Senior Technical Writer

East Bay, CA | Direct Hire

Post Date: 09/29/2017 Job ID: 6009 Industry: Software/Hardware

Company Description:

Each and every day at our company, we have the opportunity to do once-in-a-generation work.
We are aiming to transform cancer treatment and impact the lives of millions of patients around the world.

To achieve this, we will need to build the next great medical equipment company. And this can only happen if we assemble a world-class team of innovative, creative, dedicated and collaborative employees.

We desire people who can move fast in an unconstrained environment but who also possess the foresight and experience to avoid roadblocks.

We want bold, results-oriented individuals with the strength of character and humility to foster a corporate culture built on a foundation of trust.

Our future team mates will unabashedly and relentlessly help us create a new category of cancer care.

Come and join a company on an incredible and meaningful mission.

 Job Description:

Our company is seeking a Senior Technical Writer to lead the creation of user-facing documentation for our revolutionary radiation therapy device. In this position, you will work with engineers, UX designers, clinical experts, and regulatory affairs to architect and create a series of manuals, guides and training materials. As well as the hands-on aspect of this foundational position, we are looking for someone with the experience and vision to choose the tools and mediums that will meet our needs now and in the future.

 Essential Duties and Responsibilities:

  • 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 for RefleXion Medical.
  • 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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