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