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Director of Engineering

Location:
Lancaster, PA
Posted:
January 31, 2015

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Resume:

Engineering Manager

Seeking senior engineer or engineering manager position in a new product

development and manufacturing environment. Broad industry knowledge and

experience with design, development and manufacturing including

documentation control, process validation, quality systems and six sigma

methodologies.

Skills/ Expertise

. Twenty-five years medical device product realization experience within

ISO13458 and 21CFR820 quality system regulations. Preparation of 510(K)

submissions, Technical Dossiers, Design History Files, Device Master

Records

. Six sigma green belt certification, operational excellence

. Broad knowledge of manufacturing processes common to disposable medical

devices; plastic injection molding, ultrasonic welding, thermoform

packaging, form grinding, swaging, metal stamping, passivation, washing,

wire EDM, laser welding, laser marking, hypodermic needle pointing, pad

printing, automated and manual assembly

. Solidworks viewer, Minitab, MS Office suite, Visual MRP, Master Control

software documentation administration

. Leadership; three years and counting leadership transformation.

Discovering and practicing several leadership distinctions. Proven

ability to lead in the challenging and dynamic environment of custom

contract manufacturing

Professional Summary

Precision Medical Products, Denver, PA 2004-2014

Full Service medical device contract manufacturer, 100 employees

Director of Engineering

. Fostered and coached a close knit team of project managers, process

engineers, machinists, automation technicians, process validation

specialists, project coordinators and document administrators. Fourteen

to twenty people strong, together we made proposals, quoted and brought

dozens of complex products through the medical device product realization

process for large, established clients and start-up virtual companies

. Established client relationships on a technical level

. Prepared and directed proposals, quotes and brought dozens of complex

products through the medical device product realization process for

large, established clients and start-up virtual companies

. Responsible for developing and integrating the manufacturing of over $6MM

in highly differentiated new product sales over the span of six years

. Purchased and integrated over $2MM in new manufacturing equipment to

replace antiquated equipment; laser welder, laser marker, laser cutter,

ultrasonic welders, ultrasonic RO wash system, high energy deburring,

injection molding presses, Multivac form, fill and seal line with

integrated fill module designed in-house. Recognized the need and helped

develop an in-house custom automation team to address rapid deployment of

custom assembly automation

. Entrusted with millions of client funds to develop processes and tooling

for custom products. Developed an NRE hour and expense tracking system

using a conventional Microsoft Office Access database

. Helped grow customer base from five to over twenty. Many new product

opportunities were repeat clients

. Established quality system guidelines and had direct accountability for

documentation development and administration. Worked closely with IT to

provide documentation and training solutions within Master Control

documentation control software and Visual MRP software

. 95% overall customer satisfaction rating on new project deliverables

across five years of tracking

Kimberly Clark healthcare/ Ballard Medical Products; Milpitas, CA/

Pocatello, ID and Salt lake City, UT 1996-2004

Kimberly-clark healthcare is a multi billion dollar corporation

specializing in surgical non-wovens and disposable medical devices

Sr. Project Manager and New Product Development Engineer

. Responsible for all aspects of bringing minimally invasive accessories to

market. 510(K) pre-market approval submissions and CE technical

dossiers. Developed the Dilacath biliary dilatation and stone

extraction balloons, biliary stents, biopsy forceps, paracentesis kits

. Mergers and acquisitions; spent a period of one to two years performing

due diligence and integrating small, synergistic companies into the

manufacturing facility in Pocatello, Idaho. Once integrated the

acquisitions established almost $4MM in endoscopy product line sales

which quickly grew to over $5MM after new line extensions and

introductory products coordinated by my team.

. Provided a facelift and branding features to consolidate and give

products the same "look". Re-designed features to allow more robust

assembly processes and cost savings of more than $100,000 per year

. Developed work instructions, process validations and other quality system

initiatives

. Eight design patents awarded in the field of minimally invasive,

endoscopic catheters and accessories

Arrow Precision Products, INC; Reading, PA 1991-1996

Full Service medical device contract manufacturer, 30 employees

Project Engineer

. Worked with Sr. process engineers to develop and manufacture disposable

medical device products for clients. Focused on auto-injectors and

ophthalmology products

. Designed disposable G.I. endoscopy accessories and the first multilumen,

biliary catheters on the market.

. Wrote three successful 510(K) pre-market notification submissions for

products I helped design and manufacture resulting in $.5MM in sales

. Developed work instructions, process validations and other quality system

initiatives. Worked closely with manufacturing associates on training

and quality issues in a union environment

EDUCATION

Master of Business Administration, Westminster University, Salt Lake City,

UT 2003

Master of Science, Mechanical Engineering, Drexel University, Philadelphia,

PA 1993

Bachelor of Science, Mechanical Engineering, Pennsylvania State

University, State College, PA 1990



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