Nolen Elam Design

NED

NAME
Nolen (‘Ned’) Elam

E-MAIL
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

Summary

A proven record of 32-years’ professional experience in the medical device industry—specializing in medical device labeling and packaging development, design and implementation—mastering the following areas of expertise:

- Expert fluency using industry-standard applications: Adobe InDesign, Illustrator, Photoshop and Acrobat; QuarkXPress; Microsoft Word, Excel, Project, Outlook and SharePoint

- Creating, developing, designing and editing page layout, packaging and artwork designs using InDesign and QuarkXPress

- Creating, developing, designing and editing vector graphics for technical illustration, drawing and drafting using Illustrator

- Creating, developing, designing and editing high-resolution raster images using Photoshop

- Creating, developing, writing, implementing and revising technical documents, material specifications, Quality and Manufacturing SOPs, manuals, forms and job aids using Word

- Effective, comprehensive project management, from concept to implementation, using Project and Excel, involving cross-functional teams across local and international locations and facilities

- Leading cross-functional teams, effectively interacting with all levels of local and international organization to drive and develop product labeling content and design requirements

- Leading external supplier relations, partnering and interfacing with supplier representatives to develop product labeling design requirements and ensuring material production meets supply chain demands

- Change control and documentation management using enterprise-class change control management systems (TrackWise) and product lifecycle management systems (TeamCenter)

- Knowledgeable in printing processes and manufacturing processes for production of labeling and packaging materials

- Full professional proficiency in the English language, strong written and verbal communication skills, analytical, precise, articulate, highly organized, detail-minded, team-oriented, customer-focused

Experience

Labeling Project Associate (Quality)
Baxter International Inc.
January 2014 – Present (3 years 4 months)

- 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 (Quality)
Baxter International Inc.
March 2007 – January 2014 (6 years 11 months)

- Partnered with the Irvine Quality Manager to train all Irvine staff to use the new Baxter change control management system based on TrackWise

- Lead labeling designer and project coordinator responsible for the successful implementation of new EC MDD standards for all product labeling and packaging for the INTERMATE and INFUSOR System product lines

- Lead labeling designer and project coordinator responsible for the successful implementation of all product labeling and packaging for the new FOLFusor System product line

- Managed the Baxter Irvine change control board and all related change control activities

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

- 1990-2007 - Lead designer and project coordinator responsible for the successful implementation of all product labeling and packaging for over 125 medical device product codes manufactured by Baxter Irvine 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

- 1990-2007 - Lead design drafter responsible for managing and maintaining all Irvine CAD drawings

- 1990-2007 - Technical approver/subject matter expert for all Irvine artwork, specifications and drawings used to produce Irvine product labeling and packaging

- 2004 - Lead labeling designer responsible for designing the INFUSOR LV System product labeling and packaging in 23 languages

- 1999 - Lead documentation coordinator responsible for the successful implementation of the Baxter Product Lifecycle Management documentation system

- 1995-1997 - Lead labeling designer and project coordinator responsible for the successful application of the CE Mark to all Irvine products (INTERMATE System, INFUSOR System, Patient Control Module) in compliance with EC MDD and ISO standards

- 1994-1999 - Facilitated 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 - Quality Design Services department supervisor responsible for staff of 2-6 documentation and design employees

- 1992-1994 - Lead documentation coordinator responsible for the successful implementation of the Baxter change control system in Irvine, including the conversion of all Irvine documentation to comply with Baxter standards

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

- 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 (ISC)
May 1985 – July 1988 (3 years 3 months)

- 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 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, CA: Excel, Illustrator, InDesign, QuarkXPress

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

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

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

Santa Ana College, Santa Ana, CA: Personal Designer

Education

Orange Coast College, Costa Mesa, CA
Drafting and Design Technology/Technician, General
1977 – 1979

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 Project
Microsoft Office
Microsoft Outlook
Microsoft OneNote
Microsoft PowerPoint
Microsoft SharePoint
Microsoft Windows
Project Management
Project Planning
Project Timelines
Timeline Development
Change Control Management
Documentation Management
Documentation Systems
Technical Documentation
Mechanical Drafting
Mechanical Drawings
Design Drafting
Material Specification Development
SOP Development
TrackWise
TeamCenter
UDI
Barcodes
Label Redlining
Document Redlining
GlobalVision Docu-Proof
GlobalVision Scan-TVS
Electronic Proofreading Systems
Lean Manufacturing
Team Leadership


Nolen last updated this page 4/19/17. Check back for updates. Connect with Nolen by Email or LinkedIn.