Documentation Specialist I

FUJIFILM Biotechnologies; Durham (NC); On-site; USD 52,000 - 76,000; Full time

Job summary

FUJIFILM Healthcare Americas Corporation is seeking a detail-oriented technical writer to design, develop, and maintain high-quality documentation for medical technology products. Familiarity with desktop publishing tools like MadCap Flare is a plus.

Collaborate with engineers, manufacturing, service, and project teams to translate complex information into clear manuals and procedures. You will ensure accuracy, maintain records, and support compliance with FDA and ISO 13485 requirements while

Qualifications

• Bachelor's degree in English, Technical Communication, Computer Science, or related field.
• 0 to 2 years of technical writing experience preferred; internships or academic projects valuable.
• Basic understanding of technology, software development, or healthcare preferred.
• Familiarity or willingness to learn desktop publishing and authoring tools such as MadCap Flare or Adobe RoboHelp is advantageous.
• 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 Microsoft Windows OS environment.

Responsibilities

• Assist in developing and updating technical documentation including manuals and online help systems, service and manufacturing documents.
• 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 U.S. FDA medical device regulatory requirements, ISO 13485 and other applicable laws and standards.

Education

Bachelor's degree in English, Technical Communication, Computer Science, or related field

Tools

MadCap Flare

Adobe RoboHelp

Microsoft Windows OS

Job description

Position Overview

In this position, you must be creative and detail-oriented to assist in designing, developing, and maintaining high-quality technical documentation for our medical technology products. Familiarity with desktop publishing tools, such as MadCap Flare, is a plus but not mandatory.

Company Overview

At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier world, and we need passionate, driven people like you to help us get there. Our cutting-edge healthcare solutions span diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, as well as in‑vitro diagnostics.

But we don't stop at healthcare; our Non-Destructive Testing (NDT) team harnesses advanced radiography solutions to keep transportation infrastructure, aerospace, and oil and gas assets safe and running smoothly.

Ready to innovate, collaborate, and make a difference? Join us and bring your big ideas to life while working in a dynamic, flexible environment that fuels your creativity and drive.

Our headquarters is in Lexington, Massachusetts, an inspiring healthcare research hub in a historic town.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

Duties and responsibilities

• Assist in developing and updating technical documentation, such as:
  • User manuals and online help systems
  • Service manuals and troubleshooting guides
  • Manufacturing and upgrade documents
  • Other materials tailored for 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 all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards.

Qualifications

• Bachelor's degree in English, Technical Communication, Computer Science, or a related field.
• 0 to 2 years of experience in technical writing or a related discipline preferred; internships or academic projects are valuable.
• Basic understanding of technology, software development, or healthcare preferred.
• Familiarity or willingness to learn desktop publishing and authoring tools such as MadCap Flare or Adobe RoboHelp is advantageous.
• 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 Microsoft Windows OS environment.

Physical requirements

The position requires the ability to perform the following physical demands and/or have the listed capabilities.

• 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 (20 inches or less).

Travel

• Occasional travel may be required, typically up to 10-25%, depending on business needs.

In the event that COVID-19 vaccine mandates issued by the federal government, or by state or local government become effective and enforceable, the Company will require that the successful candidate hired for positions covered under relevant government vaccine mandate(s) be fully vaccinated against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.

Applicants to positions where vendor credentialing or other similar requirements exist to enter facilities will be required to comply with the credentialing requirements of the facilities, including complying with vaccine requirements.

For all positions, the Company encourages vaccination against COVID-19 and requires that the successful candidate hired be willing to test for the COVID-19 virus periodically and wear a face covering indoors as required, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail] or [phone]).