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Product Development Medical

Location:
Port Washington, Wisconsin, 53074, United States
Salary:
$80k/yr.
Posted:
August 29, 2017

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A product development leader that excels at identifying unmet needs to rapidly develop and commercialize profitable orthopedic devices. Outstanding track record of creating and commercializing market defining products, securing protection of intellectual property, and gaining regulatory approvals.

KEY ACCOMPLISHMENTS

Drove development of new products which allowed the growth of Titan Spine from around $1M annual sales to over $30M in 7 years.

Participated (on a team of 3) in achieving ISO 13485 certification of Titan Spine in 6 months.

Named as inventor on 38 United States Patents for medical devices.

Lead the development and launch of the Charlotte™ Foot and Ankle product line which is the foundation of the extremities business unit at Wright Medical today, a highly profitable extremities and biologics company.

Created an industry leading craniotomy device at OsteoMed that has been in use, for more than 15 years.

I have developed long term relationships with nearly all the service and support Vendor companies that serve the medical device marketplace.

EXPERIENCE

President and Principle Consultant Black Box Medical May 2007 – Current

Medical Device Consulting featuring significant experience in Design, Engineering, Commercialization, Intellectual Property and acquiring Permission to Market new and innovative medical devices.

Developed 3D printed metal implants and instruments for an easy to use foot and ankle product to complete joint repositioning and soft tissue attachment of the 1st MTP. Instruments were designed to combine several steps and they significantly cut down on surgery time and requires only one incision.

Researched, designed, submitted and received 510(k) permission to market a complete foot and ankle Trauma and Degenerative product line including compression screws, intermedullary rods and variable angle locking plates.

Director of Product Development Titan Spine, LLC Aug 2008 – Nov 2015

Startup Medical Technology Venture focused on spinal interbody fusion devices.

Managed staff of eight on several large, complex new product projects bringing industry changing and highly effective disruptive technologies into the Spinal interbody market.

Developed 3D printed implantable devices at half the cost of conventional manufacturing methods and are delivered in one third the time with superior bone growth stimulation. This product was not commercialized.

Launched 9 new Interbody devices utilizing Patented technologies and pioneering technologies.

Developed and implemented a strategy for the dramatic expansion of the Company’s IP portfolio from 2 troubled applications to more than 60 awarded assets, gaining key protection in both US and International marketplaces.

Extremities Project Manager and Engineer Wright Medical Technologies June 2003 – May 2007

Managed staff and designs for 14 new products from early concept to product launch.

CHARLOTTE™ Product Line introduction and first year results of $9M

Numerous product line enhancing additions, several multimillion dollar first years at launch in the highly contested Extremities market, some patent applications submitted, LOCON VLS™, EVOLVE Radial Head Plate System.

Consulting Project Engineer OsteoMed Sep 2002 – June 2003

Lead Product Development and Process Enhancement

Key new and innovative, patent protected disposable cranial flap fixation device, first year sales in excess of $2 Mil..

Introduced project management and strategic product pipeline planning techniques and practices.

Director of Engineering/Regulatory Machined Metals, Inc. Aug 2001 – Sep 2002

Primary Manufacturer for a Worldwide Leader in the Design and Distribution of Arthroscopic Implants and Surgical Instrumentation. Responsibilities included Project Manager for Sterilization and Packaging Facility

Managed prototype department consisting of designers and prototype production staff. Staff size varied from 20 – 45 individuals broken into teams.

Developed and implemented in house Vacuum Heat Treating system for stainless steel instrument production system and utilized same to dramatically (<50%) reduce re-work, and rejected products.

Consulting Engineer Feb 1999 – Jul 2001

Worked on regulatory, design, marketing and sales projects for medical, dental and device manufacturing companies in the South Florida area.

Regulatory Consultant - Composed and successfully completed submissions for permission to market dental implants, composed test protocols, engineering reports and managed activities in support of same.

Consulting Engineer - Designed and oversaw manufacturing of dental implants and prosthetics for small startup and provided support at device manufacturer.

Director of Engineering/Development Sterngold Inc. Apr 1991 – Jan 1999

Worldwide Leader in the Manufacture and Distribution of Dental Implants, Attachments, Alloys and Restorative Materials. Initially employed by Impla-Med, Inc. purchased by Sterngold in 1993.

Management Activities (Director of Operations, 1995 – 1998)

Managed Manufacturing Department, 2 Supervisors and 6 Production workers.

Managed Inventory Control Department, 1 Supervisor, 4 Technicians.

Managed Shipping Department, 1 Supervisor, 6 Clerks.

Highlights of product development activities:

Implant and Prosthetic Systems for Dental Implant Product line, additions to offerings in 1998 alone totaling more than $1 million dollars in new sales.

Designed and launched one of the industry’s first advanced and highly effective Self Tapping Dental Implant System this is a Double Lead screw thread, advanced thread forming tip that preserved bone regardless of density.

Designed and fielded the first of the current industry standard surgical instrument kits where the drill’s location is marked with colored lines that can be followed sequentially simplifying surgical treatment.

Manufacturing Processes Implemented

Designed, Sourced and Validated an in house Aseptic (Class 10,000) Modular Clean Room for packaging of sterile implant products.

Reorganized and revised the way a foundational product was by moving the process from machining to casting, further improving the output of the production from a 10% yield to a 90% yield.

Regulatory Accomplishments

ISO 9001 for facilities in Sunrise, FL (Impla-Med) and ISO 9001 for facilities in Attleboro, MA (Sterngold)

Composed 14 FDA 510k Submissions for Permission to Market Medical Devices, received permission to market on all products and systems submitted.

Attended 4 FDA Onsite Audits of Medical Facilities, senior Representative of Management for two of the audits.

EDUCATION

Master of Business Administration – Management

American Intercontinental University, Chicago, IL

2007

Bachelor of Business Administration – Management and Leadership

American Intercontinental University, Chicago IL

2006

Attended classes for Bachelor of Science Mechanical Engineering

University of New Hampshire, Durham and Concord NH

1984 – 1988



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