Documentation Specialist I

Fujifilm•Durham, NC

About The Position

The Documentation Specialist I assists in designing, developing, and maintaining high-quality technical documentation for medical technology products. The role supports the creation and updating of user manuals, online help systems, service manuals, troubleshooting guides, manufacturing and upgrade documents, and other materials tailored to different audiences. The specialist collaborates with subject matter experts across engineering, manufacturing, service, and project teams to gather information and translate technical specifications and data into clear, user-friendly documentation. Document reviews, records, documentation control, compliance processes, and continuous improvement of documentation standards and tools are performed with support and supervision as appropriate. The role must comply with applicable U.S. FDA medical device regulatory requirements, ISO 13485 requirements, and other applicable laws, regulations, and standards. The position includes occasional travel, typically up to 10–25% depending on business needs, and the physical demands described in the posting. FUJIFILM Healthcare Americas Corporation develops healthcare solutions across diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, and in-vitro diagnostics, and also provides non-destructive testing solutions.

Requirements

  • Bachelor’s degree in English, Technical Communication, Computer Science, or a related field.
  • Good verbal and written communication skills.
  • Ability to work collaboratively in a team setting and independently when assigned tasks.
  • Good organizational skills and attention to detail.
  • Willingness to learn rapidly and adapt to new technologies and industry standards.
  • Familiarity with the Microsoft Windows OS environment.
  • Ability to sit for 75–100% of the workday.
  • Dexterity to use hands and fingers to operate keyboards and other input devices up to 100% of the time.
  • Ability to stand, speak, and hear for up to 75% of the workday.
  • Ability to lift and carry up to 10 pounds up to 20% of the time.
  • Close vision capability to see clearly at close distances of 20 inches or less.

Nice To Haves

  • 0 to 2 years of experience in technical writing or a related discipline; internships or academic projects are valuable.
  • Basic understanding of technology, software development, or healthcare.
  • Familiarity with desktop publishing and authoring tools such as MadCap Flare or Adobe RoboHelp, or willingness to learn them.

Responsibilities

  • Assist in developing and updating user manuals and online help systems.
  • Assist in developing and updating service manuals and troubleshooting guides.
  • Assist in developing and updating manufacturing and upgrade documents, as well as other materials tailored to various audiences.
  • Collaborate with subject matter experts across engineering, manufacturing, service, and project teams to gather information.
  • Help translate technical specifications and data into clear, user-friendly manuals and procedures.
  • Support reviews of technical documents for accuracy and usability under supervision.
  • Maintain documentation records and assist with documentation control and compliance processes.
  • Participate in continuous improvement initiatives for documentation standards and tools.
  • Comply with applicable U.S. FDA medical device regulatory requirements, ISO 13485 requirements, and other applicable laws, regulations, and standards.
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