Speak to a world-class expert now.
1-800-FOR-KKAI (1-800-367-5524)
info@kkai.com
PrimeTrack® Instant Conferencing
PrimeTrack® Project Management System (patent pending)

LITIGATION SUPPORT SERVICES


CENTER FOR RAPID RESPONSE ENGINEERING® SOLUTIONS

ENGINEERING AND SCIENTIFIC CONSULTING SERVICES

Resume of DIW
Consultant

EXPERTISE AND SERVICES

Design Engineer, Electrical Engineer, Biomedical Engineer, Medical Device Product Developer, Engineer, Engineering Failure Analysis, Accident Reconstruction Consultant, Specialist, Forensic Analysis, Investigation, Product Liability, Expert Witness Testimony, Patent Infringement, Expert Witness Testimony, Engineering Consulting Services
Expertise in senior design engineering and project management, with over 20 years experience in full lifecycle medical device product development, from concept to commercialization; diverse background in all areas of biomedical, electrical, mechanical, and packaging engineering.

Additional areas of expertise include engineering team leadership, ISO 9000 design control, CE Mark requirements, domestic and European product safety testing standards, handheld disposables, resuables, microprocessor control instrumentation, and solid modeling.

This KKAI Associate also specializes in schematic capture techniques, design control, product specification, quality plan preparation, product testing, materials, safety, effectiveness, lifecycle, documentation, process development, process validation, and regulatory compliance.

Has conducted numerous studies in areas including implantable inserter, endoscopic instruments, destructive and life testing, instrument repair, electrosurgical safety boot, endoscopic dissectors, ultrasonic surgical aspirator product improvement, reusable, disposable endoscopic tissue grasping-dissection forceps, suction irrigators, microkeratomes systems, endoscopic instrument insulating connector, ultrasonic and electrosurgical energy combination

PRINCIPAL INDUSTRIES SERVED
Biomedical, Medical, Pharmaceutical

EDUCATION
B.S., Electrical Engineering and B.S., Biomedical Engineering, University of Bridgeport

AAMI Certified Clinical Engineer, Association for the Advancement of Medical Instrumentation Training, ISO 9000 Auditing, Crosby Quality Education System (QES), Statistical Process Control (SPC), MS Office, Project Management, Orcad Electronic Schematic Capture CAD, Solidworks Solid Modeling CAD

PROFESSIONAL EXPERIENCE
Consultant, Kevin Kennedy & Associates, Inc.

Providing project management, design engineering, electrical engineering, biomedical engineering, medical device product development, failure analysis, forensic engineering, consulting and related expertise for a wide variety of clients.

Speak to this experienced, world-class expert now.

For additional or different expertise, browse other top-level expert resumes in Expert Testimony, Failure Analysis, Manufacturing Optimization, KKAI's Center for Rapid Response Engineering® Solutions and a host of other Engineering and Scientific Consulting services.

Learn how KKAI assembles expert teams of any size or skill set combination to meet our clients' needs on a rapid-response basis - no matter how complex the challenge.

Or, peruse our 325 case studies or 475 other expert resumes.


Search Entire Rapid-Response Site
Search Resumes Only
Case Studies

Project Manager, Design Engineer, Electrical Engineer, Biomedical Engineer, Engineer, Failure Analysis, Forensic Engineer, Consultant, Expert

Provided clients with engineering management services, designed and developed medical device products including handheld disposables, resuables, and microprocessor control instrumentation utilizing solid modeling and schematic capture techniques. Managed all aspects of development projects, design control, product specification and quality plan preparation, product testing (materials, safety/effectiveness, lifecycle), and documentation. Developed and validated processes. Ensured compliance with regulations as well as 510(k) filing guidelines. Solved mechanical design problem with an implantable inserter for Restore Medical and managed new design of the device to reduce costs and increase profits. Established design control systems to enable numerous companies to obtain ISO 9000 certification.

Senior Project Engineer, Advanced Engineering, Endosurgery, Davis & Geck Inc.

Project manager for fast-track commercialization of new endoscopic instruments; ensured adherence to strict schedules, with time-to-market for a main platform set at ten months and line extensions at two months. Led technicians and engineers; prepared schedules for product development and testing, including destructive and life testing. Assessed OEM vendor capabilities to ensure alignment with the company's marketing plan. Established and directed technicians within an instrument repair department. Designed and patented an electrosurgical safety boot for use on endoscopic dissectors.

Senior Project Engineer, Research and Development, Valleylab, Inc.

Project manager responsible for launching new and improved ultrasonic surgical aspirator products to market utilizing a project team concept. Led the improvement of existing designs to increase reliability and profitability. Coordinated the release of over eight products that generated sales of over $35 million. Designed and implemented the disposable steam/ETO sterilizable product line and co-designed a steam/ETO sterilizable straight and angled handpiece as well as a switching mechanism.

ADDITIONAL EXPERIENCE

Orchestrated the release of over 200 products in two years for Davis & Geck Inc., including unique, high-quality 5mm/10mm reusable and disposable endoscopic tissue grasping-dissection forceps and suction irrigators that accounted for sales of over $25 million.

Repackaged disposable product line of Valleylab Inc. to drive profits through manufacturing cost reductions and improved customer appeal.

Managed and designed two microkeratomes systems for Becton Dickinson, achieving acceptance for CE Mark on both designs as well as new product entry into market.

PUBLICATIONS
Co-holder of patents for an endoscopic instrument insulating connector as well as a method of combining ultrasonic and electrosurgical energies.

Please note that this is an abbreviated CV. A fully detailed unabridged CV is available under special circumstances.

Click on the button above to request more information about this Associate.

Following are links to the resumes of a select few of many KKAI Consultants, Engineers and Experts with related expertise.

Review the resumes below, or enter your search query (type of expertise you are seeking) in the box below, choose to search the entire Rapid-Response site or just resumes, then click the search button. Please note that the list of resumes available online is a select subset of our vast database. If your search of our site does not reveal the expertise you are seeking, please call us toll-free (in the U.S.) at 1-800-367-5524 or contact us for more information and we will gladly assist you in locating the specific expertise you require.


Search Entire Rapid-Response Site
Search Resumes Only
Case Studies

Design Engineer, Electrical Engineer, Biomedical Engineer, Medical Device Product Developer, Engineer, Engineering Failure Analysis, Accident Reconstruction Consultant, Specialist, Forensic Analysis, Investigation, Product Liability, Expert Witness Testimony, Patent Infringement, Expert Witness Testimony, Engineering Consulting Services
Resume of HAH packaging engineer, packaging consultant, engineering consultant, engineering failure analysis, accident investigation, accident reconstruction, specialist, forensic analysis investigation expert, patent infringement, expert witness testimony, engineering consulting services
Resume of EFZ packaging engineer, protective packaging engineering consultant, engineering failure analysis, accident investigation, accident reconstruction, specialist, forensic analysis investigation expert witness testimony, engineering consulting services
Resume of LKU packaging development specialist, new product development consultant, packaging design consultant, research and development consultant, packaging technology expert, packaging engineer, expert consulting services
Resume of KPG biomedical design engineer, computational and experimental mechanics specialist, engineering failure analysis, accident investigation, accident reconstruction, forensic analysis investigation expert witness testimony, engineering consulting services
Resume of JMG mechanical engineer, engineering manager, product design and documentation, engineering consultant, fatigue failure analysis, accident investigation, accident reconstruction, specialist, forensic analysis, investigation, product liability, expert witness testimony,

Have an urgent litigation support or engineering and scientific consulting need? Contact KKAI now for world-class, expert rapid response.

1-800-FOR-KKAI (1-800-367-5524)
info@kkai.com

BACK TO THE TOP OF THIS PAGE
Kevin Kennedy & Associates, Inc.
Rapid Response Engineering® Solutions
3905 Vincennes Road, Suite 320
Indianapolis, Indiana 46268
(317) 536-7000 voice
(317) 536-7220 fax

SEARCH our site

Search Entire Site
Resumes Only
Case Studies

Our innovative, proprietary and patent-pending PrimeTrack® Rapid Response capabilities can help you quickly find the experts you are looking for.

Search here to examine any of the more than 475 resumes for KKAI lead consultants and associated experts from our global organization.

Simply enter the type of expertise you seek, and then choose to search the entire Rapid Response site, to just read resumes only, or to read any of KKAI's more than 325 case studies. A rapidly growing organization, KKAI adds more than 20 expert resumes and 40 expert case studies to its Web site each month, so check back often.

CALL US TODAY
Call KKAI with an urgent need. Experts are paged instantaneously and can be made available in a virtual conference room. To experience this unique capability, please call us at 1-800-FOR-KKAI (800-367-5524) from the United States or 317-536-7000 if calling internationally.