- Title: Technical Writer
- Code: RCI-ABT-77408
- Location: Santa Clara California (CA) 95054
- Posted Date: 05/15/2019
- Duration: 10 Months
- Status: Open
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 232
Must have a minimum of six years of experience in the medical devices industry as a technical writer
Must be familiar with FrameMaker, Adobe Acrobat, and InDesign
Sr. Technical Writer responsible for developing, writing, editing, and managing Instructions for Use (IFUs), Patient Handbooks (PHBs), Alarm Guides, and Pocket Guides for the Mechanical Circulatory Support (MCS) line of products.
- Position is to create end-user documentation and user manuals for submission to various regulatory bodies, to prepare documentation and user manuals for hand-off to localization and to prepare the manual for release in our document control system.
- Research, write and edit User Manuals to support new and sustaining projects
- Collaborate with project teams to gather information for User Manuals
- Work with Technical Publications peers to follow internal processes and procedures
- Understand and comply with medical device regulatory requirements related to labeling (User Manuals)
- Technical aptitude for learning new tools and systems
- Must be able to work in a fast paced environment
- Requires a Bachelor’s Degree in a relevant technical discipline such as: English, Communications, Science or equivalent
- Must have experience writing clinician/physician and/or patient manuals
- Must have experience with SAP or other Document Control system
- Experience with Author-It, Vasant, or other Content Management System a plus
- Gather input from Engineering, Marketing, Clinical, and Regulatory, etc., to define specific requirements for IFUs.
- Attend project meetings and meeting with individual experts as necessary.
- Enhance professional appearance and readability of product IFUs, PHBs, Guides by editing them for grammar, consistency, style, and format.
- Coordinate final IFU, PHB, Guide implementation to ensure that all requirements and deadlines are met (including translation, freelance graphic designer, documentation release, and print vendors, etc.).
- Produce IFU, PHB, Guide content by following defined requirements, using the following prescribed software: FrameMaker, InDesign, Adobe Acrobat Pro. (Jira and Confluence experience a plus.)