Engineer Technician III

EUMDR Labeling Graphic Artist II 
 This is a 6 month temporary assignment that may be extended. 
 Job summary: 
 Utilize Graphic, Labeling and Barcode software to develop labeling and packaging for Image Guided Therapy (IGT) devices in accordance with GMP’s, FDA Regulations, EUMDR, ISO Requirements and Standard Company Operating Procedures. Knowledge of EU MDR 2017 and 13485:2016 Regulations is preferred. 
 - Develop and maintain Instruction For Use (IFUs) documents, including product illustrations, layout design, and illustrative material and copy. 
 - Utilize existing templates in programs including, but not limited to, Bartender, Adobe LiveCycle and EnLabel to create or revise labeling artwork and content based on corporate graphic standards, procedures and/or previously established formats. 
 - Use of PLM (Windchill) for document control process to route all work for approval 
 - Perform prepress activities necessary to prepare labeling artwork files for accurate output. 
 - Prepare and route labeling packages for 1st article and approvals. 
 - Proofread labeling artwork utilizing measurement, inspection tools (e.g. rulers, barcode scanner, etc.) and related documentation. This is a quality role in medical devices which focuses on a first-time right approach. Attention to detail with minimal errors is key. 
 - Reviews and updates as necessary to ensure proper revision control and storage of all labeling. 
 - Establishes and cultivates a network of support (manufacturing, engineering, regulatory, legal, product development and marketing) to facilitate completion of labeling and artwork assignments. 
 - Maintains and follows proper compliance and quality system requirements. Ensures proper documentation is prepared and corrected to reflect continuous improvement activities that lead to new or improved processes. 
 Bachelor's Degree or equivalent 
 Skills and Abilities: 
 • Proficient in Adobe Creative Suite 
 • Proficient in Microsoft Office 
 • Literate in Adobe Lifecycle preferred 
 • Literate in Bartender, EnLabel, Windchill and SAP preferred 
 • Excellent written and verbal communication skills. 
 • Ability to exercise independent judgment consistent with company policy 
 • Ability to organize and prioritize workflow 
 • Ability to interact with all levels of employees including senior management 
 • Ability to navigate through PC desk top, computer drives, directories, folders, applications, etc. 
 • Ability to adapt to changing processes and learn programs quickly 
 • Strong attention to details is critical 
 Problem Solving and Decision Making: 
 • Work is performed under minimal supervision; work is reviewed for accuracy 
 • Ability to anticipate needs and take ownership of tasks with minimal errors 
 Physical Requirements: 
 • Sitting for extended periods of time in front of a computer as well as those necessary to perform the job duties listed above 
 Supervisory Responsibility: 
 • None 

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