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Senior Label Designer (Medical Device)

Company: Stryker Corporation
Location: Portage
Posted on: May 3, 2021

Job Description:

We have a great opportunity for a Senior Label Designer to join our dynamic team! This role is responsible for development and maintenance of medical device labels for a variety of Stryker products. The Senior Label Designer will collaborate with product SMEs to assess and gather content and is responsible for execution of label format and content compilation using specialized software. This role partners with hospital and healthcare facility staff in global markets. Labels must be compliant with regulations, standards, and business requirements therefore attention to detail is essential and a high caliber of collaboration skills and customer focus is needed.

What you will do:

  • Collaborate with product SMEs to assess and determine label requirements and content: Regulatory Affairs, Product Development, Product Safety Engineers, Packaging Engineers, Clinical Sciences, Marketing, Trade Compliance, etc.
  • Participate in new product label planning meetings and capture requirements using quality system planning documents.
  • Design label formats for functional usability by healthcare staff
  • Use specialized labeling software to generate label templates and enter label data, text, and graphics into database for print-on-demand label system
  • Use desktop publishing software to design labels produced by external suppliers
  • Ensure barcodes pass verification testing
  • Select appropriate label materials
  • As needed, support label translation strategies that satisfy international labeling needs
  • Support multiple simultaneous labeling projects for new products, mergers and acquisitions, and label maintenance
  • Perform troubleshooting of electronic files as needed
  • Review labels for completeness and presentation
  • Contact external suppliers to resolve label output details
  • Manage labels in PLM/CMS system for controlled label releases and revision management
  • Manage work to meet project milestones
  • Inform project managers of relevant aspects of language translation process such as requirements, costs, and timelines
  • Communicate impact of language translation for alignment with project timelines and cost
  • Initiate/assist with departmental continuous improvement endeavors
  • Collect and track data/metrics associated with projects
  • Provide reviews of regulatory documentation to ensure that medical device labeling references are complete, correct and compliant with FDA, EU and any other applicable requirements
  • May assist with regulatory audits
  • Submit reports as requested by manager

What you will need:

  • Bachelor's Degree in Data Management, Graphic Design or related industry
  • 2+ years equivalent experience
  • Experience with regulatory compliance for medical devices or pharmaceutical labeling is required
  • Experience with a rigorous change management process
  • Detail orientated with the proven ability to multitask and manage multiple simultaneous projects
  • Strong organizational and time management practices
  • Excellent problem solving and analytical ability
  • Independence in carrying out assigned tasks
  • Excellent written and verbal English communication; knowledge of non-English language could be an asset but is not required
  • Interest in language translation and international communication
  • Able to communicate with international customers
  • Understanding of impact of language translation to format design
  • Preferred experience navigating challenges related to language
  • Ability to work under pressure in a sometimes fastpaced environment.
  • Highly developed computer skills and able to quickly learn new software
  • Experience working with/entering data into data-driven software
  • Experience with Prisym ID, Prisym 360, Adobe Illustrator, WindChill is preferred
  • Experience with external service suppliers

Keywords: Stryker Corporation, Portage , Senior Label Designer (Medical Device), Other , Portage, Michigan

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