Location: Plymouth, MN
Duration: 6 months

POSITION DESCRIPTION:

This position has the responsibility and authority to develop and maintain including but not limited to product user manuals, Instructions for Use (IFU) documents, device and packaging labeling, and technical service documentation. You will take the initiative to identify document requirements, interview subject matter experts, regulatory affairs specialists, and marketing managers to obtain the necessary product requirements and information, and distill this information into detailed, accurate, and professional documentation. You will complete, route through approval cycles, and follow through with electronic forms required to release documents and collaborate with multiple functional areas to ensure accurate and compliant labeling and documentation are included with the products they describe. You will present complex concepts clearly and concisely, manage multiple projects concurrently, adjust priorities frequently, and overcome obstacles to meet deadlines.

POSITION RESPONSIBILITIES:

  • Identify IFU requirements and obtain necessary raw information from various sources.
  • Learn and understand the design and behavior of the company’s products.
  • Design, develop, and maintain in accordance with corporate branding and visual identity standards.
  • Control documentation and labeling versioning and maintain the IFU archives.
  • Provide documentation and labeling-related support to the Marketing, Product Development, and Regulatory Affairs groups.
  • Identify IFU translation requirements, develop materials conducive to efficient translation and localization, and prepare and manage translation projects to completion (working with localization/translation service providers).
  • Perform the administrative documentation tasks required to establish and track IFU in a Product Lifecycle Management system.
  • Work closely with the Technical Service team and subject matter experts to develop technical service manuals, procedures, forms, reports, and other documentation as required.
  • Continuously evaluate business processes, identify improvement opportunities, and implement improvements.
  • Proofread and edit the work of other writers.
  • All activities must be performed in compliance with the Quality System.
  • Performs duties in compliance with environmental policies, health and safety related site rules, or governmental regulations.
  • All other duties as assigned.
  • Travel requirement: Less than 10%

REQUIREMENTS:

  • B.S./B.A. English, Communications, or Journalism or degree in a related field or equivalent work experience.
  • 2+ years of technical writing or technical editing experience in a technical publications group.
  • 2+ years experience working in a medical and regulated environment
  • 0+ years experience with a Master’s Degree.
  • Demonstrated audience-sensitive document design and outstanding writing skills are essential
  • Proficient copyediting and proofreading skills
  • Strong writing, grammar, and punctuation skills; ability to type quickly and accurately by touch
  • Strong verbal communications skills
  • Demonstrates strong mechanical understanding and the ability to conceptualize mechanical or physical processes
  • Proficient in management of time and resources within project schedule or budget constraints
  • Function in the capacity of lead technical writer on projects, coordinating the work of graphics developers or other technical writers
  • Proficient problem solving skills
  • Pleasant to work with, and able to develop and maintain good relations with co-workers
  • Create and maintain templates for user documentation and labeling materials, such as operating documents, training guides, and job performance aids.

PREFERRED QUALIFICATIONS:

  •  Coursework or experience in electronics, biology, anatomy and physiology, or medicine
  • Experience with translation projects and/or experience in an international organization
  • Ability to adapt new technologies and tools and methodology changes
  • Proven ability and experience working with subject matter experts Proven people and communications skills
  • Proven attention to detail and excellent organizational skills
  • Proficiency with the Microsoft Office suite and the Adobe Creative Suite with specific experience and proficiency with FrameMaker, InDesign, Illustrator, and Photoshop.
  • Familiarity with regulatory requirements for medical device documentation, manuals and symbols

Click to submit a resume or find additional support.