JOHN E. HAMM

**** ***** ****** *****, **********, FL 33761 727-***-****

http://www.linkedin.com/in/johnehamm acere0@r.postjobfree.com

PROFESSIONAL SUMMARY

Accomplished Project Manager with extensive experience in the medical device industry. Proven history

of managing projects in a challenging highly regulated environment. Experienced with new product

design and development, design control, remediation programs, special projects, quote preparation,

customer relations and training. Successful at leading large Project Teams and Task Forces as well as

small focused groups. Proven success with design and development of complex systems of surgical

instruments and implantable human medical devices. Comprehensive background in research and

commercializing several state of the art medical implants and instruments.

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Project Management Engineering Expertise

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Product Development Customer Relations

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Medical Device Experience Design Control Remediation

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Regulatory Compliance Quote Preparation

PROFESSIONAL EXPERIENCE

J&J, DEPUY SYNTHES, WEST CHESTER, PA 2013 to 2014

Depuy Synthes is the orthopedic division of J&J. It is one of the major orthopedic implant manufacturers

in the world.

Project Manager, Global Remediation Quality Plan Group, Quality PMO Office

Global Program Management for remediation of design controls, verification & validation SOP’s, test

methods, and statistical techniques. Management reports for program status and logistics. Contract

consultant employed through ALKU Technologies.

• Plan, schedule, and expedite SOP updates, Work Instructions, and Policies to address CAPA’s.

• Coordinate updates over four quality / documentation systems used globally.

• Plan, coordinate, and staff remediation of Design History Files to current standards.

JABIL, SAINT PETERSBURG, FL 2011 to 2013

Jabil is one of the world’s leading contract manufacturers of electronics and complex electro-mechanical

devices. Jabil’s Health Care and Life Sciences Group provides design, development, and manufacturing

support for customers. Managed from Saint Petersburg, FL, the HCLS Group works with medical device

design centers located in Saint Petersburg, Austria, Germany, and Shanghai. Jabil’s overall sales for

FY2012 were $17B.

Senior Program Manager, Health Care & Life Sciences

Prepared design and development proposals and quotes for wide variety of medical devices and diagnostic

systems. Customers included world leaders in healthcare to small start-ups. Quotes varied from $25K to

$5M.

Business Development, Quotations, and Proposals

• Coordinated activities of global teams in preparing NRE costs, prototyping requirements, timing and

schedules for new product development quotes.

• Organized and authored proposals and quotes for medical and health care devices.

• Participated in preliminary early engagement meetings and follow-up quote reviews with customers

for fielding questions and clarifying issues.

• Prepared Statement of Work Contracts (SOW) and project kick-off meetings for successful

proposals. Significant interaction with sales, legal, and customer representatives to successfully

initiate contract design and development projects.

Project Management

• Managed selected medical device design and development projects, working with customers and

global teams to kick-off and organize programs. I also led short-term “demonstration-of-expertise”

projects to supplement Jabil’s quote activities.

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JOHN E. HAMM

727-***-**** acere0@r.postjobfree.com

CONMED LINVATEC, LARGO, FL 2000 - 2010

ConMed Linvatec manufactures a variety of medical products ranging from surgical power tools to

human implants for treatment of soft tissue injuries of the knee and shoulder. Sales of $700 M annually.

Senior Project Engineer

Project manager for design and development of new and existing medical devices. Led cross-functional

teams for a variety of projects. Updated existing products in response to market trends, remediation of

regulatory issues, changing technology, and potential performance improvements.

Product Design and Development

Led complete design and manufacture of three product lines totaling $40M in annual revenue.

• MPower™ System of five orthopedic surgery drills and saws. Responsible for life testing

programs, user validation and IEC60601 compliance testing. Wrote protocols, reports,

coordinated troubleshooting of problems, worked with internal testing laboratory and participated

with UL’s representative for witnessed testing in our labs.

• MicroPower™ System was a new set of twelve small pencil–grip drills and saws. Managed

overall project, responsible for verification and validation, and coauthored user manuals.

• Reengineered existing set of six small MicroChoice™ surgical drills and saws. Design

improvements, fabrication methods, and new electronics were integrated into the MicroChoice

products reducing failure rates and warranty costs.

Regulatory Compliance

Led activities to assure compliance with medical device regulatory rules and European environmental

laws.

• Team leader for remediation and to establish compliance with European Union Medical Device

Directives for 260 legacy products. Efforts of seven person team allowed regaining $10M of

sales in key European markets within 30 days and another $6M in the following 90 days.

• Implemented Linvatec’s programs for compliance with European Union regulations regarding

RoHS and WEEE. Activities included educating senior management about the regulations,

formulating plan, getting funding and staffing, changing labeling, modifying product markings, and

implementing the formal reporting through thirty-two European Country Managers. Served as the

expert resource to four other ConMed Divisions regarding these regulations.

• Led subgroup of large remediation team resolving hundreds of regulatory compliance issues.

Team resolved issues relating to engineering verification / validations, deign controls, quality

systems, manufacturing documentation and other audit observations. Successful completion of

these tasks allowed Linvatec to resolve major issues with FDA.

MEDTRONIC, SPINE AND NEUROSURGERY DIVISION, Goleta, CA 1997 - 1999

Medtronic Spine and Neurosurgery provides products for hydrocephalus management, neurosurgery,

and neurocritical care, including neurosurgical instruments, neuroendoscopes, and hydrocephalus

shunts.

Project Engineer

Managed design and development of new medical devices. Led cross-functional team for introduction of

new neuroendoscopy instruments.

• Team Leader for introduction of surgical instruments and accessories for neuroendoscopy into

the Medtronic product line. Neuroendoscopy was a major expansion of the division’s product line

and added significant sales.

• Leader of task force to evaluate internal systems at PS Medical Division, proposing methods to

improve accuracy, efficiency and response time of Product Development, Manufacturing, Quality,

and Specials. Several recommendations were successfully implemented.

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JOHN E. HAMM

727-***-**** acere0@r.postjobfree.com

C.R. BARD, UROLOGY DIVISION, Covington, GA 1994 - 1997

Bard’s Urology Division manufactures a variety of catheters, surgical implants and electronic diagnostic

devices. $176M annual sales for this division of C.R. Bard.

Senior Project Engineer

Coordinated design and development activities, document specifications, and supervised testing

protocols for human implants, various electronic medical devices, and surgical accessories.

• Team Leader for human implant team, designing new instrument system for implants treating

incontinence. Human pilot study for this system was very successful as a result of the new

instrument system.

• Presented the Human Implant Project Overview to Bard’s Corporate Senior Management. This

was a tremendous opportunity, interacting with senior level corporate management.

• Managed R&D Mechanical and Special Projects Laboratories. Direct supervisor of three lab

technicians.

DEPUY INC. (DIVISION OF J&J), Warsaw, IN 1988-1994

DePuy is a major manufacturer of orthopedic joint replacement systems and related surgical equipment.

Senior Product Development Engineer

Multiple responsibilities included design of implants and instruments, managing specialized customer

services, coordinating development activities, documenting specifications, verification of new designs,

validating performance of new systems, training of surgeons and sales professionals, and representing

DePuy at various forums.

• Implemented and managed Depuy’s Surgeon Service Program for Knee Systems. Developed

custom surgical instruments to aid in converting key surgeons to DePuy joint replacements.

Worked with surgeons and their sales associates to evaluate their custom instrumentation

needs. Very successful program, resulting in 63% sales increase annually from targeted

accounts.

• Team developed new user-friendly knee surgery instrument set that enhanced appeal of

DePuy's knee prostheses to surgeons. Knee system’s sales increased 66% from prior year.

• Member of DePuy-DuPont Joint Venture Team, developing and commercializing new materials

and designs for orthopedic sports-medicine implants. This included developing surgical

techniques, instrumentation, appropriate animal models, and training materials.

• Part of three person Marketing / R&D team developing of new products to aid in reconstruction

of the cruciate ligament of knee. Introduced five significant new products within three years,

successfully establishing a DePuy presence in a new, growing market segment.

ZIMMER ORTHOPEDICS, Warsaw, IN 1974-1988

Zimmer is a major manufacturer of orthopedic implants and related surgical equipment. Zimmer was one

of the top two orthopedic suppliers in my product lines during my tenure with the company.

Senior Product Development Manager

Coordinated design and development activities for total hip replacement systems. Significant interaction

with surgeons, research professionals, and sales team. Responsibilities included documenting

specifications, evaluating materials, coordinating lab testing, preparing protocols for FDA Class 3 human

implant trials, and much more.

• Managed project teams of various sizes and scope.

• Designed a wide variety of orthopedic implants and surgical instrumentation. Cradle-to-grave

responsibility for product lines.

• Managed long term projects which spanned initial development, design, debugging, clinical trials,

FDA clearance for Class III implants, manufacturing start-up, market introduction, and promotion.

EDUCATION: Bachelor of Science, Mechanical Engineering, Purdue University, West Lafayette, IN

AFFILIATIONS: Active member of American Society of Mechanical Engineers

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