Amick Brown is seeking an experienced Senior Technical Writer
for our direct client.
Location: Sunnyvale, CA 94086.
Duration: 8 Months with possible extension.
Primary Function of Position:
The Senior Technical Writer ensures that development and delivery of technical documentation is consistent and compliant with regulatory and company guidelines. The Senior Technical Writer produces usable, accurate, clearly presented, consistent instructions for use (IFU). The Senior Technical Writer requires general guidance on new assignments and processes but is expected to complete day-to-day work with little instruction.
Roles & Responsibilities:
Skills, Experience, Education, & Training:
- Plan, write, and edit instructions for use for medical device systems and instruments (system and hardware), and other ship-with literature using Adobe FrameMaker, Adobe InDesign, and 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.
- Own document creation from inception to completion.
- 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 instructions for use.
- Complete documentation control steps to release final documentation. This includes Change Orders in the documentation change control system.
- Participate in product development core teams as representative for technical publications.
- Resolve complex issues in creative and effective ways, using skills as an experienced technical communication professional with understanding of industry best practices and company objectives.
- Act as the lead writer on projects and mentor other writers.
- 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, style guides, and quality documents. Collaborate with project team members to share knowledge and best practices.
- 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 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 skill level using current versions of standard authoring tools, including Adobe FrameMaker and Adobe InDesign.
- Intermediate to expert skill level writing documents in an XML editor (e.g. Arbortext Editor).
- Ability to use prior XML and Darwin Information Typing Architecture (DITA) experience to learn Arbortext Editor and perform assignments with minimal instruction and supervision.
- Experience using content management system (CMS) database (e.g. Windchill), and thorough understanding of document-check in and check-out process.
- 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
Amick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing. The company was founded in 2010 and is headquartered in San Ramon, California.
Regular full-time employees are eligible for the following Amick Brown provided benefits:
- 401k with company match
- Paid time off
- Sick Leave
- Short-Term Disability
- Life Insurance
- Wellness & Discount Programs