Medical Device Manager

Laura Williams

*** ************ ****, *******, ** 29631

Phone: 864-***-**** e-Mail: ab3eum@r.postjobfree.com

Education

MS, Packaging Science, Clemson University Graduating August

2013

BS, Business Administration and Marketing, Greensboro College December 1988

AS, Health Science, Greenville Technical College

December 1995

Software Skills/Knowledge

• Artios CAD, TOPS, CAPE,

Kongsberg XL44/XP, Share Point, Mindjet Mind Manager, Minitab, Smart Scope/Measure-X, RAM

Optical/eBX, MS Office, Power Point, Excel, Eagle Soft, Schick Digital

• Plotter-Cutter Table, Extrusion/Lamination/Cast/Blown Film Lines, Injection and Extrusion

Blow Molding techniques, Lean Manufacturing, Six Sigma, 5S, Poka-Yoke, ISO 11607-1, ASTM,

ISTA, and TAPPI standards, bar code symbology, understanding of manufacturing process and

customer distribution channels.

• Testing and analytical equipment such as Instron, spectrometer, colorimeter, water activity,

headspace analysis, pH meter, thickness gauge, blue-dye testing, vacuum leak tester, package integrity

testing, microscopic camera, distribution testing, package and equipment validation

Work Experience

Design/Project Assistant Temporary

Protective Packaging Solutions, design/fabricator Cincinnati, OH

• Custom design packaging components and case inserts for various devices, equipment and

products utilizing Artios Cad and various machinery

• Assemble packaging components for prototypes and samples for customers of various

industries and government contractors

• Independently design conceptual and re-work projects of various complexities and layers

• Assist with documentation including first articles, specs, drawings, BOM, quotes and shipping

• Materials selection including various types of foam, PE and paperboard corrugate, laminates

Packaging Engineer Co-op July-

December 2012

Ethicon Endo-Surgery, medical device and surgical instruments manufacturer Cincinnati,

OH

•

Designed, tested, and selected packaging materials including Tyvek®, HDPE, SBS, corrugate for

propriety medical devices

•

Took part in engineering team to redesign and validate rigid and flexible packages passing Quality and

Regulatory Control standards

•

Assisted with conceptual design of flexible packaging prototype development incorporating

thermoforming, heat sealing, blue-dye, ink rub, compression, and distribution testing within the scope

of ISO 11607-1 and ASTM standards

•

Identified outdated modification codes and updated GS1 labeling system.

•

Authored various Engineering studies and Protocols for New Product Development team

•

Developed and implemented Work Instructions and Test Methods for Packaging and Sterilization

Laura Williams 2 of 2

Department; also created work instructions for RAM Optical Instrument, Densometer, Kongsberg

44 Plotter/Cutter table and teamed with Safety Manager on equipment installation and

validation including calibration and Gauge Repeatability and Reproducibility

•

Directly impacted department by designing primary carton, secondary shipper, and tertiary box and

pallet arrangement while teaming with labeling department to design label and Instruction for Use

insert and meet label criteria for a new medical device product.

•

Developed a Packaging Systems Library utilizing an unused cubical creating storage and accessibility

of current and retired medical device packaging

•

Utilized various software as listed above

Graduate Research/Teaching Assistant June 2010-July

2012

Clemson University

Clemson, SC

• Managed a Medical Device and Healthcare Packaging course of 13 students which included

coordinating facilities tours, creative inquiry, and various projects related to consumer healthcare

and medical device packaging

• Acted as a liaison for the Packaging Science Department and Packaging Industry to research

projects and obtain materials from supporting companies such as Sealed Air for lamination and sealing

studies, package integrity testing of medical device packaging, and vegetable product research; Birds

Eye for comparison of gusseted versus non-gusseted pouches, Frito-Lay, USAID,

and “GoodOnYa” for shelf life research, Mars Petcare for texture and firmness analysis, and

Ingles for fresh vegetable research using modified atmosphere packaging

• Assisted in testing of open and closed foam for fragility study, beverage and consumer

personal care product bottles for distribution testing including cushion testing, drop testing, shock and

vibration testing

• Proctored exams and assisted various instructors providing faculty support.

• Led a university-wide event, “Bring Your Daughters to Clemson”, for the Packaging Science

Department

• Supervised and trained undergraduate students in the Packaging Science Lab and assisted with

analytical and thermal testing

Registered Dental Hygienist December 2004-

June 2010

Charleston and Greenville metropolitan areas South

Carolina

• Contractor for various dental practices using various proprietary software programs

• Performed fundamental tasks including dental cleanings, X-Rays, probing, and charting

• Administered local anesthesia and other medicaments

• Educated patients on oral health care and nutrition

• Schematized administrative systems and managed insurance claims

Awards/Technical Conferences/Organizations

• Recipient, Professional Enrichment Grant

• Recipient, Merit Scholarship

• HealthPack 2011/2012, CefPack, 2011/2012, NextPack 2012, PackExpo 2012

• Institute of Packaging Professionals, Member

• Institute of Food Technologists, Member

• Graduate Student Government, Senator

• Graduate Judiciary Advisory Board, Member

• Graduate Packaging Science Club, Representative

• Adult Literacy Volunteer

• United Way Volunteer

• Theater and Arts Association Volunteer

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