Susanne Piche

Created or revised medical device artwork - Directions for Use, manuals, labeling and packaging. Also created new product labeling mockups and label designs for global use via PrisymMedica GLS system. Voted 'Employee of the Month' for the R&D department - Feb. 2014

(contract role) - Participated in the largest rebranding effort of Covidien products which ultimately affected over 34,000 pieces of artwork in the Medical Supplies and Vascular Therapies Global Business Unit.

Created or revised medical device artwork (contract role) - Directions for Use, manuals, labeling and packaging. Corporate Marketing, Publishing and Direct Mail Graphic Design - selected positions

(contract role) Created print marketing and sales collateral (including some supporting web components) for the Creative Services department.

(seasonal staff employee) Designed press-ready direct mail for clients such as Harvard, Berklee School of Music and University of Maryland.

TJX Corporation

CVS/Caremark Design and production of newspaper ads, billboards, postcards, in-store signage, large format posters, web banner ads and other marketing collateral.

Creates label design for projects of varying complexity through effective collaboration between label leads and requestors. Project timelines are met through effective teamwork within the labeling department and off-shore delegation. Proficient with Loftware, Adaptiv CO process and current procedures. Moderate proficiency with EnLabel design application.

Responsible for content creation and rebranding of instructions for use, patient literature and labeling for a recently acquired manufacturer's devices. On-site and remote position.

- Create new or revised graphic design for cartons, labels and other printed material to be used in R&D User Studies or Commercial packaging projects. Responsible for document management in GxMP environment. (consultant) Adobe Creative Cloud/PC.

UDI compliance project (contract role) - Revised existing content and designed new templates, adhering to brand standards and new UDI barcode requirements. Team commended for meeting all project goals -

Responsible for new and revised labeling deliverables (Instructions for Use included) through artwork and Change Request creation and routing. Also responsible for GUDID maintenance and overall Quality compliance regarding labeling content. Communicated effectively with internal and external stakeholders (vendors, the FDA and European representatives) regarding labeling projects and issues (ie: UDI and EU MDR). A self-starter who researched into ISO, MDD and MDR standards to ensure that compliance was met. Key accomplishments (besides day to day labeling updates): Initiated a company wide-initiative to direct mark sterile parts for UDI compliance to meet the FDA's original completion date. Brought 3 system and 16 instrument IFUs 'in house' for updates as part of my project load. This saved both time and budget resources as this was previously outsourced to a design agency. Gained understanding of Quality requirements of the MDR and communicated required responses to appropriate SMEs. Initiated meetings to facilitate a 'birds-eye' understanding of the MDR prior to obtaining outside help with Gap Analysis.

Production and design work, Sail, Saltwater * Alfred A. Knopf Publishing Sportsman and Technology Review magazines * Houghton Mifflin Publishing * White Flower Farm Catalogue - 3+ years of issues * Pennwell Publishing Company * Ingalls Advertising * Horizon House/Microwave * Cuneo/Silton/Turner Advertising * Fidelity Investments