Senior Technical Writer

East Bay, CA | Contract

Post Date: 11/01/2017 Job ID: 6018 Industry: Software/Hardware
  • Lead the creation of customer-facing user manuals and other instructional content that helps the various users understand and use a highly complex medical device.
  • Produce high-quality documentation that meets applicable regulatory standards and is appropriate for its intended audience.
  • Support user testing of content and identify opportunities for improvement. For example, partner with human factors engineering to conduct usability testing, support the analysis of findings, and recommend/implement appropriate changes to the content.
  • Collaborate with subject matter experts to develop and refine the overall labeling strategy.
  • Develop and communicate accurate time estimates for work load and adhere to schedule of deliverables.
  • Set up a suitable content management system.
  • Develop company standards regarding structure, clarity, consistency, style, and terminology.
  • Maintain organized records and files of work, and standardize content across platforms and media.

 Must haves we’re looking for:

  • 7+ years proven experience in writing, designing, and delivering quality, user-facing technical content on time.
  • 2+ years experience in medical technical communication.
  • A proactive self-starter with an established track record of creating engaging content from start to finish.
  • Demonstrated superior writing skills and meticulous attention to detail.
  • Demonstrated experience with electronic publication formats.
  • Experience working successfully with cross-functional teams.
  • Flexible and adaptable in a fast-paced, start-up environment, and willing to take on additional duties.
  • Proven strong problem solving skills, and ability to creatively solve challenges.
  • Results-driven and goal-oriented – all with a positive attitude.

 We’d prefer if you also have:

  • Interest in and knowledge of radiology or radiation therapy.
  • Experience with and working knowledge of various standards and regulatory guidance documents, such as:
    • AAMI HE-75 – Section 11:2009
    • FDA’s “Write It Right”:1997
    • FDA’s “Applying Human Factors and Usability Engineering to Medical Devices” 2016
    • 21 CFR parts 820

 

 Educational Requirements:

  • Bachelor’s degree in Technical Communication, English, Education, Design, Journalism, Advertising, Public Relations, Marketing, Media Arts or related field is required.
  • Master's preferred.
  • Equivalent combination of experience and education.

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