View all jobs
Senior Technical Writer
Sunnyvale, CAAmick Brown is seeking an experienced Senior Technical Writer (contingent) for our direct client.
Location: Sunnyvale, CA
Duration: 10 Months
Estimated pay range: $48 - $60 an hour per client contract and candidate skills, experience and work location
Description
Roles & Responsibilities
Required Skills
Regular full-time employees are eligible for the following Amick Brown provided benefits:
Location: Sunnyvale, CA
Duration: 10 Months
Estimated pay range: $48 - $60 an hour per client contract and candidate skills, experience and work location
Description
- 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
- 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.
Required Skills
- 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
Regular full-time employees are eligible for the following Amick Brown provided benefits:
- Vision
- Dental
- 401k Health
- with company match
- Paid time off
- Sick Leave
- long-Term Disability
- Life Insurance
- Wellness & Discount Programs