Delivering reliable knowledge and trusted, professional design experience in the global medical device industry—specializing in medical device product labeling and packaging artwork development, design and production implementation

Global Labeling Operations, Labeling Project Leader
Baxter International, Inc.
Valletta, Malta (worked remotely from Huntington Beach, California, USA)

• Global Labeling Operations, Labeling Project Leader responsible for leading all project activities related to the design, development, execution and production implementation of medical device product labeling and packaging in compliance with 1) corporate standards, process and procedure and 2) domestic and international regulatory bodies and industry standards

Labeling Project Associate
Baxter Healthcare Corporation
Irvine, California, USA

• 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 1) corporate standards, process and procedure and 2) international regulatory bodies and industry standards
• Lead labeling designer and labeling project coordinator responsible for the successful implementation of 11 new, market-specific INFUSOR System Patient Guides
• Lead labeling designer and labeling 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 labeling 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 labeling 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 Healthcare Corporation
Irvine, California, USA

• Partnered with the Irvine Quality Manager to train 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 EU MDD standards for all product labeling and packaging for the INTERMATE and INFUSOR Systems 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 Irvine plant Change Control Board and all related Change Control activities at the plant

Drafter Specialist
Baxter Healthcare Corporation
Irvine, California, USA

• Lead labeling designer and labeling 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, businesses and franchises, and their global markets, including USA, EU, Canada, Asia Pacific and Latin America; product lines included INTERMATE, INFUSOR, MULTIRATE INFUSOR, Regional Analgesia INFUSOR with Patient Control Module, 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 responsible for all artwork, specifications and drawings used to produce all product labeling and packaging used at the Irvine facility
• Lead labeling designer responsible for the development and design of all INFUSOR LV System product labeling and packaging in 23 languages
• Lead documentation coordinator responsible for the successful implementation of the TeamCenter Product Lifecycle Management system at the Irvine facility
• Lead labeling designer and labeling 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
• 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 (all labeling and sub-assembly operations previously transferred from Round Lake to Swinford were later transferred to Irvine)
• Supervisor responsible for the Baxter Irvine Quality Design Services department with a staff of 2–6 CAD, documentation, labeling and design employees
• 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
• Supported the successful relocation of the Baxter Infusion Systems Division operations from Huntington Beach to the Baxter Irvine facility

Contract Design Drafter
Baxter Healthcare Corporation
Huntington Beach, California, USA

• Partnered with the Baxter Round Lake Documentation function to convert all ISC documentation to Baxter standards and implement the Baxter documentation system at the Huntington Beach plant
• Partnered with an engineering specialist to implement the computer-aided design drafting (CADD) function at the Huntington Beach plant

Contract Design Drafter
Infusion Systems Corporation (ISC)
Huntington Beach, California, USA

• Partnered with an engineering specialist to develop, design and implement the mechanical design and drafting function responsible 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, implement and lead the ISC product design and documentation functions
• Partnered with an engineering specialist to develop, implement and lead the ISC product labeling and packaging design function
• Partnered with an engineering specialist to develop, design and implement all product labeling and packaging for the INTERMATE 100 Elastomeric Infusion System
• Partnered with an engineering specialist and a team of engineers to produce and release the first INTERMATE 100 Elastomeric Infusion System to market

Contract Design Drafter
McGaw Laboratories, Bentley Laboratories, American Medical Optics and Coopervision Systems
Irvine, California, USA

• McGaw Laboratories: Drafting of injection molded parts used in production of medical equipment
• Bentley Laboratories: Drafting of injection molded parts used in Bentley Artificial Respirator
• American Medical Optics: Design drafting of surgically implanted intraocular lenses; worked from engineer’s concepts of doctors’ custom requirements
• Coopervision Systems: Designed components used in the production of intra-ocular surgical lasers

• New Horizons Learning Center, Anaheim, California, USA: Excel, Illustrator, InDesign, Paradox, QuarkXPress
• Baxter Healthcare Corporation, Irvine, California, USA: cGMP, Lean Manufacturing, Change Control Management, Train the Trainer, Corrective Action and Preventive Action
• Parametric Technology Corporation, Newport Beach, California, USA: Pro/ENGINEER
• California State University, Fullerton, California, USA: Solid Modeling Using PTC Pro/ENGINEER
• Santa Ana College, Santa Ana, California, USA: ComputerVision Personal Designer

• Orange Coast College, Costa Mesa, California, USA: Drafting and Design Technology