Nolen Elam Design

NED

NAME
Nolen (‘Ned’) Elam

EMAIL
nolen.elam@yahoo.com

WEB
nolenelam.com

LINKEDIN
linkedin.com/in/nolenelam

LOCATION
Costa Mesa, California

Nolen_(Ned)_Elam.jpg

Medical Device Labeling and Packaging Design Professional

Proven mastery in creating, designing, developing, writing, editing and implementing:
  • Medical device product labeling and packaging artwork designs
  • Technical documents, drawings and illustrations
  • Mechanical design drafting
  • Vector-format graphics
  • Raster-format images
  • Material specifications, SOPs, manuals, forms and job aids
Expert fluency in industry-standard applications:
  • Adobe Creative Cloud
InDesign
Illustrator
Photoshop
Acrobat
  • Microsoft Office
Word
Excel
PowerPoint
Project
Outlook
Effective leadership in supporting related business systems:
  • Project management, from concept to production
  • Cross-functional teams, local and international
  • Supplier relations
  • Supply Chain
  • Change Control
  • Documentation
  • Manufacturing labeling and packaging printing processes
  • Quality
  • Incoming inspection
Delivering 32 years of reliable knowledge and trusted, professional experience serving in the medical device industry—specializing in medical device labeling and packaging development, design and implementation!

Experience

Labeling Project Associate
Baxter International Inc.
January 2014 – Present (3 years, 8 months)
Irvine, California

  • Lead Labeling Project Associate at the Baxter manufacturing facility in Irvine, responsible for the design, development and production implementation of medical device product labeling and packaging in compliance with corporate standards, process and procedure; and in compliance with domestic and international regulatory bodies and industry standards
  • Lead labeling designer and project coordinator responsible for the successful implementation of 11 new market-specific INFUSOR System Patient Guides
  • Lead labeling designer and project coordinator responsible for the successful implementation of UDI barcode standards on BAXJECT and FLOWEASE product labeling in compliance with new US market requirements mandated by the US FDA
  • Lead labeling designer and project coordinator responsible for the successful conversion of all BAXJECT and FLOWEASE product labeling and packaging from Baxter to Baxalta (now Shire)
  • Lead labeling designer and project coordinator responsible for the successful remediation of all product labeling and packaging for the INTERMATE and INFUSOR System product lines

Documentation Associate II
Baxter International Inc.
March 2007 – January 2014 (6 years, 11 months)
Irvine, California

  • (2013) Partnered with the Irvine Quality Manager to train Irvine staff to use the new change control management system based on TrackWise
  • (2010) Lead labeling designer and project coordinator responsible for the successful implementation of new EU MDD standards for all product labeling and packaging for the INTERMATE and INFUSOR System product lines
  • (2009) Lead labeling designer and project coordinator responsible for the successful implementation of all product labeling and packaging for the new FOLFusor System product line
  • (2009–2012) Managed the Irvine plant change control board and all related change control activities at the plant

Drafter Specialist
Baxter International Inc.
February 1990 – March 2007 (17 years, 2 months)
Irvine, California

  • Lead designer and project coordinator responsible for the successful implementation of all product labeling and packaging used by over 125 medical device product codes manufactured by the Baxter Irvine facility for multiple divisions/franchises and their global markets, including USA, EU, Canada, Asia Pacific and Latin America; products include INTERMATE, INFUSOR, MULTIRATE INFUSOR, Regional Analgesia INFUSOR, Patient Control Module, DUPLOREACH, DUPLOJECT EASY PREP, COSEAL and FLOSEAL
  • Lead design drafter responsible for creating, revising, managing and maintaining all CAD drawings used at the Irvine facility
  • Technical approver/subject matter expert for all artwork, specifications and drawings used to produce all product labeling and packaging used at the Irvine facility
  • (2004) Lead labeling designer responsible for the design of all INFUSOR LV System product labeling and packaging in 23 languages
  • (2003) Lead documentation coordinator responsible for the successful implementation of the TeamCenter Product Lifecycle Management system at the Irvine facility
  • (1995–1997) Lead labeling designer and project coordinator responsible for the successful implementation of the CE Mark on all Irvine product lines (INTERMATE, INFUSOR, Patient Control Module) in compliance with EU MDD and ISO standards
  • (1994–1999) Lead labeling designer and documentation coordinator responsible for the successful transfer of the INFUSOR System product line and all associated documentation, labeling and CAD drawings from Baxter Round Lake to Baxter Irvine and from Baxter Swinford to Baxter Irvine (labeling and sub-assembly operations previously transferred from Round Lake to Swinford were later transferred to Irvine)
  • (1994–1997) Supervisor of the Baxter Irvine Quality Design Services department with a staff of 2–6 documentation and design employees
  • (1992–1994) Lead documentation coordinator responsible for the successful implementation of the Baxter change control system at the Irvine facility, including the conversion of all Irvine documentation to comply with Baxter corporate standards

Contract Design Drafter
Baxter International Inc.
July 1988 – February 1990 (1 year, 8 months)
Huntington Beach, California

  • Partnered with an engineering specialist to develop, design and implement all product labeling and packaging for the INTERMATE elastomeric infusion system
  • Partnered with an engineering specialist to develop, implement and lead the product labeling and packaging design function
  • Partnered with an engineering specialist to implement the computer-aided design drafting (CADD) function

Contract Design Drafter
Infusion Systems Corporation
May 1985 – July 1988 (3 years 3 months)
Huntington Beach, California

  • Partnered with an engineering specialist to develop, design and implement the mechanical design drafting function for the production of all injection molded parts used by the INTERMATE elastomeric infusion system product line developed, designed and manufactured by ISC
  • Partnered with an engineering specialist to develop and implement the ISC design and documentation functions
  • ISC was purchased by Baxter in July 1988

Courses

New Horizons Learning Center, Anaheim, California: Excel, Illustrator, InDesign, QuarkXPress

Baxter Healthcare Corporation, Irvine, California: cGMP, Lean Manufacturing, Change Control Management, Train the Trainer, Corrective Action and Preventive Action

Parametric Technology Corporation, Newport Beach, California: Pro/ENGINEER

California State University, Fullerton, California: Solid Modeling Using Pro/ENGINEER

Santa Ana College, Santa Ana, California: Personal Designer

Education

Orange Coast College, Costa Mesa, California
Drafting and Design Technology

Skills

Medical Device Product Labeling and Packaging Design
Product Labeling and Packaging Artwork Design
Labeling Design
Packaging Design
Page Layout
Technical Illustration
Vector Illustration
Image Editing
Adobe InDesign
Adobe Illustrator
Adobe Photoshop
Adobe Acrobat
Adobe Creative Cloud
Adobe Creative Suite
QuarkXPress
Apple macOS
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Microsoft Project
Microsoft Office
Microsoft Outlook
Microsoft OneNote
Microsoft SharePoint
Microsoft Windows
Project Management
Project Planning
Project Timelines
Timeline Development
Change Control Management
Documentation Management
Documentation Systems
Technical Documentation
Mechanical Drafting
Mechanical Design Drafting
Mechanical Drawings
Design Drafting
Material Specification Development
SOP Development
TeamCenter Product Lifecycle Management
TrackWise
TeamCenter
CE Mark
EC MDD
FDA
ISO
UDI
Barcodes
Label Redlining
Document Redlining
GlobalVision Docu-Proof
GlobalVision Scan-TVS
Electronic Proofreading Systems
Lean Manufacturing
Team Leadership
GMP
GDP


Nolen last updated this page 8/4/17. Check back for updates. Connect with Nolen by Email or LinkedIn.