Engineer Manager

Mark B. Lester

**** *. ******** ****** ******, Indiana 46580

Residence: 574/268-1533

Cell:

***/***-****

Professional Objectives

A challenging and responsible Plant Manager / Business Unit Management

position with a progressive company which can benefit from experience with

new business unit start-ups and management along with my professional

abilities in engineering, product development, operations, strategic

planning, problem solving, recruiting top talent, marketing, customer

focus, communication, and commitment to excellence to produce innovative

products and services required for the Market.

Professional Background

Biomet Trauma, LLC

Warsaw, In

Director Product

Development Septembe

r 2010 - P resent

Responsible for the Global management of the Trauma product development

organization including strategic planning. acquisitions, forecasting,

budgeting, talent management, development of innovate product, product

maintenance, marketing, sales training, and development and strengthening

of surgeon relationships working with the sales force.

Experience working with in 3D modeling and Data Management systems,

Regulatory, Testing, Quality, Operations, Legal, Purchasing, Planning,

Customer Service, Packaging and Labeling Departments to assure compliance

with company, GMP, and FDA guidelines and Regulations.

Successfully turned Trauma organization sales from a double digit loss to

double digit growth in two years.

Depuy a Johnson & Johnson Company

Warsaw, In

Director Product Development -

TruMatch Jan 2008 - Sept

2010

Lead new technology and systems development for JIT application of patient

matched instrumentation for Hip and Knee procedures utilizing MRI and CT

technology and 3d modeling systems integration. Successfully worked with

internal and external resources to investigate, develop, and implement new

software and systems for imaging, processing, production, inspection, and

shipping of patient anatomy matched instrumentation using automation tools

to meet high volume demands. Successfully developed new technology in 18

months and grew department sales to $4M dollars in sales in 2.5 years.

R&D Director - Development Engineering Services July 2006

- Jan 2008

Responsible for the Global management of Design Engineering, Rapid

Prototype, Prototype, Custom Products, Technical Engineering Systems,

Industrial Design, and Business Information Services supporting development

engineering for hips, knees, trauma, extremities, custom implants and made

to order instrumentation.

Successfully created and implemented World Wide initiatives for global

design standardization, engineering standards, and development of

performance evaluation metrics in support of design anywhere build anywhere

initiatives in 18 months.

R&D Group Manager, EITS January

2005-July 2006

Responsible for the management of Design Engineering, Rapid Prototype,

Prototype, and Business Information Services supporting development

engineering for hips, knees, trauma and extremities.

Successfully applied new rapid prototype and manufacturing technology, EOS

and ARCAM, to the orthopedic industry resulting in reducing product

development time by 40% and prototype costs by 30%.

R&D Manager, Knees January

2004-January 2005

Responsible for the product development, management, and marketing of Limb

Salvage and revision knee product. Successfully developed innovative

modular salvage system in less than 20 months and became #2 system on the

market in less than 2 years.

R&D Manager, C.O.R.E.

Extremities July 2002-December

2003

Responsible for the development, management, and marketing of oncology and

end stage revision product.

Successfully developed new product technology and incorporated sister

company technologies into viable features and enhancements within new joint

implant systems.

Group Product Development Manager -

Orthogenesis Jan 1999 - July 2002

Responsible for creating state of the art Customs and Specialty Product

department including the consolidation of DePuy and Johnson & Johnson

technology.

Successfully developed streamlined procedures and protocols that comply

with FDA, GMP, ISO, and Quality requirements. Built department from ground-

up and to $1M dollars in monthly sales in less than two years.

Sulzer Orthopedics Inc.

Austin, Tx

Supervisor / Product Engineer / Product Manager - Select Market

Products Aug 1997 - Dec 1998

Responsible for developing, marketing, and managing Select Market Product .

Develop 510(k) or 510(k)able devices to support low volume and/or niche

product. Develop product from concept through production and successful

transfer into standard product inventory. Comply with all FDA, GMP, ISO,

and Quality requirements. Successfully investigated new long-term product

ideas while advancing current technology through state of the art imaging

and rapid product modeling and development systems.

Senior Product Development Engineer - Custom

Product Dec 1992 - Aug 1997

Responsible for developing, marketing, and managing custom products.

Created department procedures and protocols, marketing literature, testing

protocols, and support data for 510(k) submissions. Comply with all FDA,

GMP, ISO, and Quality requirements. Successfully built business unit from

scratch including, staffing, machine selection and procurement, procedure

and processing development, and implementation to become a top three player

in the orthopedic market in less than three years.

Zimmer, Inc.

Warsaw, In

Senior Development Engineer - Custom

Product Oct 1992 - Dec 1992

Successfully managed custom department personnel to develop custom devices

based on surgeon specifications and patient requirements inside an average

two week lead time. Reduced leadtime from six seeks to two weeks on

average. Worked with upper management, their subordinates, and other

support departments such as marketing, international, regulatory affairs,

legal, finance, planning, manufacturing, quality, purchasing, and outside

vendor resources to provide effective and efficient product in a timely

manner.

Development Engineer - Custom

Product Nov 1991 - Oct

1992

Utilized two and three dimensional computer aided design systems to model

custom implants based on surgeon specifications and patient requirements to

develop and produce Custom devices. Worked with upper management, their

subordinates, and other support departments such as marketing,

international, regulatory affairs, legal, finance, planning, manufacturing,

quality, purchasing, and outside vendor resources to provide effective and

efficient product in a timely manner.

Development Engineer - Hip

Development Jan 1991 -

Nov 1991

Successfully developed new innovative hip product along with supervision of

assigned support drafting and project engineering personnel. Responsible

for the design, development, and management of new and existing standard

line Hip product.

Project Engineer - Hip

Development Jan

1989 - Jan 1991

Responsible for design, development and management of existing standard

line hip product as assigned by the Development engineer.

Successfully incorporated and debugged new solid modeling software system,

Pro-Engineer to be incorporated as a design tool for design engineers for

conceptual purpose to reduce development lead time and redesign time along

with useable electronic data for downline programming.

Product

Designer

Nov 1987 - Jan 1989

Supporting design-engineering group by creating three-dimensional models

utilizing Cadds-aided software to conceptualize the design of new products

in order to evaluate and analyze quality, tooling, functionality, and

manufacturability. Complete tolerance studies of mating parts and

generation of production drawings as well as drawing maintenance for

existing product. All design work done utilizing Computervision CDS 4201

Rev 5.

Square D Company

Peru, In

Product

Designer

Feb 1982 - Nov 1987

Responsible for design and development of switchboards and their

components; testing, evaluating new design to U.L., N.E.C., and company

standards; trouble shooting manufacturing, and field problems,

incorporating cost reduction programs and field investigations. Supervised

drafting personnel. All design work done utilizing Computer vision CDS 4201

Rev 4&5.

Shirt Shed, Inc.

Wabash, In

Supervisor Darkroom Operations - Graphic

Arts Oct 1980 - Nov 1981

Responsible for all film and negative development, chemical mixing, supply

ordering, maintenance of equipment, all studio and reproductive

photography, generation of special effects photography, and supervision of

a department four technicians.

Patents

* Centraline Hip Prosthesis 5,116,380

* PMMA Spacer 5,163,963

* Acetabular Cup Prosthesis Positioning Instrument DES 331,461

* Surgical Reamer Assembly 5,169,401

* Instrument for Evaluating Balance of Knee Joint 6,022,377

* Implantable Orthopedic Prosthesis Having Tissue 6,127,596

Attachment Surface and Method for Manufacture

* Distal Femoral Osteotomy System and Method 6,183,475

* Press Fit Acetabular Cup 6,626,947

* Modular Long Bone Prosthesis for partial or 7,435,263

Total Bone Replacement

* Soft Tissue Attachment System and Method 7,476,255

* Adjustable Orthopaedic Prosthesis and assoc Method 7,481,841

* Modular Implant System with Fully Porous Coated sleeves 7,799,085

* Customized Patient-Specific Instrumentation for use in 8,377,068

Orthopaedic Surgical Procedures

*Femoral Tibial Customized Patient-Specific Orthopaedic 8,398,645

Surgical Instrumentation

*Customized Patient-Specific Bone Cutting 8,419,740

Instrumentation

*Customized Patient-Specific Instrumentation for use 8,425,523

In Orthopaedic Sugical procedures

* Patellar Prosthetic arrangement and assoc surgical method 2003/0120346

A1Patent Pending

* Modular Limb Preservation System 2003/0204267 A1Patent

Pending

* Patellar Implant system 2005/0143830 A1 Patent

Pending

* Modular Orthopaedic Implant System 2006/0041317 A1 Patent

Pending

*Customized Patient-Specific Bone Cutting Bock 2009/0088763 A1

Patent Pending

With External Reference

* Customized Patient-Specific Patella Resectioning 2010/0185202 A1

Patent Pending

Guide

Education

Indiana University, IPFW Fort Wayne, Indiana

Major: Mechanical Engineering Technology

Minor: Supervision and Management

Degree: BGS, Dec 1991

Purdue University, IUK Kokomo, Indiana

Major: Mechanical Engineering Technology

Degree: AAS, May 1987

Indiana University, IUK Kokomo, Indiana

Major: Industrial Design

Degree: AGS, May 1985

Other Education

Bloodborne Pathogenes and Human Source Materials - Johnson & Johnson

2008

Health Care Compliance - Johnson & Johnson

2007

HIPPA Privacy - Johnson & Johnson 2006

Leadership in a Global Organization - Johnson & Johnson

2006

Management and the Law / DePuy - Johnson & Johnson

2002

Management Fundamentals / DePuy - Johnson & Johnson

2002

Effective Project Management / DePuy - Tech-Con, Inc

2001

Bone and Soft Tissue Tumors: A Multiplicinary Approach / DePuy - Mayo CME

2000

Standards of Leadership / DePuy - Johnson & Johnson

2000

Operating Room Protocol for Medical Industry Professionals / DePuy -

Education Design 1999

Finance and Accounting for Non-Financial Managers / DePuy - Fred Prior

Seminars 1999

Concurrent Engineering / Sulzer

1998

Marketing Fundamentals / Sulzer - AMA (American Management Association)

1997

Manager as Coach Workshop / Sulzer

1997

Engineer as Manager and Leader / Sulzer - Texas Tech University

1996

Negotiation and mediation / Sulzer - Chorda Conflict Management

1996

Advanced Mediation / Sulzer - Chorda Conflict Management

1996

Leadership / Sulzer - AMA 1996

Marketing / Sulzer - AMA 1996

Finance / Sulzer - AMA 1996

The Art of Management / Sulzer - AMA

1995

Fundamentals of Risk Management / Sulzer

1994

Advanced Pro-Engineer Training / Sulzer - Parametric Technologies

1993

Pro-Engineer Basic Training / Sulzer - Parametric Technologies

1993

Advanced Biomechanics / Zimmer

1992

Basic Biomechanics / Zimmer 1992

Human Anatomy / Zimmer 1992

Quality Management / Zimmer - ISO 9001 Quality systems

1991

Design for Producibility / Zimmer - Society of Manufacturing Engineers

1990

Pro-Engineer Solid Modeling Software / Zimmer - Parametric Technologies

1989

Concurrent Engineering / Zimmer - Purdue University

1989

Time Management / Zimmer 1989

Quality Education systems Training / Zimmer

1989

Open Plan Software Seminar / Zimmer - Batell

1989

Engineering / Project Management / Zimmer - Batell

1989

Geometric Dimensioning and tolerancing / Zimmer

1988

Advanced Surface Design / Zimmer - Computervision

1988

Advanced Mechanical Design / Zimmer - Computervision

1988

Professional Organizations

SME, Society of Manufacturing Engineers, Senior Member

ASME, American Society of Mechanical Engineers, Associate Member

BME, Biomedical Engineering Society, Member

References

Available upon request

Contact this candidate