Medical Device Customer Service

David F. Sutton

*** *** **** **.

Shelton, CT ***84

Cell 203-***-**** Fax 203-***-****

*********@*********.***

Executive who leverages leadership expertise working in the

engineering/manufacturing capacity from startup through product launches.

Strong track record in leading and organizing SCM (Supply Chain Management)

coordinating R&D product development, QA/QC, and operations, with

technology and project management to build a strong world-class

organization. Key contributor in achieving corporate revenue, profit,

quality and performance objectives.

Broad base of experience in DFM (Design For Manufacturing) mechanical

design and production management for medical and industrial applications

displaying knowledge of materials, modeling, and manufacturing in the

fields of surgical, diagnostic, and analytical disciplines.

Roles included establishment of FMEA (Failure Mode Effects Analysis)

communications between product development, operations, and third party

manufacturers as the products moved toward commercialization.

Utilize a broad base of manufacturing processes inherent with diversified

experience working with numerous medical and consumer products companies.

Coordinated and involved the six sigma and lean manufacturing team to

address product issues CAPA (Corrective Action Preventive Action) and

administer various system information and updates necessary to maintain

quality documentation and cost reduction benefits.

Utilized STAR (Strategic Activity Review) to attain product excellence in

instrument manufacturing. Developed and administered operating & capital

budgets, cost containment, and strategic planning to achieve business

objectives.

Goal

To continue developing productive, cost effective medical devices,

instruments, and systems of high value in the medical market place.

Selected Career Achievements

* Founder - Chimaera Inc. Medical device design, prototyping, and

pre-production company.

* Co-Founder - Insight Technologies Ophthalmic medical device

company for Lasik Surgery

* Developed novel and patented microkeratome corneal surgical knife

Patent # 6,610,075

* Founder - 3D-Zine LLC Medical device design and manufacturing

consulting company.

Professional Experience

Manufacturing Engineering Director

Spine Wave, Inc. www.spinewave.com 2007 - 2009

. Function leader responsible for defining and developing

manufacturing processes for new products.

. Coordinate manufacturing process requirements, manage vendors, and

troubleshoot production.

. Assist in design for manufacturability, select appropriate

processes, equipment, and vendors

. Establish and document manufacturing processes for new products.

. Follow products from prototype development through cost reduction

programs.

Achievements and Credits Spinal Implant Projects

> Spinal fixation: Pedicle screw and cross-connector

> Vertebral fracture: FX product line - inter-vertebral

> Vertebral fusion: XD product line - intra-vertebral

President/Founder

3D-Zine LLC 2004 - 2007

Achievements and Medical Device Projects

> Cordis: Suture needles

> St Jude: Catheter design

> Joining Technologies: Laser fixturing and production processes -

Lean manufacturing

> Orchid Design: Spinal augmentation devices

President/Owner

Chimaera, Inc. 1984 - 2004

Chartered new company which was formed to design, prototype, and

manufacture pre-production medical devices used in surgical,

analytical, and diagnostic applications.

Operations grew to a staff of 30 occupying a 12,000-square foot

facility and generating over $3M in annual revenue. Qualified QC

operation to meet FDA compliance for GMP & ISO 2000.

Led and supervised the management team, manufacturing, research and

development, and operations.

Initiated programs in cost containment, and strategic planning.

Achievements and Medical Device Projects

> Davis & Geck - Managed design and fabrication of laparoscopic

instruments - Prestige Line

> Boston Scientific - Stent tooling & laser welding

> Nitinol Medical - Developed prototype stents and tooling, laser

welding fixtures

> Analytica - Manufactured prototype and production components for

Mass Spectrometers

> C.R.Bard - Redesigned and manufactured stent tooling (cost

reduction)

> Joint Medical - Aided in design of oblong hip cup - manufactured

hip and knee implants

> Synthes - Manufactured spinal implants

> Datascope - Produced micro-instrument components

Partner/Co-Founder

Insight Technologies, LLC 1997 - 2000

. Co-founder of company which invented and produced a microkeratome

for the medical market.

. Responsible for designing, research and development, field trials,

cost containment, and strategic planning.

Lead project team in development of new microkeratome (corneal

surgical knife) for Lasik eye surgery.

Supervised the project and design team for integrating the systems

electrical and mechanical components.

. Interfaced with customer service, manufacturing, RA/QA, client

surgeons and marketing to set product requirements.

Achievements and Medical Device Projects

> Developed novel and patented microkeratome - corneal surgical

knife: Patent # 6,610,075

> Integrated hardware with electrical console for exact motor control

> Santen (Japan) - customer support: Microkeratome device and Lasik

procedure

> Becton Dickinson - customer support Microkeratome device and

disposable blades for Lasik

Product Development Lab Manager

ACMI - American Cystoscope Makers, Inc. 1980 - 1984

A medical device manufacturer of fiber optics and

laparoscopic surgical instrumentation.

Managed a staff of 12 toolmakers and modelmakers

Developed state-of-the-art percutanious instrumentation with

optical delivery devices.

Worked in conjunction with R&D engineering to build and test

instruments.

Attended trade shows to assess products and provided technical

support for sales & marketing.

Integrated the product with manufacturing to hand-off methods

and procedures for production.

Research and Development Model Maker

Bic Pen inc. 1972

- 1980

International manufacturer of writing instruments, cigarette

lighters, and personal shaving instruments.

11 Worked as an extension of the engineering department

12 Create, build, and integrate new high-speed assembly machines into the

production assembly lines.

13 Updated and improved walking beam technology

14 Pioneered continuous motion principles into the production process.

DFSutton 3 of 3

Operating Systems: Applications:

Windows NT / XP SolidWorks versions 1997-2009: 3D Solid Modeling

MasterCam 9.2 - CNC 3D Machining

Education:

Norwalk Community Technical College - BS/ME Electro-mechanical

engineering

Sacred Heart University, Bridgeport, CT & Stamford, CT - Business and

Marketing

. University of Bridgeport, Bridgeport, CT - Industrial Design

Skills:

Toolmaker - Apprenticed @ Moore Special Tool, Bpt., CT

Model maker - Perkin-Elmer, Norwalk, CT

. Mold maker - Bic Pen, Milford, CT

. R&D Model maker - Bic Pen

. CNC Programmer

Operating Systems:

. Windows XP

. Microsoft Office

Applications:

. SolidWorks versions 1997-2008: 3D Solid Modeling

. MasterCam - CNC 3D Machining

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