Job Summary:
The Technical Writer is responsible for authoring and releasing product documentation and user materials for medical devices.
Duties & Responsibilities:
· Collaborate on and support the development of Directions for Use, Operatorâ s Manuals, and other related product documentation.
· Collaborate with writers, product managers, engineers, 3rd-party suppliers, and other subject matter experts as necessary.
· Ensure documentation meets editorial guidelines and quality standards.
· Organize and schedule multiple documentation reviews with Marketing, Engineering, Quality Assurance, and Regulatory Affairs departments.
· Route documents in document control system, including associated quality system documentation.
· Vet product specifications against documentation to ensure accuracy.
· Coordinate localization/translations for product documentation.
· Manage workload and projects based on priority.
· Perform general desktop publishing as needed.
· Perform other duties or special projects as requested.
Minimum & Preferred Qualifications and Experience:
Minimum Qualifications:
· Minimum of 3 + years of experience as a technical writer creating user facing materials in an industry such as medical devices, consumer electronics, computer hardware/software or other highly regulated industry.
· Experience writing to editorial guidelines.
· Advanced skills in desktop publishing programs such as Adobe InDesign.
· Advanced skills in Microsoft Office Suite, particularly Word, Excel and Teams.
· Excellent organizational, communication, and decision-making skills.
· Ability to work well within a team environment and independently.
· Ability to professionally interact with writers, product managers, engineers, 3rd-party suppliers, and other subject matter experts.
· Ability to balance multiple concurrent projects.
Preferred Qualifications:
· Prior experience in Project Management.
· Prior experience working with Product Marketing and Engineering teams.
· Prior experience with translation and localization of user facing materials.
· Familiarity with FDA and international medical device regulatory processes.
· Proficient in desktop publishing programs such as Adobe InDesign.
· Proficient in document control systems, such as Microsoft SharePoint and Oracle Agile PLM.
· Proficient in component-based/XML-based content management systems (CMS); experience with AuthorIt content management system is a plus.
· HTML and XML experience.
Education:
Bachelorâ s degree in English, Communication, Sciences, related degree, or equivalent experience as a technical writer.