Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Requisition ID: 201187
The Senior Technical Writer ensures that development and delivery of technical documentation is consistent and compliant with support needs and company guidelines. The Senior Technical Writer produces accurate, clearly presented, consistent customer product documentation on time for product shipment, and requires no instruction on day-to-day work, general instruction in new assignments.
Roles & Responsibilities:
- Plan, write, and edit instructions for use (IFU) for medical device systems and instruments, including large system manuals, instrument manuals, and ship- with literature using Adobe FrameMaker, Adobe InDesign, or extensible markup language (XML)
- Collaborate with department team members and with cross-functional team Subject Matter Experts (SMEs) to research and develop content for instructions for use and validate content
- Own document creation from inception to completion
- Work to ensure compliance with FDA and regulatory guidelines
- Work with interaction designers and technical illustrators to develop documentation images, including raster and vector images
- Conduct validation and verification of technical documentation
- Complete documentation control steps to release final documentation. This includes Change Orders in the documentation control system.
- May participate in product development core teams as representative for technical publications
- Use skills as an experienced technical communication professional with understanding of industry best practices and company objectives to resolve complex issues in creative and effective ways
- Serve as lead writer on projects and mentor other writers
- Determine best means to solve technical problems. Evaluate, recommend, or develop process and productivity aids.
- Keep abreast of the basic requirements for compliance in own area of work and complies with those requirements. Participate as required in training on regulatory issues affecting own area of work and share learned expertise with others. Bring regulatory compliance questions/issues to the attention of management.
- Adhere to policies, procedures, and quality documents. Collaborate with project team members to share knowledge and best practices.
Skills, Experience, Education, & Training:
- 8+ years technical writing experience in a hardware, software, biotechnology, or medical environment, including documentation for a highly technical audience.
- Bachelor’s degree in communications, professional writing, English, biological/medical/engineering sciences, or equivalent preferred
- Strong writing and grammar skills in areas of content development and writing style. Analytical ability to swiftly grasp and effectively communicate complex scientific and engineering concepts.
- Strong organizational skills and ability to manage deliverables for multiple projects under tight deadlines, set priorities, and manage time effectively.
- Understanding of mechanical concepts and complex mechanical devices required.
- Expert knowledge of current versions of standard authoring tools, including Adobe FrameMaker or Adobe InDesign and Adobe Acrobat experience preferred
- XML, Darwin Information Typing Architecture (DITA), and content management experience preferred
- Working knowledge of Adobe Illustrator, Adobe Photoshop, or equivalent desirable
- Previous experience with medical devices and a regulated environment preferred
- Understanding of localization process preferred