Seeking managerial position in Manufacturing, Product Development or Program Management within the medical device industry. I have extensive experience that includes management-level positions in product development and manufacturing environments. My background includes leading teams and managing 8 plants for process, tooling and engineering and managing a budget of $3 million and holding full P&L responsibility. I have been recognized frequently by upper management for my contributions to groundbreaking product development and launch. I excel in establishing a focus for work forces, providing motivational support, and inspiring top performance from team members as a leader and mentor. I offer a diversified business acumen and expertise in engineering disciplines, with an analytical, strategic, and global mindset that I apply to all initiatives and goals. I am now seeking the opportunity to leverage my experience, expertise, and broad skill sets in a challenging leadership role.
Skill Highlights
Project Management
Design for Manufacturing
Plastics Engineering
Automation and Assembly
Material Sciences
Total Quality Management
Strong Analytical Skills
Manufacturing Management
Risk Management
Team Player
Visionary
Vendor Sourcing
Strategic Planning
Lean Manufacturing
Core Accomplishments
Project Management: Have successfully managed the design and launch of ten medical devices
Operations Management: VP of Technology and Engineering for a 350 Million Dollar Injection Molding and Medical Device Contractor
Managed Tooling and Engineering Departments
International Experience in Manufacturing
Patents in Material and Medical Devices
Professional Experience
Managing Partner, 05/2013 to 2016 Darden Restaurants, Inc. – Marysville, WA,
Returned to the Raincross Group after 20 months for Covidien EV-3.
Focus is the development of a new processing aid for plastics injection molding.
Reviewed the design of an injection molding autoinjector housing for a Bio-Tech Company and a new cardo-catheter.
Redesigned a biopsy grasper to reduce manufacturing cost for Boston Scientific.
Manager of Mechanical Engineering, 08/2011 to 05/2013 Seasons 52 – Palm Beach Gardens, FL,
Originally, I was brought into Covidien EV-3 as a consultant to correct issues with Covidien's Marksman Catheter.
The Marksman catheter was designed to resheath a stent.
The original Marksman design would not, and the catheter had been launched.
After reviewing the design and manufacturing process, a new design and manufacturing process was implemented and within eight weeks the problem was solved.
This project started in September 2011.
By March 2012, I was hired by EV-3 to form the new PD team for the Access Franchise that included all new catheter design and manufacturing.
Eight engineers and technicans where either hired or added to the team.
The team was successful in designing equipment and processes while launching the new Navien Guide Catheter for Neurosurgery.
Sucessfully automated part of the production process and reduced labor and cost significantly, eliminating 10 operators and reducing one manufacturing step from 45 minutes with 40% yield to a 5 minutes process with 90% efficiency.
Operation finished the implementation.
Successfully conceived and developed a new filament winding process for producing Nitinol coiled catheters.
Team released five new Navien Guide Catheters in less than fourteen weeks from design to full release.
Managing Partner, 2008 to 11/2011 National Financial Partners Corp. – Sherman Oaks, CA,
Development of neurosurgerical catheters and stents for Covidien Redesigned a new introducer which required the development of a new manufacturing process to complete the product.
Launch was completed on time.
Second generation in design.
Launched a new anchor screw for rotator cup repair for Fortune 500 orthopedic company.
Contracted by Johnson & Johnson Centacor Division to return as Core Competency in plastics design & manufacturing.
This successful product launch took place in 2009, and was a new auto injector developed and produced in Oxford England and the J&J Swiss operation.
High production tooling followed in 2010.
Development of advanced catheter technology in accordance with lean manufacturing and the advancement of coiling technology.
Designed and conducted the material selection process for the FDA 510 process on a safety syringe and an IV Port.
Reviewed large medical sub-contractors' production lunches for Baxa and Acists in Tijuana facility.
Served as acting Director of Engineering to Nypro Healthcare Baja to reorganize and establish engineering support for their assembly and molding operation.
Established new tooling center and hired all staff including engineering team.
Assisted in the design and modification of design for DFM on a safety syringe and a safety IV injection port.
The safety syringe program has been launched in Europe and in production.
Vice President, 04/2007 to 2008 Seasons 52 – Paramus, NJ,
Joined Solace Therapeutics Inc,.
A start-up in the middle of a PMA study, to develop a balloon product for female inconstancy.
Identified adverse issues and made several design changes.
Second and third generation products were designed and successfully launched in Europe in 2010.
Solace failed its initial PMA study and the California R&D center was closed and moved back to Boston.
Managing Partner, 01/2003 to 03/2007 Gerber Scientific Inc. – Atlanta, GA,
Tooling and start-up of a Chinese/US assembly for a cardiovascular arterial device for a major medical device company.
Total project cost was several hundred of thousand dollars.
Designed a new coil, braided wire, and composite catheter, as well as the development of the manufacturing processes.
Expertise in micro-catheter and micro medical devices design and manufacturing.
Established business relationships with several US medical device contractors and Chinese suppliers, resulting in $3 million dollars in annual sales.
VP of Engineering and Technology, 02/2000 to 2003 Activision – Irvine, CA,
Part of senior leadership team for $350 million medical device subcontracting start-up funded by Aurora Capital.
Responsible for all engineering and conversion of three medical assembly plants.
Established an Engineering Center of Excellence in Chicopee, MA.
Reports included seven directors and a staff of 120 associates in three departments from 8 plants.
Core focus of role included market development and sales of medical device manufacturing capabilities.
Key executive and lead technical advisor in the establishment of UPG's Medical Division.
Principle Engineer, 1995 to 02/2000 Department Of The Interior – Casper, WY,
Initially hired as Core Competency for Plastics Engineering & Design Group within R&D.
The purpose was to determine the root cause of the failure of surgical instrument EZ-35, which resulted in death to a patient and to develop a corrective action plan to prevent future failures.
The failure mode was quickly determined to be a glass filled nylon gear that was not produced correctly.
Assigned as Team Leader to put a system in place to assure that bad plastics components could not be produced.
The result of five years of procedural technology reviews established a worldwide standard for launching surgical/medical plastic parts.
This standard was adopted by all of J&J's medical device divisions in January 2009.
The introduction of this system reduced cost of plastics components within EES by 10 to 15% as the Division grew from $350 million to $1.4 billion in sales.
Within a 2 ½ month period, designed from concept to launch a new Trocar Sleeve.
This could not be produced with any known technology at that time.
Over a period of 6 weeks, a part was produced along with a major breakthrough in injection molding technology.
This breakthrough still stands today as a technological accomplishment and a foundation for advanced molding of thin wall components, such as cell phone housing.
Personally involved with the design review of all new products in R&D including: DFM, Design for Manufacturability Function design versus manufacturing requirements Material technology in metals, plastics and ceramics Worked with supplier management in reducing lead times, cost of goods, and the transfer of technology to our Juarez, Mexico Plant or sub-contractors Helped supplier management and operation in designing and setting up a vertically integrated injection molding plant in El Paso Texas.
Technical Director, 01/1990 to 01/1995 PE Handley Walker Inc – City, STATE,
Technical director for this international consulting firm specializing in lean manufacturing practices and applications, as well as ISO certification within the US medical device industry.
Analyzed designs for manufacturability as a result of implementing lean manufacturing procedures.
Worked with customers who were involved with product recall (483) or complaints that needed to be addressed with the FDA.
Customers included Baxter Corporation, Pfizer, Mallinckrodt, Bard, and others.
Responsible for technology for the corporate headquarters in London with sales of $300 million.
President, 1981 to 1990 Bastec – City, STATE,
President of private consulting firm responsible for process development of plastic components, carbon-carbon composites, metal matrix composites, and new advanced materials.
Clients included Boeing, Northrop, Mallinckrodt, Cobra Golf, GE Turbine Engine Division, Semins Medical, GE Medical, Sports Medical and Composite Halo Technology, Hexcel, K-2 Ski, Olin Ski Co, Rossignoal Ski Co., Avco Corporation, Baxter Corp.
Bentley Division.
Education
Bachelor of Science: Plastics Engineering, Expected in 1969 University of Massachusetts,Lowell - Lowell, CA GPA:
1999 Presidential Team Award for Quality & Cost Saving Improvements 1999
Nominated for Fellowship @ J&J
PUBLICATIONS Over 70 published articles forwarded upon request
PATENTS Three - Polymer Alloys andTrocar Seal used by J&J
SECURITY CLEARANCE Top secret government clearance - have worked on Stealth Technology
FORMAL INVITATIONS Invited by the University of Moscow to lecture on Silicon Carbide reinforced Titanium
Skills
Professional Consultant, Project Management, Product Design, Engineering Support, ISO, Leadership, Team Leader, Lean Manufacturing, MA, Director Level Experience, Manufacturing process, Market Development and Sales, Materials, Material Selection, Process Development, Safety, Scientific Molding, Supplier Management,
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