Les underwood

**** ******** ***** ( Bedford, TX 76021 ( abtwj0@r.postjobfree.com

( 817-***-****

Healthcare field with experience in medical device development, quality

management, and document maintenance.

SUMMARY OF QUALIFICATIONS

. FOUR YEARS OF PRIOR EXPERIENCE DESIGNING AND DEVELOPING DISPOSABLE

HEALTHCARE DEVICES AND OTHER VARIOUS MEDICAL PRODUCTS.

. Demonstrated ability to create, maintain and update medical and

administrative documentation in an accurate and thorough manner.

. Maintain awareness of ongoing technological advances in the medical

industry by attending various medical conferences.

. Familiar with Medical Device Directive 93/42/EEC, 21 CFR Part 820 and ISO

13485 standards, as related to process design.

. Adept at remaining poised and productive within fast-paced, chaotic

environments with constantly

shifting priorities.

. Proficient in Microsoft Word, Excel, Outlook, PowerPoint, Visio,

Solidworks and Windows, with a proven capacity for adapting rapidly to

new technologies.

Professional Experience

MECHANICAL ENGINEER

SEPTEMBER 2012- PRESENT

Flextronics inc.

Plano, TX

A socially-responsible, global leader in design, manufacturing,

distribution and aftermarket services.

. Facilitate design of commercial and industrial electro-mechanical

products using Solidworks.

. Worked on various areas of mechanical design for food and beverage

components. These components include injection molded plastic parts

and machined parts. Worked with design teams including electrical

engineers, software engineers, industrial design, purchasing, and

manufacturing.

. Verify product designs are met through NSF/ANSI 173 standards.

. Perform beverage qualification testing as (Brix Stratification,

Beverage Crossover, Carbonated Pressure and Foam testing).

. Create MPI's (manufacturing process instructions) for various electro-

mechanical products.

. Create ICI's (inspection checkpoint instructions) for quality

inspection of critical areas of the product before being shipped to

the customer.

Quality manager

June 2011- August 2012

Nurse Assist Inc.

Fort Worth, TX

Medical device manufacturer of products that help improve the quality of

care and quality of life for institutionalized patients or residents.

. Lead the quality organization of 4 people (1 supervisor and 3

individual contributors) of daily quality functions over a (3 shift

operation).

. During audits, I have experience representing my company as a lead

guide with FDA and BSI during the product certification processes

and during routine audits. Under my leadership; I was able to satisfy

a previous 483 observations and warning letter. We have always

received and maintained ISO13485 and CE marking certifications.

. Conduct testing and quality control to ensure development of safe,

reliable medical devices and fluid products.

. Generate and prioritize detailed records of Bioburden and Quarterly

Dose Audit reports to document compliance with FDA and industry

regulations and ISO 13485 standards.

. Perform on-site supplier audits used as a primary decision tool,

whether to continue pursuing a business relationship with each

supplier.

. Implement and managed a Quality System, including procedures and

practices.

. Quality System Projects: conduct quarterly internal audits for all

departments, conduct annual management review, initiate material

review boards, implementing design controls, establish quality

objectives, validations of IQ/PQ/OQ (e.g. Injection Blow Molding, Lube

Gel Filling Equipment, Amsino 10cc Syringes), initiated and manage

multiple CAPAs, revalidation of ETO sterilization, conduct employee

training for QP/SOP and Bi-Annual competency training, and annual

equipment calibrations.

. Perform daily verifications for Bioburden, Endotoxin, USP water, Heavy

Metals, Ph testing reports to ensure post-sterile specifications of

saline and sterile water products are met before releasing to the

customer.

. Research to analyze the rework levels associated with variances

occurring in the syringe assembly machines, processes, and operators

to help identify the rework levels related with those factors to help

sustain a better control rework percentage.

Medical r&D engineer/Quality Assurance August 2008- April 2011

mentor corp (johnson & johnson Inc.) Irving, TX

Worldwide supplier of medical products for the aesthetic medicine market.

. Facilitate design and development of disposable medical equipment, breast

implants, and manage full project life cycle from concept to completion

using Solidworks.

. Restructured technical files for all medical equipment for BSI

certification.

. Steered design and assembly of and co-authored patent for new disposable

cannula product line.

. Conduct testing and quality control to ensure development of a safe,

reliable product.

. Generate and prioritize detailed records of technical files to document

compliance with FDA and industry regulations and ISO 13485 standards.

. Interact and negotiate successfully with suppliers and vendors, assist in

determining financial cost of new projects, and author product manuals.

Mechanical design engineer February 2008- June 2008

Universal display & fixtures Lewisville, TX

Manufacture of display fixtures for retail merchants

. Performed full life cycle design and development of display products

using Solidworks.

mechanical design engineer December 2004- January 2008

chelton inc. Lewisville, TX

An international defense supplier for high frequency radio antenna and

satellite receiver systems.

. Performed full life cycle design and development of mechanical products

using Solidworks.

. Initiated design and assembly of a groundbreaking new product line,

leading to a multi-million dollar military contract.

. Interfaced with vendors to gather product information and acquire price

quotes in order to structure financial budgets for upcoming projects.

. Collaborated with electrical engineers in designing test tools for new

product qualifications.

. Drafted thorough and accurate product instruction and assembly manuals.

*Over twenty years of prior experience in the engineering industry*

Education

M.A. - HEALTH CARE ADMINISTRATION 2011

ashford university Clinton, IA

? Member, Golden Key International Honour Society, 2010.

b.a. - organizational management/business administration 2009

ashford university Clinton, IA

? Graduated Summa Cum Laude ? Member, Alpha Sigma Lambda National

Honor Society, 2009.

B.S. - Mechanical ENGINEERING

2005

KENNEDY-WESTERN UNIVERSITY

Cheyenne, WY

Professional associations

. MEMBER, AMERICAN COLLEGE OF HEALTHCARE EXECUTIVES (ACHE), 2009-PRESENT.

. Member, American Society for Quality (ASQ), 2012

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