SUMMARY: Over **+ years of Manufacturing experience ranging from Defense related industrial products to Medical Devices. Experience has included senior level research and development, manufacturing engineering positions with large international organizations and also has included executive level product development, corporate sales and marketing positions with healthcare start-up companies with extensive experience in program management and design engineering of medical devices and systems.

Proven leader, with a wide range of experience identifying market and business opportunities, solving problems and implementing appropriate business strategies to maximize performance and profitability.

Inventor or co-inventor on five U.S. Patents for Medical Devices used in the market today.

Highly motivated and results-oriented professional possessing exceptional communication skills. Proven skills in both direct and distributor sales. Professionally persistent in accomplishing goals and persuading others

Responsible for directly calling on Cardiovascular, Vascular, Thoracic, General, Orthopedic and Neurological Surgeons.

Demonstrates ability to positively impact corporate performance and competitive product positioning through effective account management. Utilizes strong background in team leadership and motivation to maximize sales efforts.

Sales Targets 118 % to plan for Year 2013-2014

Sales Targets 115 % to plan for Year 2014-2015

Areas of Expertise:

Establishment and leadership of multidisciplinary product development teams from requirements definition and product conception through manufacturing and product launch.

Establishment and management of internal Quality System Regulation

Expertise bringing complex technology products to market quickly, safely and cost effectively.

Development and presentation of materials for sales force technical training and sales force strategies.

Establishment and management of corporate intellectual property portfolio.

Hands-on engineering and fabrication of medical devices.

Selection and supervision of contractors and consultants for custom medical device design and fabrication, injection mold tooling, software development, and industrial design.

Facilitation of manufacturing & engineering transition to outside contractors.

Technical evaluation of new product acquisition opportunities to develop recommendations for executive management and Board of Directors.

EMPLOYMENT:

Vikon Surgical LLC. 4/1/12 to Present

Birmingham AL

General Manager

Responsible for managing both the revenue and cost elements of the company's income statement. Oversaw all the firm's Sales and Marketing functions as well as the day-to-day operations of the business. Responsible for effective planning, delegating, coordinating, staffing, organizing, and decision making to attain desirable profit making results.

Lead and trained Direct Sales team in the field and OR.

Negotiated agreements with key partners in optical design, mechanical design, battery system suppliers, and contract manufacturers.

Vice President, Products

Lead the development of a portfolio of medical devices and related products in efforts to build a platform of technology and products that would support sales goals and board directives based on current market research.

Developed a strong team of product owners and designers, sales force professionals ( both Direct and Special Distribution) and manufacturers.

Vikon under my direction developed a series of new medical devices; I developed multiple first “proof of concept” prototypes for demonstration to investors and boards of directors.

Director of Operational Services

Managed Production Schedule, Supply Chain Procurement, Quality Assurance/Control, Inventory, Assembly/Manufacturing, Repair and Technical Support for the Vikon Division. Used discretion and independent judgment to fulfill essential duties & responsibilities.

Responsible for QSR establishment, implementation and maintenance; and selection/supervision of operational support staff and contract manufacturers.

Integrated Medical Systems (IMS) 7/11 to 4/1/12

Birmingham, AL

Wedge Manufacturing Division/Production Manager

Shift Manager of CNC/Manual set up and production machinist

Assisted recently with order processing, process engineer, supplier management and resource allocation activities for production manufacturing at Wedge.

Represented Wedge during last BSI audit and wrote and implemented procedures and processes to ensure ISO and procedural compliance was met based on the audit findings and internal gap analysis.

Wrote and executed a Gage R&R Study to satisfy recently required aerospace customer QSR requirements.

BioHorizons Implant Systems/Biolok International Inc. 12/05 to 7/11

Birmingham AL / Ft. Lauderdale FL

Senior Manufacturing Engineer

Responsible for relocation and validation of the BioLok manufacturing facility to Birmingham. (Site allocation/development/relocation/implementation)

Process Validation Team Leader (PVTL) lead multi departmental team in validation activities including but not limited to Installation, Operational, and Performance Qualifications for Implant manufacturing process

Designed and managed development and validation of Manufacturing Production Machining Area and Sterile/Non-Sterile Clean room packaging areas

Developed and wrote manufacturing procedures, work instructions for Manufacturing and Sterile/Non-Sterile clean packaging areas and equipment, environmental monitoring procedures for Manufacturing and Sterile/Non-Sterile clean packaging areas and equipment.

Developed and wrote Device labeling and packaging procedures for Sterile/Non-Sterile products and components.

Corrective and Preventive Action Review Board Member

Managed all CAPA activities related to manufacturing.

Manufacturing Engineering Representative for the Change Control Board (CCB); Reviewed and approved document change request with respect to procedural and regulatory requirements; specializing in process validation, manufacturing/inspection process, design changes, device labeling

Preventative Maintenance Coordinator

Lockout/Tag-out Administrator

Wrote and revised standard operating procedures, work instructions, and forms for continuous improvement of the quality system

Manufacturing representative for Failure Mode and Effects Analysis projects (FMEA)

Responsible for all aspects of MFG with regard to FDA, ISO regulations

Overseeing quoting, programming, process controls, tooling crib

Scheduling, budgeting and long term project planning, new projects and Capital expenditures

Otis Technologies 2/05 to 11/05

Lyons Falls NY

Technical Support Manager

Overseeing quoting, programming, process control, research and development, tooling crib,

Scheduling, vendor expedites, customer service, shipping/receiving

Machine and building maintenance

Precision Systems Manufacturing Inc. 6/01 to 11/04

4855 Executive Drive

Liverpool NY 13088

Production Manager/+Technical Support Manager

Overseeing quoting, programming, process control, tooling crib,

Wrote and revised standard operating procedures, work instructions, and forms for continuous improvement of the quality system

Scheduling, vendor expedites, customer service, shipping/receiving,

Managed all manufacturing NCR activities to ensure root cause is determined and process correction/modification are made as required to prevent re-occurrence.

Machine and building maintenance, in charge of 40 + employees

CAD/CAM Programmer

CNC/Manual set up and production machinist

The Eraser Company, INC. 8/00 to 4/01

PO Box 4961 Olivia Drive

Syracuse NY

CNC Programmer/Machinist

Programming of CNC turning centers and vertical milling machines

Setting up of production and non-production jobs on both CNC and manual machinery

Otis Technologies 2/05 to 11/05

Lyons Falls NY

Technical Support Manager

Overseeing quoting, programming, process control, research and development, tooling crib,

Scheduling, vendor expedites, customer service, shipping/receiving

Machine and building maintenance

R & A Machine Tool 10/95 to 4/00

Rome NY 13440

Production supervisor, CNC programmer/operator

Production scheduling

Programming of CNC turning centers, vertical milling machines

Set-up production, non-production jobs on CNC and manual machinery

Preventative maintenance/breakdown management.

The Tool Room 5/89- 10/95 (Family Owned since 1978 )

Ava, NY 13303

Breakdown repair Machinist/Welder

Programming of CNC turning centers, vertical milling machines

Set-up production, non-production jobs on CNC and manual machinery

Preventative maintenance/breakdown management.

EDUCATION: High School completed (Adirondack Central, Boonville NY)

2 year Lean Manufacturing Institute Certification (Onondaga Community College, Syracuse NY)

Additional Skills:

Trained and proficient in all aspects of ISO9000-9001; ISO 13485; CFR 21 Part 820

AS9100, ITAR, DFAS

Trained and proficient in Product and Process Validation (IQ,OQ,PQ), PFMEA, PPAP, AQPQ, etc.

Proficient in with LEAN Mfg, JIT, experience with Six Sigma

Always ready for challenges/ Motivated and dillegent

Skilled with many different MRP and inventory systems

Computer-MS office professional, Excel, XP, etc.

Trained in CAD/CAM with 20 years hands on experience

Proficient with Geopath, Master Cam, CapsL and Vega Mill software’s

15 years of management experience with crew of 8 to 40+ people

Utilize Computer Numerical Controlled (CNC) or conventional production equipment per drawing, router, and any other ancillary written instructions. Responsible for setting up the machine(s), getting tooling in working order, passing first article inspections, passing in process part inspections, and making acceptable parts in accordance with applicable governing procedures.

References: Available upon request.

Contact this candidate