing the user audio access to the supporting party with just a

small pendant worn around the neck.

. Designed and implemented digital IP camera and recording system

with full integration with medical patient monitoring system.

System also supported SMS and cellular alarm delivery.

. Design of several industrial, pump and motion control systems and

several consumer electronic products.

. Designed a frequency "cognitive" agile Cable fault detector

utilizing first-order predicate logic.. An integrated GPS logged

all events for subsequent service calls with CouchDB application,

this application was written in Java and JavaScript.

LaserShield Systems - Las Cruces, NM

VP Engineering / New Product Development

10/05 - 9/08

Responsible for growing new business units, engineering management of new

designs, and new product introductions. Successfully set up operations in

China to design and release to production of a high level security product

designed for international markets. The milestones were met on time and

the product contributed 10% of Q1 revenue and 34% of Q2. Established

processes and procedures that greatly increased both the efficiency of

product development as well as greatly improving ability to meet milestones

on schedule. Established OEM partnership program and signed a major

cellular alarm reporting deal.

. Designed and implemented an IP alarm controller supporting CID,

Ademco Fast, Multi pulse and several other protocols. Alarm board

supported MPEG-4, G.711, SIP RTP and POE with IP cameras, data

encryption, PIR, glass break detector, 412 MHz digital radio, and

GPRS cellular backup. .

. Established business relationships and negotiated contract with

third party, formulating a partnership allowing support for

cellular alarm reporting.

Instrumental in moving product into international markets through

homologation certification and NOM compliance.

EnerLogic Systems Inc. - Amherst, NH

Managing Director, Engineering / Operations (Co-founder)

4/92 - 10/95

Developed the first intelligent home automation system, (ES1400). This

system was fully programmable yet stand-alone. The system utilized

technology I developed and licensed to Heath . Project scope in

collaboration with clients, developed into a full building power control

and security system with networked CCTV system, customizable energy

reports, real time data monitoring, intelligent temperature control based

on occupancy and present temperature need, economizer control, electrical

demand limiting as well as other features such as IP cameras, motion

detection, card key entry, scheduled and Artificial Intelligence based

heating, ventilation, cooling and lighting control. Sold the patents and

licenses' to Performa Home Systems. Subsequently the product rights were

sold to Crestron Electronics Inc.

Circuit Research Corporation - Amherst, NH

VP Engineering / CTO (Co-founder) 7/92

- 10/05

Responsible for initial client contact, review voice of customer, design

project scope with collaboration with client, develop full-scale project

plans and communicate project expectations to client and team members.

Estimate resources and participants needed to achieve project goals.

Continually manage project expectations with team members. Plan and

schedule project timelines / milestones using appropriate project

management tools. Define project success criteria and disseminate them to

involved parties throughout project life cycle. Conduct project post

mortems and create recommendations report in order to identify successful

and unsuccessful project elements.

Medical Devices

CR Bard / Lowell MA

. Developed several infusion therapy pumps including a hospital

targeted PCA and an ambulatory infusion pump. Most pumps required

dual microprocessor designs with color LCD display and FDA approved

voting techniques. Required generating all FDA support documents

including, risk analysis and V&V documents to ISO13485, testing to

UL / IEC60601-1.

Therex Corporation / Walpole MA

. Designed IV, Polyurethane PICC, midline, thermal and balloon /

dilatation catheters supporting ureteric and anticoagulant-coated

e.g. DES stents reducing restenosis.

. Intrathecal Pump Implant (Spinal Pain Pump) utilizing catheters

designed for delivery.

Bard Electrophysiology / Covington GA

. Thermal ablation catheter intended for thermal ablation of the

uterine cavity and cauterizing of the endometrial tissue including

design of disposable. This system required extreme control of

pressure and temperature. Required generating all FDA support

documents, risk analysis and V&V documents including testing to UL

/ IEC60601-1.

Carmel Biotechnology / Haifa Israel

. Supported efforts for the design, manufacture and clinical trials /

PMA of implantable drug delivery pump for chronic back pain using

catheters for delivery. Designed implantable glucose sensors and

ultrasound transdermal delivery system of insulin through an RF

hand held device.

A.L.I Technologies Inc. / Richmond BC

. Designed general examination camera to support telemedicine

diagnostic physical examination. System included built-in LED light

source with control to assist in perceived brightness (photopic

control) and magnification. An Ophthalmoscope was also developed as

part of the family of devices. This system was designed to make it

possible for the distant examiner to see the tympanic membrane of

the patient's heart, lung and abdominal sounds using signal

processing providing DICOM output. The IT part of the system was

commercial software developed to focus on and provide insurance

carriers, self-funded groups and associations with a custom mobile

telemedicine service (e-health) providing their members access to

physicians 24/7.

Whitaker Foundation. / Waltham MA

. Designed analog and digital interface test equipment for the

development of continuous glucose monitoring system "implantable

enzymatic sensors" (pre trial) "testing with rabbits".

. Designed system for testing biosensors for measuring metabolites in

biological fluids. This was research funded by several universities

and government agencies, sponsored by Whitaker.

. Designed two devices to measure blood pressure. The first was a

mobile automatic sphygmomanometer utilizing multiple MEM's to

filter for the Korotkoff, canceling any other cuff sounds. - The

second was utilizing licensed technology to build a tonometer for

hospital applications. This system called arterial tonometry is a

technique for taking a blood-pressure measurement using an array of

analog pressure sensors pressed against the skin over an artery.

Minnetronix / St Paul MN for CardiacAssist, Inc.

. Contracted team developer of an extracorporeal centrifugal pump and

controller supported by a cannula inserted in the femoral vein.

This device was used to "unload" the left side of the heart. The

controller maintained pump drive control, air bubble detection an

IV and infusion system.

MedCool / Wellesley MA

. Designed the controls for a Therapeutic Hypothermia Device. This

system required critical control of time, temperature, fluid flow

and pressure while administering therapy to patient. The product

required several disposable designs. Guided this product through

clinical trials in the UK.

Automation/Semiconductor/Instrumentation

Walchem Corporation - Holliston MA

. Designed and implemented Industrial Water treatment Controllers

utilizing embedded web server with fax support and unique

"shoulder tap" technology to facilitate low cost access to remote

instrumentation through both 10/100T / Wi-Fi and SCADA services for

further trend analysis. A wide range of direct sensor measurements

were supported including; pH, ORP, Conductivity, Free Chlorine,

Chlorine Dioxide, Ozone and Peracetic Acid.

Pneumercator / Long Island NY

. Designed liquid level inventory management systems based on

microprocessor control and dual float magnetostrictive level probes

with integrated video monitoring IP cameras for truck filling

depots.

Systems installed using SCADA techniques with direct reporting

to SQL database to

support distribution and retail petroleum tank farms, chemical

processing, marine,

transportation and military customers.

Ferrofluidics Corporation / Nashua NH (Kayex)

. Designed Controls for a CZ Furnace to grow polycrystalline silicon

into singular crystal ingots.

This included power controls for drawing billet, the design of a

specialized line scan camera and optics to "watch" the melt in the

crucible to solidify accurately using the meniscus as a guide.

Extrion Corporation / Gloucester/ MA

. On design and management team to design, build, install and train

the Ion Implantation equipment. Included; Ion source (generate

Plasma from RF excitation) using arsine, phosphine, boron

trifluoride GAS, High vacuum; utilizing Roughing Pumps and Cryo

Pumps (10-2 --- 10-3 Torr), power controller of large electro

magnet to bend the ion beam, beam scanner, wafer handler.

High Voltage; ability to work with 200 - 400 KEV terminal voltages.

Lasergraphic Systems / Sudbury MA

. Design of 3 different laser systems to produce Laser Engravable

newspaper plates. This

included a HeNe laser, PMT and optics to scan the paste-up, an

Argon laser with a separate

set of optics and scanner to etch the metal coating on the

plate showing the image and a CO2

laser with optics and galvanometer driving a mirror to oblate

the polymer material allowing

relief for the image.

Crystalonics / Cambridge MA

Calibration engineer, Manager of department (on contract).

Boutique: semiconductor company.- 8" wafers

Famous for their collection of JAN (military) devices, Varactors,

JFETS, custom Hybrid microcircuits and dual / quad transistor

arrays.

Worked extensively with photo-masks, spin tables, diffusion ovens,

vapor deposition, photo resist. thin film deposition, probed and

diced dies, argon fluoride lasers and xenon lamps.

Handled the calibration of all test equipment, i.e. probe tester,

curve trace analyzers, scopes, meters, profile recorders etc.

Thermo Electron / Bedford MA (MIE Inc.)

. Designed and supported manufacturing of the personalDataRam dual-

chamber diaphragm pump providing volumetric flow sensing and

microprocessor control, allowing precision constant flow rate

control of +/-2% to perform particle size selective measurements in

active particulate monitoring applications. Design required power

supply for use in multiple countries as well as battery support.

Navigation Technology - Amherst NH

Engineering Director / Operations Manager (Co-founder)

2/90 - 4/92

. Co-founded Navigation Technology Corp. Developed one of the first

microprocessor based LORAN 'C' receivers for Military and

commercial use. Built the business to over 3 M in less than 3 years

and subsequently sold the product rights and 4 patents to Raytheon

Marine Co.

Other clients

. Bard Medical, DEKA, Rockwell / Conexant, Honeywell, Polaroid, GES-

Singapore, Digital Equipment, Image Data, Baxter, GE, Microcom,

Kayex,

TECHNICAL EXPERTISE

SOFTWARE: C/C++/C# . VB . JAVA . Python . Ruby . HTML .

Assembly . RTOS

Nucleus . INtime . MQX . MySQL. Couch

DB . agile . VectorCAST

HARDWARE: Cx51 . PIC . Z8X . 68X . ARM . MIPS . PPC . DSP .

CPLD . FPGA

ASIC . MSP430 . X86 . C166 . LM3Sx .

K50/60 . ARM

MECHANICAL: Plastic Injection molding / extrusion . Manufacturing

. Model shop . PCB

AutoCAD . SolidWORKS

ENVIRONMENT: Pads . LabView. Altium . IAR . P-Spice . OrCAD . ALTERA

. Xilinx

DISCIPLINES: Analog . Video . PLC . Telephony (SIP-VoIP).

Motor Control . Wireless . Cellular

Embedded microcontroller design . Industrial Control .

IP Lan/Wan, HART Modbus . Medical "Fail Safe Design" .

IrD . Fax and Data Communications

EDUCATION & AFFILIATIONS

Education

. Masters of Science : Computer Science - Northeastern University,

Boston, MA

. Bachelors of Science : Electrical Engineering - Syracuse University,

Syracuse, NY

Attended on an IBM service retention scholarship

. Certificate: Regulatory Compliance - Hood College, Frederick,

Maryland

. Certificate: Business Management - The Drucker Institute, Claremont

Graduate University, CA

Affiliations

. Member of the Experimental Aircraft Association (EAA)

. Member of the International Aerobatics Club (IAC)

. Senior Member of Institute of Electrical and Electronics Engineers

(IEEE)

Licenses

. Registered professional engineer (PE) - New York (status inactive)

. Private pilot / former Flight instructor, Aerobatics

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