ROGER EDENS

N950 Fox Run Lane #8, Oconomowoc, Wisconsin 53066

* (262) 490.7710 red2c9c4@westpost.net
PROFILE

Enthusiastic, seasoned, and dynamic professional, offering several

years of experience in manufacturing, research and development, and
product design involving electrical-mechanical medical devices.
Demonstrate keen expertise in establishing and implementing effective
strategies and plans to achieve solid business results as well as
tremendous product innovation and growth. Capable of managing
projects simultaneously while ensuring sensible completion. Acquired
proficiency in FDA and ISO standards and guidelines in the
development of manufacturing quality control documentations. Proven
effectiveness in determining client requirements and resolving
complex problems and business challenges through technical
innovation. Creative, results-driven and extremely able to multitask
in a fiercely competitive, fast-paced environment while maintaining
high ethical and quality standards, professional demeanor and
cooperative attitude. Seeking a challenging career as an Engineering
Manager or an Engineering Project Manager that would effectively
utilize outstanding work ethics, management skills and organizational
leadership.

QUALIFICATIONS SUMMARY

*
Extensive background in the development, implementation and
documentation of FDA GMP and ISO procedures and quality control
processes for product development, manufacturing and regulatory
requirements
*
Broad scope of product designs that met and passed the ISO/EN60601
and collateral medical safety standards
*
Expert at utilizing network and spectrum analyzers, oscilloscopes,
frequency counters and synthesizers, pulse and signal generators, and
noise figure and power meters
*
Demonstrated proficiency in utilizing metal lathes, mills, presses
and other mechanical prototyping machines
*
Competency in embedded micro-controller design and software
verification and validation processes
*
 Technical knowledge on the application of MS Office and Schematic
Capture programs; capable of utilizing and working effectively in
AutoCAD 2000; extensive knowledge and use of FMEA practices

PROFESSIONAL EXPERIENCE

Vascular Solutions Inc. * Minneapolis, MN

_Vascular Product Line purchased by Vascular Solutions_
LIAISON (BETWEEN ESCALON MEDICAL AND VASCULAR SOLUTIONS)
2010-PRESENT
*
Function effectively in handling the technological and manufacturing
transfer of the Vascular Access product line from Escalon to Vascular
Solutions
*
Demonstrate expertise in technology; ensure the provision of
educational training sessions to accelerate and alleviate transfer to
marketing, production and engineering
Escalon Vascular Access * New Berlin, WI
_Vascular Access Research and Development, Design and Manufacturing_
FACILITY AND ENGINEERING MANAGER
2003-2010
*
Ensured management of all facets of the New Berlin facility,
including development, manufacturing and distribution operations
*
Instrumental in driving business expansion from 2.0 million to 3.9
million, and producing over $50,000 in the annual savings through
executing redesign efforts, manufacturing improvements and process
controls
*
Prospected and built new strategic business relationships to advance
product development and tactical ventures
*
Utilized management skills in conducting research and development of
medical ultrasound devices and ophthalmic surgical instruments in
adherence to ISO 13485, FDA, CE, UL, and other regulatory
requirements
*
Handled and developed the research and development budget as well as
ensured maintenance and compliance of manufacturing principles and
schedules
Escalon Medical Corp * New Berlin, WI
_Ophthalmic and Vascular Design and Manufacturing Corporation_
ENGINEERING MANAGER
2000-2003
*
Conveyed new Vascular Access product line into facility; assumed
full responsibility in managing the technology transfer, design and
implementation of manufacturing processes
*
Ensured management and prioritization of electrical and mechanical
design projects from perception through production
*
Developed existing designs and translated new design concepts into
practical design specifications through interfacing with marketing
staff and customers
*
Strategically managed manufacturing operations to accommodate sales
demands
*
Advised on electrical mechanical medical designs; achieved three US
patents while processing fourth patent for submission
*
Chosen to participate in FDA Working Group of the Light Hazards Task
Force to develop safe operating parameters

Mortara Instruments * Milwaukee, WI

_Non Invasive Diagnostic Cardiology, EKG Equipment and Supplies_
ENGINEERING
1999-2000
*
Ensured conformance to ISO and FDA guidelines while developing EKG
peripheral devices
*
Executed maintenance of design records, files and procurement
materials
*
Provided assistance to the Manufacturing Department in addressing
difficult/abnormal failures, and developed troubleshooting practices
on newly developed product

EARLIER EXPERIENCE

Trek Medical Corp * Mukwonago, WI

ENGINEER
1992-2000
GE Medical Systems * Pewaukee, WI

ENGINEERING TECHNICIAN
1991-1992
Texas Instruments Incorporated * McKinney, TX

ENGINEERING TECHNICIAN
1987-1991
US Army, Sergeant E-5

ELECTRONIC TECHNICIAN
1983-1987

EDUCATION

BACHELOR OF SCIENCE IN ELECTRICAL ENGINEERING

Marquette University, Milwaukee, WI

ELECTRONIC TECHNOLOGY
Waukesha County Technical College, Waukesha, WI

ELECTRONIC TECHNOLOGY
Collin County Community College, McKinney, TX
ELECTRONIC DIPLOMA, HONOR GRADUATE
US Army, Ft. Bliss, El Paso, TX

TRAINING | SEMINARS

ENGINEERING DOCUMENTATION CONTROL University of Wisconsin,

Milwaukee, WI
FAILURE MODES EFFECTS ANALYSIS (FMEA) University of
Wisconsin, Madison, WI
IEC60601 STANDARD FOR SAFETY Underwriters Laboratories Inc.,
Northbrook, IL
MANAGING MULTIPLE PROJECTS, OBJECTIVES AND DEADLINES Skill
Path Inc., Milwaukee, WI
INTRODUCTION TO EUROPEAN SAFETY, EMC, AND MACHINERY TUV
Rheinlander, Cologne, Germany
DESIGNING FOR EMC Tektronix, Beaverton, OR
SOLDERING FOR ELECTRONICS Gateway Technical College, Kenosha,
WI
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