David Neklason

510-***-**** aco6sl@r.postjobfree.com

HTTP://WWW.LINKEDIN.COM/PUB/DAVE-NEKLASON/7/481/B

Senior Mechanical Design ENGINEER

Product Development design professional with extensive experience bringing

devices from concept through development and manufacturing then into the

international medical, scientific and industrial markets.

. Savvy, proactive team leader and Project Manager accomplished in guiding

diverse departments, disciplines and personalities towards common

objectives.

. Experienced in testing for and implementing CE requirements into existing

products and new design. Proficient in ISO and CE compliance as well as

FDA required design control procedures relating to medical products.

. Skilled in design and reliability test protocol definition and execution,

manufacturing process definition, and interfacing with Service,

Marketing, and Sales in the development of documentation relating to

those departments.

Fiber Optics Mechanical Design Prototype Testing

Medical Devices Opto-Mechanical Design Product Testing

Systems Integration Laser Systems Autodesk Inventor

Project Management Injection Molding SolidWorks 2012

Project Documentation Manufacturing Support Creo 2.0

Sustaining Engineering ISO/GMP DFx

KEY ACCOMPLISHMENTS

. $1.5M revenue generated per year on over 500 OEM units shipped after

mechanical, thermal and packaging design and Project Management of green

laser photocoagulator used in Bausch and Lomb's Millennium Surgical

suite.

. 10% reduction in COGS of entire product line by developing retrofit

assembly that relieved manufacturing of a single-source critical

component issue.

. 18% part count reduction in next generation IR laser head, including

integration of high precision adjustments into the optical bench machine

part.

. 4 major and countless minor projects and products released to the market

during my employment at Iridex. Instrumental in reintroducing the yellow

wavelength laser to ophthalmology after a 20-year hiatus.

WORK HISTORY

Consultant, Iridex Corporation, Mountain View, CA

2013 - 2014

Regulatory Compliance. Evaluated materials for compliance to Directive

2011/65/EU RoHS 2 and revised or created documentation to replace

non-compliant material and finishes on mechanical components, PCBs, PCBAs,

optics and labeling. Required evaluating over 800 components in 24 ECOs.

Additional tasks included incoming QA on first article components,

evaluation of compliance to internal SOPs and vendor management.

Staff Engineer, Iridex Corporation, Mountain View, CA

1999 - 2012

Systems integration, opto-mechanical design, console design, sheet metal,

injection molded components and fascia, and the development of all

manufacturing procedures and tooling for IQ577 laser console. This

console design has been the basis of several console products released by

Iridex Corporation in the last few years.

Designed, developed, tested and deployed disposable and reusable optical

delivery devices. Supported biocompatibility testing at external labs.

Project management and lead designer for the repackaging and system

upgrade of an existing product for use in otolaryngology.

Manufacturing documentation, training, support and engineering during

initial release of new systems, assemblies and components, saving

significant time in manufacturing spin-up and relieving the manufacturing

engineering staff of the added workload in implementing new procedures.

Design, development and deployment of incoming/receiving test fixtures

including integration of electronic and software features.

Design and development of manufacturing test and alignment fixtures,

including integration of electronic and software features.

Responsible for continuous follow up on all manufacturing, quality and

service issues. Where necessary, design and develop appropriate solutions

for increased reliability and durability of the laser devices. "Once its

Daddy, always its Daddy."

Experienced in ISTA testing of packaged products.

Responsible for the design, fabrication, assembly, IQ/OQ/PQ and operation

of prototype design and manufacturing test fixtures.

Liaison to Engineering, Quality and Regulatory groups to revise SOP's to

include provisions for ISO 14971 (2007) and IEC 60601-1 3rd ed. from the

product development perspective.

Mechanical Design Engineer, Continuum, Santa Clara, CA

1991 - 1999

Design, develop and bring to manufacturing flash lamp pumped and DPSS

laser components and systems for medical, research and industrial

applications.

Design and development of delivery devices for use in dental and

aesthetics laser systems.

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EDUCATION

De Anza College, Cupertino, CA A.S., CAD (Mechanical)

San Jose State University, San B.A., History

Jose, CA

Ohlone College, Fremont, CA A.A., Liberal Arts

Student, De Anza College, Cupertino, CA,

2012 - 2013

. Upgraded and enhanced CAD skills in SolidWorks and PTC Creo. Classes

include sheet metal and surfaces, advanced productivity in both platforms

and has resulted in certification for Autodesk, SolidWorks and PTC Creo.

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