Manager Customer Service

Profile:

A results driven professional with extensive, technical, customer and

business experience in capital and disposable medical devices and high

volume and low volume assembly and fabrication. Adept at ensuring

deliverables are produced on time and within budget. Successful, dedicated

leader and motivator accomplished at team building and facilitating

multiple decision makers to reach consensus. Skilled in all phases of

program / project management life cycle from inception through

implementation.

Areas of Strength:

Plant Management CNC Programming and Machining

Operations Management PLC Programming

Engineering Management Cost Reduction

Project Management Data Driven Management

Customer Relations / Service FDA / ISO 13485 Compliance

Budget Development Documentation Management

Contract Development Lean Manufacturing

New Product Introduction Training

Process Development / Improvement IQ, OQ, PQ Protocol Development

Experience:

Engineering - Contract Monroeville, Ohio April 2014 -

Present

Self-employed contract engineer focusing on program management.

Project Manager - Regulatory

. Developed a regulatory plan per ISO 13485 for a start-up

medical device company

. Setup initial project plan to develop the documentation and

processes for ISO13485 certification

Project Manager - Contract

. Responsible for managing the repair and upgrade of an 3300

ton injection molding

. Designed and built a test stand to test PLC controls for

injection molding machines

. Developed the project plan to upgrade a 500 ton Cincinnati

injection molding machine controller.

MC3 Corporation Ann Arbor, MI May 2011 - February 2014

A contract developer and manufacturer of advanced medical devices with

primary focus on advanced Cardio-Pulmonary surgical devices.

Operations / Manufacturing Engineering Manager

. Responsible for developing the strategy for implementation of

manufacturing at the Ann Arbor Facility

. Responsible for the overall budget and operations of the

manufacturing facility.

. Opened a 10,000 sqft. manufacturing facility including

installation of data and communication lines

. Responsible for developing proposal and execution of all

contract design and manufacturing projects.

. Manage a team of two engineers and two direct assembly

personnel.

. Part of three man team responsible for development and

implementation of a quality system for ISO 13485;

certification audit completed 5/2013

. Transferred a heart /lung patient simulator from Australia to

manufacturing resulting in $540,000 in annual sales

. Developed and transferred to manufacturing a UV Sanitizing

device resulting in $380,000 in sales year one with

anticipated sales of $800,000 in year two.

. Responsible for all new product design and manufacturing

. Responsible for all customer contact for active and potential

products

. Developed a service system to support customer product

Sparton Medical Systems Strongsville, Ohio September 2006 -

May 2011

A contract manufacturer of diagnostic and therapeutic electro-mechanical

medical devices.

Operations / Engineering Manager

. Managed a Team of eight Engineers and Documentation Control

Coordinator

. Responsible for the introduction of all new products to

manufacturing

. Point person for all customer related issues during product

introduction

. Responsible for departmental budget development and control

. Responsible for floor support / trouble shooting

. Responsible for cost reduction / process improvement

. Senior team member of the problem investigation and resolution

team (PIRT)

. Facilitated the closing of a sister facility and transferred

seven product lines to the Strongsville Facility through IQ, OQ,

PQ and process validation.

Customer Business Manager

. Program Lead for all new product introduction

. Responsible for development of project time line

. Responsible for contract development and adherence

. Responsible for quality plan and transition plan development.

. Responsible for product and capital budget.

. Redesigned customer service process to improve the repair cycle

and CAR closure timing.

Biomec, Inc Cleveland, Ohio June 2005 - August 2006

A research and development organization for advanced technology medical

devices.

Director of Operations:

. Responsible for the analysis of developing a manufacturing

platform to enhance the value of developed product.

. Developed the cost model for the manufacturing platform

. Developed the floor layout for the manufacturing facility.

. Responsible for the introduction of capital and disposable

medical devices

. Validated the packaging and sterilization of a disposable device

. Developed and documented the five phase new product development

process.

ACMI, Corp Norwalk, Ohio April 1985 - May 2005

A manufacturer of least invasive medical instrumentation for the use in

prostrate, kidney stone, laparoscopy, gastrointestinal and gynecology

procedures.

Plant Manager 2004 - 2005

. Dual responsibility role along with Engineering Manager

. Responsible for the Key Performance Indicators (KPI's) of the

facility with revenues of approximately $45mm annually

. Managed the facility totaling 160 individuals from various

departments including materials, operations, engineering and

customer service with dotted line responsibility for quality and

human resources.

. Responsible for union contract adherence, and facilitator for

third step grievances.

Manufacturing Manager 2001 - 2004

. Dual responsibility role along with Engineering Manager

. Responsible for approximately 120 direct employees along with 8

supervisors over a three shift operation

. Responsible for Key Performance Indicators involving

manufacturing, including delivery, productivity, scrap, rework,

and indirect labor expense

. Responsible for customer repair and service of returned devices.

. Reduced back order level from an average of $150K to under $40K

Engineering Manager 1996 - 2005

. Managed a group of engineers, documentation control coordinator,

tool designers and toolmakers in the support of assembly and

machining activities over three shifts

. Responsible for developing and adherence to expense and capital

budgets

. Responsible for new product introduction of capital and

disposable devices from alpha build to production release.

. Responsible for process development and documentation

. Responsible for change control of design and process

documentation

. Responsible for IQ, OQ and PQ protocol development and execution

and final report

. Responsible for all programming of all CNC and PLC equipment

. Responsible for capital acquisition including selection, request

for capital investment (RCI), installation, training and

validation

. Facilitator for second step grievances

. Team leader in a technology transfer of a rigid optical system

from a German facility and incorporated in to a new release.

. Facility liaison for the implementation of Lean Manufacturing;

including facilitator of 8 Kaizen events, resulting in a cycle

time reduction of 54%, WIP reduction of 43% and 17% reduction in

Standard cost.

. Team co-leader in the closing of a facility and moving product

and process to three other facilities

Manager Process Development

1993-1996

. Managed two engineers, two tool designers and 8 toolmakers for

the support of manufacturing facility and process enhancements

. Developed a program to automate / semi-automate the facility

through the use of PLC's; developed a training program on the

use and programming of PLC's for engineers and toolmakers

. Developed a hydro-forming process for the fabrication of

specialty shaped tubing, resulting in $400k in annual savings.

. Developed a quick change protocol for the CNC machining centers

resulting in 1.5 hour set up reduction

Manufacturing Engineer / Toolroom Supervisor 1985 -

1993

. Responsible for the technical support of the rigid and semi-

rigid optical assemble, and CNC programming process development

. Responsible for managing the operation of an 8 person toolroom

over two shifts

. Redesigned a family of rigid telescope resulting in reduction

in standard cost of $80 per unit resulting in an annual savings

of $250K

. Managed the capital acquisition of a family of new products

which included over 350 different pieces of tooling and gauges

with a capital budget of $800,000.

The Nippert Company Delaware, Ohio January 1981 - March 1985

Cold forming company in the cold forming, drawing and machining of parts

from oxygen free copper for the use in the electronics industry.

Process Engineer

. Responsible for customer quotation of all custom parts

. Responsible for the floor support of the custom part department

involving high speed multi-station forming machines, hydraulic

press, and high speed screw machines

. Responsible for new part introduction, including tool

acquisition as needed

. Developed a manufacturing line to produce a family of welding

electrodes for the use in robotic welding.

Design Engineer

. Responsible for the designing cold forming dies and punches for

use in high speed multi station cold forming and hydraulic

presses.

. Responsible for the design of screw machine cams and specialty

cutting tools

. Developed a computer program to calculate the required press fit

between inserts and case used in cold forming.

Education

. Ashland University - M.S. Business Administration -1993

. University of Toledo - B.S. Mechanical Engineering - 1990

. Seminar - Lean Manufacturing

. Seminar - Advanced Supervisory Skills

Community and Associations

. Life Member The Ohio State Alumni Association

. Senior Member Society of Manufacturing Engineers

. Private Pilot

. Member AOPA

. Member of the United Fund Allocation Committee

. Workforce Incentive Act (WIA) Board Member

. Fundraiser Reach Our Youth (ROY)

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