Technical WriterBasic Function
Under supervision writes and develops product instructions for use (IFUs) that provide instructions and general information detailing user/patient safety, product features, set up instructions, procedures for handling, maintenance, troubleshooting and specifications. Provides expertise in all aspects of instructional design. Participates in development and maintenance of product labels. Contributes to process improvement within functional area. Receives assignments from supervisor and/or project managers.
Responsibilities
-Develops user instructions for a variety of complex medical devices with input from design engineering, quality assurance engineering, marketing, regulatory affairs, biological sciences, and other subject matter experts to ensure accuracy of information and compliance with FDA, MDD and if appropriate, other standards.
-Interviews subject matter experts, reads journals, reports, and researches various resources to become familiar with product technologies and user methods.
-Organizes content and completes writing assignments according to established guidelines for content, clarity, conciseness, style and terminology.
-Reviews and supports aspects of instructions prepared by others including instructions acquired through product acquisitions.
-Reviews and revises legacy materials and provides inputs for updates, presentation, and methods of production.
-Fluent with word processing and desktop publishing software and has knowledge of print/electronic publishing processes.
-Utilizes Change Management procedures to modify instructional documentation.
-Will assist others within functional area by proofreading, checking and consulting solutions.
-Conceptualizes and may procure photos, illustrations, sketches, diagrams, and tables to provide graphical elements that support instructional information.
-May evaluate and coordinate with service suppliers for functionally related products and/or services.
-Helps establish standardized text, glossaries and nomenclature, style guides and templates, structure and modularization of product information.
-Participates in the research and implementation of technologies such as labeling technologies and XML publishing
-Submits periodic reports on assigned projects to supervisor and or project managers.
Qualifications/Work Experience
-Develops user instructions for a variety of complex medical devices with input from design engineering, quality assurance engineering, marketing, regulatory affairs, biological sciences, and other subject matter experts to ensure accuracy of information and compliance with FDA, MDD and if appropriate, other standards.
-Interviews subject matter experts, reads journals, reports, and researches various resources to become familiar with product technologies and user methods.
-Organizes content and completes writing assignments according to established guidelines for content, clarity, conciseness, style and terminology.
-Reviews and supports aspects of instructions prepared by others including instructions acquired through product acquisitions.
-Reviews and revises legacy materials and provides inputs for updates, presentation, and methods of production.
-Fluent with word processing and desktop publishing software and has knowledge of print/electronic publishing processes.
-Utilizes Change Management procedures to modify instructional documentation.
-Will assist others within functional area by proofreading, checking and consulting solutions.
-Conceptualizes and may procure photos, illustrations, sketches, diagrams, and tables to provide graphical elements that support instructional information.
-May evaluate and coordinate with service suppliers for functionally related products and/or services.
-Helps establish standardized text, glossaries and nomenclature, style guides and templates, structure and modularization of product information.
-Participates in the research and implementation of technologies such as labeling technologies and XML publishing
-Submits periodic reports on assigned projects to supervisor and or project managers.
Education and/or Special Training
B.S. in Technical Writing, English, Instructional Design, or related curriculum.
Percent Travel Required
0-5%
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