James Lestienne

D anvers, MA *****

( ***) * 93 - 2431

c accool@r.postjobfree.com

Summary: I am a dynamic, entrepreneurial, and innovative technical professional with a very strong

and broad technical background. I have successful experience across a wide range of project and

program management types and challenges. This includes the ability to see the big picture of projects

and strategic business objectives combined with the ingenuity and technical ability to accomplish tactical,

time-sensitive aspects.

I am successful and comfortable in providing practical leadership and direction to global, multi-disciplined

engineering, technical and cross-functional business teams developing innovative solutions for a variety

of industries. I have broad and thorough knowledge of engineering and operations theory and principles,

including R&D, quality, manufacturing, supply chain, NPI, design and sustaining engineering.

Professional Work Experience

Sensitech (a United Technologies Company) Oct 2011 to present

Design Assurance Manager

Establish and implement design assurance into processes and organizational mindset. Apply a strong

background in Systems Engineering, NPI, Reliability Engineering, V&V, hardware and software

engineering, system integration, and technical leadership to influence and direct cross-functional teams

while improving standard technical practices. Ensure high product quality, VOC, end-to-end system

performance, reliability, and manufacturability. Develop automation and test strategies; create new and

unique capabilities for test and qualification of products and systems. Liaison with life science and

strategic customers; manage and ensure high profile and special projects are successfully completed.

Thermo Fisher Scientific Apr 2011 to Oct 2011

Senior Product Engineering Manager

Direct all aspects of new product development, applications, and technology on assigned product lines.

Manage and lead multi-functional team s to develop and sustain products to meet customer requirements

and business targets. Utilize a technical understanding of electronics, instrumentation, software and

hardware along with a solid understanding of NPI, engineering and design processes. Manage and

direct all engineering, technical and manufacturing matters related to multiple assigned product lines.

Massachusetts Institute of Technology – Lincoln Laboratory Mar 2010 to Apr 2011

Senior System Developer

Participate in research and development of the most sensitive optical communications links ever created

for high-data-rate, interplanetary communication, and flight programs (NASA and Air Force sponsors).

Develop hardware and software for optical communication links, control and flight telemetry systems.

Design instrumentation and platforms (test beds) for optics, electro-optical and electronic hardware.

Lead advanced integration of automated data acquisition, instrumentation, control and telemetry solutions

for rapid laboratory demonstration and flight programs. System architecture and programming with

LabVIEW and MATLAB. Started and championed a LabVIEW User Group and established best practices

for systems engineering and software across groups and divisions at MIT-LL.

Pfizer Nov 2009 to Feb 2010

Subject Matter Expert - Compliance Engineering short-term consulting role

Plan and execute strategies for third-party agency product certification and regulatory approvals for global

and domestic markets. Direct and guide engineering departments for compliance to standards, directives

and market requirements. Incorporate compliance into the NPD, engineering and ECO/ECN processes

to improve technical practice. Perform hazard / risk analysis for mechanical, electrical, biological and

chemical hazards on large scale automated electro-mechanical and bio-mechanical equipment.

Invisar, Inc. Jan 2000 to Oct 2009

President

Manage programs and projects, supervise technical personnel, and operate a design services company

that provided new product development and product realization, systems integration, automated test

solutions, strategic innovation consulting, and highly skilled engineering services.

Product Design and Development: Actively and deeply involved in the design, engineering and

application of new products and technology. Provide complete, turn-key solutions and engineering

services to small and large client organizations in a variety of industries .

Successful experience with electronic, software, electro-mechanical systems, and mechanical design

integration. Ability to conceive, fabricate and demonstrate working proof-of-concept models and

prototypes for business and investment (venture capital) buy-in. NPI, advanced manufacturing and

global (EMS) contract manufacturer selection experience.

Accepted and active as a Microchip Design Partner, Microchip Medical Design Specialist, Atmel ARM

Design Consultant, TI Design Partner and TI RF Specialist.

System Integration: Architect, engineer and deploy specialized instrumentation, automated test,

SCADA, and custom automation systems for a variety of industries and applications. Capture and define

project and technical requirements in order to design and deploy complex, one-of-a-kind solutions with

critical performance criteria. Capital equipment solutions and planning ability.

A valued National Instruments’ VAR and Alliance Program member (2002 to 2009) and a trained system

integration, test, automation and LabVIEW development subject matter expert.

Architected and designed networking and enterprise solutions for remote monitoring, integrated control

and data acquisition, data storage, and statistical and process analysis.

Compliance Engineering: Planning and execution of strategies for third-party agency product

certification and conformity: UL, CSA, CE Mark, ISO, IEC 60601, DO-160, DO-254, etc. Perform and

lead requirements and design reviews, risk / hazard analysis. Interface with third party agencies and

laboratories. Manage product safety, EMI / EMC, environmental, FDA, and industry specific standards

compliance, submittals and conformity assessments.

V&V and Design Transfer: Planning and execution of product and process Verification and Validat ion

(strong V&V knowledge). Plan and execute IQ, OQ and PQ projects. Experience with design transfer

to production (including DFM, DFT, DFx, etc.), new product introduction ( NPI ), and reliability.

Business: Business owner involved in all aspects of business development. Strong B2B experience

developing and executing sales strategies, nurturing relationships, and closing new accounts.

Consultative selling experience with highly specialized technical solutions.

Ability to communicate and interact at all levels of a client organization (i.e. executive management,

project leaders, and technical gurus). Synthesize customer requirements and contractual needs into

successful solutions that acknowledge technical, schedule and cost constraints.

Successful experience includes preparation and presentation of proposals with heavy technical content.

Ability to conceive and propose viable solutions that align with client needs . Maintained active

memberships and leadership roles in industry organizations: Board of Directors NC Aerospace Alliance,

NC Medical Device Steering Committee, and member of NC-BIOTECH and industry standards

organizations.

Broadband Home Jun 2000 to Apr 2002

Development Engineer

Design of home networking and home automation products / systems. Develop reference electronic and

hardware designs to license technology to OEM customers (e.g. Microsoft, TiVo, Scientific Atlanta ).

Hill-Rom Oct 1997 to Jun 2000

Design Engineer

Design and development of emergency signaling, wireless locating, nurse call and communication

systems for healthcare facilities. Provide technical and training support to sales professionals and field

service project managers. Resolve complex technical and system issues in field with heavy interaction

with customer.

Design: Called upon by business and engineering management to provide leadership in all phases of

product design, from concept through manufacture, to ensure smooth transition into production. Product

engineering to include electronics, firmware, mechanical and overall system integration.

Select, establish and manage relationships with EMS manufacturing partners, critical component

suppliers, and contract design firms.

Compliance Engineering: Primary contact and managing engineer for all agency (UL, CSA, FCC, CE,

etc.) compliance, submittal, and approval activity. Researched applicable standards (safety, EMC and

environmental) and managed compliance engineering and certification test efforts for intended markets.

Participate in NEMA technical subcommittees and UL standards advisory groups.

Responsible for the CE marking and UL / CSA approval of critical hospital systems and data networks.

Test: Develop automated test systems utilizing LabVIEW, data acquisition, GPIB and instrument control

to support contract manufacturing partners.

Andersen Services Jul 1997 to Oct 1997

Engineer (contract / consulting position)

Provide technical direction for the design and manufacture of microprocessor based chemical (EtO)

sterilizers. Assist in the compilation of technical dossier for CE Mark and ISO registration.

Resolve electrical, mechanical and control system design issues. Identified and implemented new

features and design enhancements. Develop custom LabVIEW instrumentation and test soluti ons for

manufacturing test and data collection.

Respironics, Inc. Mar 1990 to Jul 1997

Engineering and Product Test Manager

Promoted quickly through manufacturing and engineering organizations becoming the managing focal

point for all Design Assurance activity.

Management: Managed an R&D laboratory, budget, facilities, and personnel (Test Engineers and

Technicians) in support of electronic, embedded software, and mechanical design and development

efforts. Developed strategies and planned all system integration, test and design assurance efforts,

ensuring compliance with quality system and regulatory requirements.

Verification and Validation: Responsible for the planning, development, execution, documentation and

analysis of hardware and software V&V programs. Authored corporate procedures and methods for V&V

and Design Control; conducted companywide training.

Compliance Engineering: Managed regulatory and agency (UL, CSA, FCC, IEC, FDA, CE, 510k, etc.)

compliance, submittal and approval efforts. Guided design and development teams, conducted

standards research and engineering reviews for international product safety, EMC and environmen tal

compliance. Interfaced with third party agencies and certifying bodies. Compiled technical and test data

for 510k.

Design and Development: Involved in all aspects of electrical, software, mechanical design and system

integration. Knowledge of product and requirements capture and definition, design control, design

transfer to production (including DFM, DFT, etc.) and new product introduction in medical device industry.

Test and Analysis: As Senior Engineering Technician, independently extracted, compiled, and analyzed

a variety of technical data using a myriad of test equipment and instruments . Planned, lead and

executed testing, analysis, modeling, prototyping, and debug of complex and experimental electronic and

electro-mechanical devices and integrated systems. Performed root cause failure analysis.

Manufacturing: As Electronic Test Technician, provided technical support to manufacturing operations.

Responsible for troubleshooting, repair, failure analysis, and calibration of complex elect ronic and electro-

mechanical equipment.

United States Air Force, First Tactical Fighter Wing Jun 1986 to Jan 1990

Integrated Avionics and Electronics Systems Specialist

Received professional military leadership training while expanding technical expertise and responsibilities

in the maintenance, theory and repair of fighter aircraft communication, navigation and electronic warfare

systems.

Training: Received extensive formal training in electronics theory and also in the theory, operati on, and

hands-on repair of complex avionics and electronics systems. Additional training in instrumentation,

electrical systems, environmental control, hydraulics and pneumatics, and electronic test equipment.

Awards and Honors: Received many awards and honors for technical and military abilities such as

Professional of the Year, First Tactical Fighter Wing (1988); Honor Graduate of formal electronics

courses; early promotion; and Specialist of the Month many times for the air wing.

Education, Training and Memberships:

University of Colorado, Professional Certificates in Computer Applications and Information

Technology and Novell Network Education and Administration.

Completed various National Instruments LabVIEW, Data Acquisition and Instrumentation

courses. Accepted and active as a National Instruments Alliance Member and Value-Add

Partner 2002 – 2009. Extensive training on data acquisition systems, LabVIEW, GPIB

instrumentation, PXI hardware, signal conditioning, laboratory automation, SCADA, and

project management.

Attended many accredited courses and formal workshops for a Certificate in Professional

Management, Mountain States Employers Council, Denver, Colorado.

Honor Graduate of United States Air Force, Electronics Theory and Advanced Principles

courses.

Completed industry courses in Software V&V, Process Validation, Reliability Assessment,

Design Control, Design of Experiments, GD&T, cGMP, GAMP ( GAMP 5 & 4 ), ISO,

21 CFR Part 11, and Risk / Hazard Assessment.

Community College of the Air Force, Electronics and Avionics Technology.

United States Air Force Integrated Avionics Systems (Communications, Navigation and

Electronic Warfare Systems) and Advanced Electronics courses.

Honor Graduate of United States Air Force courses in Technical Organization Management.

MIT waived requirements for PhD to recruit me for position at MIT Lincoln Laboratory.

Accepted and active as a Microchip Design Partner and Medical Design Specialist 2005 to

2009. Training on new microcontrollers, electronics, analog peripherals and system

architecture. Worked closely with Microchip corporate business unit leaders and market ing -

participated in joint marketing and sales campaigns, to include medical and life science

industry initiatives. Many successful designs completed for variety of applications.

CMMI training and experience

Accepted as Atmel AT91 ARM Design Consultant Specialist.

Accepted and active as a TI Design Specialist and RF Design Consultant for low power,

ISM band designs (i.e. 2.4 MHz, 900 MHz) - custom antenna, RF systems, and design

architecture.

Accepted and active as a Lantronix integration and value-add partner - networking, wireless

and communication technology equipment.

Issued patents and (pending) patent applications -- ability to conceive and describe

concepts and develop working prototypes for business investment.

Past and active memberships in industry organizations:.

o Board of Directors NC Aerospace Alliance

o NC Medical Device Steering Committee

o member of NC-BIO and other state business/industry organizations

o IEEE full membership and IEEE standards committees

o ISA distinguished member

o ISPE

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