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Project Manager Medical Device

Location:
Chandler, AZ, 85226
Posted:
May 04, 2011

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Resume:

Summary

Lean Manufacturing Professional with expertise in multisite

operations, P&L/general management, track record of global success

implementing lean manufacturing in diverse manufacturing and

transactional environments.

. Led operational turnaround resulting in world-class showcase

manufacturing and distribution organization.

. Slashed manufacturing costs 28% through yield improvements,

labor savings, and productivity initiatives.

. Drove $30+ million revenue increase and reduced defective

materials by 50% by implementing standard work.

. Resolved systemic process failures, as identified by a

Federal agency (FDA), lifting the constraints of a warning

letter.

TENACIOUS ACHIEVER...improves profitability by targeting

inefficiencies, minimizing expenses, and increasing revenue.

. Improved EBITDA to 14.3% and increased sales $2.5 million

annually by building solid relationships with customers.

. Reduced operating expenses by $14.0M annually through facility

consolidation.

. Delivered additional $1.1M in annual profit for an auto parts

supplier through the application of TPS principles.

. Enhanced cash flow $14 million by reducing inventory level 43%

and establishing materials management system.

. Eliminated OSHA recordable incidents through safety awareness

programs.

ADEPT STRATEGIST...exceptional ability to resolve complex business

challenges and attain peak levels of performance.

. Reduced product variation 40% through 1st-time implementation

of statistical quality controls and documentation.

. Decreased packaging costs $600K annually by reengineering

equipment and installing poka yoke.

. Achieved ISO 13485 registration on initial audit; upgraded to

ISO 13485-2003 within 9 months.

. Led a global lean transformation from design through

implementation for a major Aero company.

. Designed and implemented Toyota-based business systems for 3

major U. S. manufacturers.

CHANGE CATALYST...well-rounded management style creates common vision

and forges positive relationships.

. A capable, articulate communicator who leads by example and can

"walk the talk"

. Recognized by employees for leadership: "Your guidance and

caring helped us become the #1 team with pride."

. Acts as a mentor to team members; transferring knowledge to

help them develop personally and professionally.

. Quick to learn local customs and culture in order to gain

credibility and support in foreign environments

. Created successful employee development plan leading to

multiple promotions.

Professional History

Made-Rite Systems - Chandler, AZ - August 2010 -

Operations Coach and Lean Advisor

Conduct operational Lean assessments and distill findings into an

actionable plan for company leadership. Act as a trusted advisor to

the executive level primarily regarding lean manufacturing

application, facility expansion/consolidation, sourcing/supplier

issues, and organizational performance. Fulfill specific roles (i.e

plant manager, project manager, etc.) as recruiting efforts are in

process. Coach managers, supervisors and their direct reports in

adapting to the requirements of a Lean Thinking organization.

. Implemented Lean principles at an instrumentation manufacturing

company including but not limited to: standard work, 5 S,

visual management, pull system, lean materials process. This 5

week effort immediately yielded an order to shipment lead time

reduction of 93%, a 50% improvement in fill rates and cycle

time reductions averaging 29%.

. Reengineered a supply chain from a traditional forecast driven

planning system to a demand driven replenishment system which

resulted in a raw material reduction of 29%.

. Led a one week SMED Kaizen event resulting in an additional

annual profit of $1.083M for the client.

. Play a pivotal role as "sensei" for clients' staff in an effort

to develop the necessary skills and behavior to support a Lean

Enterprise.

Tefen Management Consulting - New York, NY - May 2005 - May 2010

Director (July 2006 - May 2010)

Assumed full responsibility in managing the medical device practice,

providing thought leadership to engagement teams, fulfilling "trusted

advisor" relationships with executives and senior managers, expanding

service offerings to new and existing clients and ensure adequate

resources were assigned and capable of delivering maximum value as

defined in the project scope. Collaborated with the sector partner to

review trends in the medical device industry and formulate relevant

solutions. Proactively participated in various business development

activities. Contributed as a core member of the company's Leadership

Team.

. Solely reengineered a complaint management process in an FDA

regulated environment, which resulted in a 68% reduction in

backlog of complaints, more thorough investigations, and a

reduction in lead time to process a complaint of 39%.

. Developed facility rationalization plan for a scientific

instrument manufacturer, which included footprint

consolidation, outsourcing and manufacturing process

improvements resulting in an annual savings of $14M.

. Single-handedly improved manufacturing efficiencies for an

electronic sensor manufacturer in fabrication (surface mount

and wire bond) and assembly, resulting in an overall

productivity gain of 28% that ultimately reduced product cost

by $1.1M annually.

. Designed and implemented a comprehensive supply chain risk

assessment process for a global medical device manufacturer.

This effort was paramount in closing a warning letter the

company had received from the FDA.

. Presented essential concepts at several conferences; which were

immediately published in Purchasing B2B and Medical Product

Outsourcing.

. Developed and led 3 distinct multi-site improvement initiatives

requiring significant planning, communication,

implementation/follow-up support and multi-tiered client

interaction.

. Successfully led delivery teams in Ireland and Costa Rica

. Was instrumental in conducting Kaizen events for various

clients. Easily adapted to changing environments/industries to

facilitate change and drive operational performance for

clients.

. Participated as a key member of Tefen's leadership team and

subsequently contributed to numerous management decisions.

Project Manager (May 2005 - July 2006)

Accountable for quantifying/achieving benefits to be realized through

implementation efforts, as well as supervising multiple client teams

throughout the project. Mentored new consultants on analysis and

improvement techniques. Facilitated long range planning sessions. Key

contributor to internal Knowledge Management System.

. Exploited my diverse background to develop robust solutions to

complex business issues which our clients were experiencing.

. Dedicated to 5 month project in Guadalajara, Mexico and 6

months in Tijuana.

. Enhanced all opportunities to offer additional consulting

services.

. Proactively contributed to content improvement for a broad

array of service offerings.

. Imparted expert oversight and thought leadership to benefit my

delivery teams and ensure client satisfaction throughout

engagements.

. Planned and conducted Comprehensive periodic high level reviews

to ensure delivery quality and financial results were met.

Doctors' Research Group, Inc. - Plymouth, CT - July 2003 - May 2005

General Manager

Full P&L accountability for the unit and responsible for various

business functions including quality, business development,

manufacturing, IT, finance, and materials within a class II & III

medical device manufacturing environment.

. Co-Developed and manufactured a custom cranial implant for a

strategic business partner

. Successfully closed contracts with key customers, which

increased sales by $5.0M.

. Instrumental in leading the business to profitability for the

first time (achieved an EBIT of 11.2% initially).

. Implemented SMED and single piece flow manufacturing cells and

CNC machining operations.

. Successfully achieved and sustained order fill rates of 98%

. Recruited competent talent to fill key functions (Quality

Director and Materials Manager).

. Successfully championed and achieved ISO 13485 certification

within 8 months.

. Demonstrated expertise in increasing productivity by 45% while

maintaining a "zero incident" track record for safety.

The Competitive Edge, LLC - Plymouth, CT - July 2000 - July 2003

Principal

Acted as the executive level advisor regarding lean manufacturing

application, facility expansion/consolidation, product

rationalization, sourcing issues, and performance metrics. Fulfilled

specific roles (i.e plant manager) when necessary and successfully

coached various senior managers to adapt to the requirements of a

Lean Operating system.

. Developed and led multi-site Lean transformations for a

commercial boiler manufacturer, a pool products company and a

commercial floor care equipment manufacturer. Through the

application of the Toyota Production System, these companies

reduced inventories by several million dollars, benefitted from

productivity increases ranging from 27% to 46%, Experienced

improved order fill rates during seasonal high demand periods

of 68% and each consolidated at least one manufacturing

facility.

. Led a transformational turnaround for a metal fabrication

operation where the following was achieved in a 2 year period:

OTD from 28% to 98%; scrap reduced by 75%; WIP inventory

reduced by 70%; productivity increases of 32%

. Significant improvements made possible through my natural

ability to assume a leadership position and to influence and

persuade people to participate in change efforts.

. Fulfilled interim management assignments in parallel to the

revamp of client's production systems.

. Planned and improved course of action for new clients with

deliverables that aligned with the financial and operational

objectives defined in strategic plans.

. Played a pivotal role as "sensei" for clients' internal change

agents.

. Completed the facilitation of hundreds of kaizen events.

Innovative Manufacturing Technologies, Inc. - South Windsor, CT -

Jan. 1996 - June 2000

Manager

Constantly managed teams to achieve higher performance and repeat

business within various industries, including aerospace, medical

device, automotive and consumer products. Executed international

assignments in United Kingdom and Canada. Collaborated with senior

managers to improve and streamline organizational alignment.

. Managed client groups toward development and implementation of

various strategies for continuing process improvement.

. Designed and developed an effective road map for clients to

improve operational and financial performance through the

application of process improvement and waste elimination

strategic plans.

. Influential in establishing new metrics for the lean

enterprise.

. Demonstrated expertise in operational excellence in directing

efforts throughout the completion of a "Big 5" international

engagement project.

. Assigned to Derby, England for a six month project

. Relocated to Montreal, Canada for 18 months to support

transformation efforts

Earlier Career

U. S. Surgical Corp. - North Haven, CT - Dec. 1989 - Dec. 1995

. Manager, Office of Continuous Improvement

. Responsible for Lean implementations in 2 US facilities and 1

in Puerto Rico

. Manufacturing Manager (700+ employees)

. Superintendent R&D/Advanced Manufacturing

. Manufacturing Supervisor

EDAL Industries, Inc. - East Haven, CT - Aug. 1986 - Dec. 1989

. Manufacturing Supervisor

Military Service

Connecticut Air National Guard

. Air Control and Combat Radar Mechanic 1982 - 1988

. TDY - RAF Lakenheath U.K.

Education

Shaftesbury University - London, England

. Masters of Business Administration May 1996

. Bachelor of Science - Operations Management May 1986

Community College of the Air Force

. Associate Science in Electronic Technology Dec. 1982

Professional Development

. NCO Leadership Training ? USAF Community College

. Studied the Toyota Production System under sensei Chihiro Nakao

of Shingijutsu Co., Ltd. in Gifu City, Japan

. 4 consecutive weeks in Japan, an additional 6 weeks in the US

. Several more months under the guidance of an American trained

by Mr. Nakao

. Certified Six Sigma Black Belt[pic]



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