Owen Clive Roberts

***** ********* ***** ********, **, 49071 U.S.A.

Cell Phone: 214-***-**** Email: l8p20l@r.postjobfree.com

PROFESSIONAL PROFILE

Dynamic and goal-oriented Senior Manager with well-honed technical and organizational skills

Highly skilled and flexible Project Manager, in both Single Programmes and Overall Product Strategies

Extremely experienced Project Engineer with a detailed knowledge of Product Design, Development and Regulatory processes through Qualification to Production in the Medical Device Industry

Very articulate and confident communicator with refined interpersonal skills

Enjoys being part of a successful and productive team and willing to take personal responsibility for the positive completion of goals

OBJECTIVE

To obtain a senior R&D or Product Development Management position within the Medical Device Industry that will make the best use of existing skills and experience while allowing for further personal and professional growth.

EXPERIENCE

20 Years Engineering and Management experience in roles of increasing responsibility

13 years Product Development Leadership – including Regulatory and Quality focus

Executive level budgetary experience and extensive supplier cost negotiations

More than 25 Successful Commercial Products designed and developed using a variety of materials and processes – over 100 full prototypes developed through tooling

Over 10 years of Product Portfolio Management responsibility – both Strategic and IP

Comprehensive communication and presentation experience to a wide variety of audiences

CAREER SUMMARY

Stryker Instruments, NSE 2009-Present

Platform Development Manager, R&D

• Responsible for all High Speed Drill Product Development – 10 direct staff and 3 indirect

• Directed Teams developing: a) Otology & Neurology Drill Systems ; b) Pedicle Screw Driver; c) Surgical Simulator; d) LED Light ; e) Bone Cleaner

• Analyzed all Regulatory Body Requirements for New Product Releases (510(k), MDD, MD, 60601 3rd Ed. etc.) as well reviewing present products for compliance to new requirements

• Instituted Product Road-mapping Strategy for responsible Product Areas

• Developed 2011 and 2012 budgets for all NSE Product Development Projects

• Consulted on development of Business Process Maps in the areas of Research and PDEV

• Acted as Subject Matter Expert in the streamlining of the Supplier PPAP process

• Attended Gallup Great Managers Program and AAMI/FDA Quality System Classes

Adams Golf 2004-2009

Director, Advanced Product Research 2007-2009

• Directed all Testing and Product Research operations with 7 direct staff – improved test efficiency by over 30%.

• Enhanced the Prototype Production and Testing processes through improved CAD design, Rapid Prototyping and use of Expert Consultants and Testing Facilities

• Managed all Intellectual Property and Regulatory Body Conformance Submissions

• Oversaw Acquisition of a New Testing Facility

Senior Design Engineer 2004-2007

• Chief Engineer and Project Manager for 6 major product releases in 3 years

• Responsible for timely delivery of products – over 90% on-time delivery

• Directed CAD design of products from a six person CAD pool - Unigraphics CAD

• Introduced new IP system – increased Patent Applications by over 100%

• Developed Supplier Evaluation Procedures and Qualification Standards

CAREER SUMMARY – continued

Callaway Golf 1996-2004

Manager, Advanced Technology 2003-2004

• Ten direct staff, ranging from Staff Engineers to Technical Specialists

• Oversaw prototype development and incorporation of new testing equipment

• Successfully completed Six Sigma Green Belt and Voice of Consumer Projects

• Continued as R&D Intellectual Property Portfolio and Conformance Manager

• Oversaw implementation of Six Sigma in 200+ employee R&D group

Manager, R&D Operations and Administration 2001-2003

• Coordinated $30 MM+ annual budget - reduced expenditure $2.7 MM+ (2002-2003)

• Developed new Technical Career Ladders for all R&D positions – technique chosen for use throughout organization

• Managed restructuring of R&D Staff (220 staff) to streamline R&D processes

• Reported directly to Senior Vice President

• Organized Six Sigma training, assignments and resources for all R&D staff

• R&D Intellectual Property Portfolio Manager - over 100 patents granted in 2002

Assistant Manager of Golf Club R&D 1999-2001

• Responsible for all Regulatory Body Conformance Submissions

• Led team tasked with major Facility Improvement to reduce building needs

• Managed R&D Intellectual Property (IP) Portfolio – introduced Patent Review

• Prepared all initial Product Release Information for presentation to Sales Staff

Senior Research Engineer 1998-1999

• Designed, prototyped and produced new test equipment and methods

• Provided expert support for all Marketing literature and Sales Conferences

Shaft Engineering Specialist 1996-1998

• Commercialized Composite Shaft Designs for 6 Product Lines

• Analyzed supplier processes to improve quality while preserving performance

Titleist and Foot-Joy Worldwide 1993-1996

Golf Club Design Engineer

• Lead Engineer on all composite and rubber components for commercial products

• Ordered, Installed and Commissioned New Testing Robot

• Initiated and Incorporated new Integrated Quality Procedures with Suppliers

VSEL 1985-1991

Business Analyst / Project Team Manager

• Headed Analysis, Development and Production of Reporting Capabilities for new Computational Accounting Software system – efficiencies saved over £150,000

EDUCATION

MS in Biomedical Engineering, Tulane University, New Orleans 1991-1993

4.0 GPA – Thesis on Cellular Adhesion to Biomaterials

BEng in Mechanical Engineering, Imperial College, University of London 1986-1990

1st Class Honours – Research on Artificial Ligaments

PROFESSIONAL COURSES AND SOCIETIES

Project Management, George Washington University 2011

Quality System Requirements and Industry Practice, AAMI 2009

Intellectual Property Management, University of California, San Diego 2003

Advanced Applications of MS Project, San Diego 2001

Member of Nexxus – Scottish Life Sciences Society

Member of Tulane Biomedical Association

Member of Tau Beta Pi Honours Society

Member of Alpha Eta Mu Beta Honours Society

OF INTEREST

EU Citizenship with US Green Card – Willing to relocate

REFERENCES

Available on Request

PUBLICATIONS

1. Bundy, O’Connor, Roberts and Sosa, “Cell / Biomaterial Adherence Measured with the Micro-Jet Impingement Technique”, 11th Southern Biomedical Engineering Conference, Memphis, Oct. 2-4, 1992, Digest of Papers, PP. 91-92

2. Bundy, Rahn, O’Connor, Roberts and Gerber, “Cell Adherence to Biomaterials of Varying Surface Characteristics”, Trans. 19th Annual Meeting of the Society of Biomaterials, Birmingham, Apr. 28 - May 2, 1993, P. 248

3. O’Connor, Roberts, Bundy and McLeod, “Strength of Cellular Adherence to Specific Biomaterial Surfaces”, Proc. 12th Southern Biomedical Engineering Conference, New Orleans, April 2 - 4, 1993, PP. 257-259.

4. Bundy, Roberts, O’Connor, Rahn and McLeod, “Quantification of Fibroblast Adhesion to Biomaterials using a Fluid Mechanics Approach”, (full manuscript of reference 4) Journal of Material Science: Materials in Medicine, 5, 1994, PP. 500 – 502

5. Chou and Roberts, “Golf Shaft Flex Point - An Analysis of Measurement Techniques”, Science and Golf II, Proc. of the 1994 World Scientific Congress of Golf

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