Location: Plymouth, MN
Duration: 12+ months

Position Description

Provide technical writing, project coordination, and documentation support for medical device product Instructions for Use documents. Users of this information include regulators, clinicians, and patients.  Candidates must be able to move quickly between projects while maintaining exceptional quality and have a technical aptitude for learning new tools and systems.  Candidates must have strong writing, design, and organizational skills as well as the ability to effectively communicate cross functionally.  Candidate must have strong attention to detail. Candidate must be able to work independently and effectively as part of a team.

Position Responsibilities

  • Plan, research, develop, and format content and materials (e.g., IFUs, registry forms, etc.)
  • Ensure worldwide labeling regulations, standards and business requirements are adhered to and internal quality system procedures are followed
  • Facilitate decisions about design, layout, branding, and usability
  • Put the labeling materials relevant to the project(s) into operation through engineering change orders
  • Build and maintain successful business partnerships
  • Creatively solve problems related to processes, systems, and tools
  • Exercise sound judgment in planning, organizing, performing, and coordinating work
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
  • Comply with all U.S. Food and Drug Administration (FDA) regulations, and those regulatory requirements from other countries, Company policies, operating procedures, processes, and task assignments
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
  • Performs other related duties and responsibilities, on occasion, as assigned

Basic Qualifications

  • BA/BS in Communications, Technical Communications, English, or related field
  • 0-2 years professional experience

Other Desired experience:

  • Content development using DITA, XML content management systems, and/or software such as FrameMaker, InDesign, Acrobat
  • Desktop publishing
  • Product Lifecycle Management (PLM) systems (e.g., Windchill)

 

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