Technical Writer needed for Medical Device company

RESPONSIBILITY


This position supports Cyberonics’ labeling efforts. This includes development and implementation of labels, inserts, instructions, and patient and physician manuals for Cyberonics products.

PRIMARY ACTIVITIES
• Responsible for designing, developing, writing, and editing labeling text documents per regulatory, marketing, and clinical requirements and generating label specifications, including label stock, printing, adhesives, etc.
• Ensures that product information terminology is consistent, easy to understand, well organized, easily referenced, and follows company standards and regulatory requirements.
• Reviews documentation for completeness and accuracy.
• Coordinates graphics display and document production.
• Maintains labeling database entries.
• Acts as liaison with Regulatory, Marketing, Engineering, and Clinical for label generation.
• Assists Product Managers by developing document plans for product releases.
• Assists and/or coordinates labeling activities with Project Manager on new product development.
• Assists and/or coordinates with the Product Engineer for maintaining labeling information in the DMR.
• Assists and/or coordinates label translation and printing operations with outside vendors.
• Acts as liaison with Manufacturing for label implementation.
• Coordinates with the Document Control department to obtain approval for new labeling proposals and modifications to existing labeling.
• Performs other duties as may be required by supervisor.

ADDITIONAL ACTIVITIES

• Assists Documentation department and technical writers as needed.
• Assists Engineering department in preparing reports to outside agencies.
• Assists Engineering and Regulatory departments in preparing documents for submission to regulatory agencies.
• Provides assistance to eliminate grammatical errors and improve overall document quality and writing style.

Level 2 - Provides general guidance of Level 1 Technical Writers
Level 3 – Provides general oversight and guidance of lower-level Technical Writers

TRAVEL REQUIREMENTS

• This position may require business travel.

MINIMUM REQUIREMENTS AND QUALIFICATIONS

• Excellent written and verbal communication skills
• Strong research and organizational skills
• Familiarity with a variety of the field’s concepts, practices, and procedures
• Experience with project scheduling and/or creating detailed document plans
• Proficient in MS Office tools (Outlook, Project, PowerPoint, Word, and Excel)
• Proficient in Adobe FrameMaker

DESIRED SKILLS AND QUALIFICATIONS

• Bachelor’s degree in technical writing, English, communications, or related technical discipline
• Experience with FrameMaker version 7.0
• Experience with Font Management
• Experience with QuarkXpress
• Experience in pre-press graphics handling
• 3-5 years experience in the implantable medical device field

EDUCATION AND EXPERIENCE

• Level 1 –Bachelor’s degree in technical writing, English, communications, or related technical discipline; or relevant experience
• Level 2 – Bachelor’s degree with five or more years technical writing experience and 1 to 2 years labeling experience; or relevant experience
• Level 3 –Bachelor’s degree with eight or more years writing experience and 3 or more years labeling experience ; or relevant experience