Location: Eden Prairie, MN
Duration: 3 months (w/possibility of extension)
POSITION DESCRIPTION:
Research, plan, organize, and develop technical product literature (such as user’s guides, IFUs, and product labels) by working closely with Engineering (software, electrical, mechanical, systems), Project and Program Management, Regulatory, Design Assurance, Quality, Training, Marketing, and Legal departments.The customers and clients for this technical literature include physicians, nurses, hospital technicians, as well as sales, marketing, and technical support personnel.

Manage translations of technical product literature and work with software engineers to localize software. Develop translation glossaries and translation reference materials to aid the translation process.

Primary Duties and Responsibilities:

Develop and maintain technical communications:

  • Research products by studying the product specifications, interviewing subject matter experts, using prototype hardware and software.
  • Research, plan, write, edit, and coordinate the development of required product literature in the appropriate timeframes for product launch and in compliance with company operating procedures and work instructions.
  • Ensure that product literature is consistent, clear, technically accurate, complete, and meets regulatory, marketing, and branding requirements.
  • Commit to a scheduled completion date. Inform management if schedule requires adjustment.
  • Support project teams by developing, communicating, and maintaining project estimates, schedules, and status.
  • Create and modify screen captures in required languages using Photoshop or PaintShop Pro.
  • Organize and facilitate content and quality reviews of assigned user guides and IFUs.
  • Edit documents, making technically and stylistically appropriate modifications.
  • Manage the change order release of product documentation and labels using Agile.
  • Update existing technical literature and labels as required.
  • Assist in the maintenance of internal systems and procedures to ensure consistency of format, style, clarity, safety, and technical accuracy.
  • Manage outside vendors such as illustrators, photographers, and printers, ensuring that they stay on schedule and within budget.
  • Peer review documents produced by other writers.
  • Other projects as assigned.

Manage language translations of literature and localized software user interface:

  • Define deliverables according to geographical requirements.
  • Work with outside translation services for all localization activities, including in-country reviews.
  • Establish and maintain translated glossaries.
  • Manage linguistic validations of software GUI.

Required Qualifications (Knowledge, Skills & Abilities):

  • BS or BA degree in Technical Writing, English, Communications, or a technical field with coursework in technical writing.
  • Previous technical writing experience in the medical device industry (5 years minimum).
  • Demonstrated ability to write clearly and concisely.
  • Expert level at using InDesign in creation of user guides, IFUs, and labels.
  • Proficient in Illustrator, Photoshop, and Acrobat.
  • Knowledge of medical device regulations as they relate to labeling requirements.
  • Experience using Agile software.
  • Experience with translation projects and working within an international organization.
  • Experience working with complex hardware and software systems and engineering teams.
  • Aptitude for new technologies and tools.
  • Experience with managing vendor relationships.
  • Demonstrated ability to manage multiple projects, sometimes with short or changing deadlines.
  • Excellent people and communication skills.
  • Excellent organization skills.
  • Attention to detail.

Preferred Qualifications

  • Project management experience.
  • Experience in medical technology and/or software end-user documentation.
  • Familiarity with electronic delivery on web sites and CD-ROM.
  • SGML, HTML, or XML authoring experience.

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