Technical Writer

Position Summary 

Develop and release product labeling documents (including operating manuals, user guides, service manuals, and various other guides) and supporting documents (which may include design history file documentation) for electro-mechanical serialized medical equipment and network applications/software products.  Must be knowledgeable of effective writing styles and the correct use of English in order to translate technologically complex concepts into easy-to-understand language.

Essential Duties & Responsibilities

• Translates requirements into appropriate content that complies with FDA and other governmental agency regulations.
• Interacts with project team personnel (including Engineering, Medical, Marketing, and Regulatory) to obtain technical information needed to create content. 
• Ensures technical writing outputs adhere to departmental standards and practices.
• Coordinates and obtains necessary approvals for release of documentation.
• Must be able work on several projects concurrently, ensuring timely completion of each.
• May support design history file documentation in the role of author or editor.

Knowledge, Skills & Qualifications

• Ability to write in accordance with current technical writing principles and to follow corporate and departmental processes with limited guidance. 
• Strong writing, editing, and proofreading skills. 
• Advanced knowledge of Adobe FrameMaker 10 or later (required for labeling documents). 
• Advanced knowledge of Microsoft Word.
• Working knowledge of Adobe Acrobat.
• Working knowledge of image editing software is desirable (to make minor adjustments to existing graphics or screen captures).

Education and Experience 

• Must be at least 18 years of age
• Associate Degree or comparable college-level coursework required, preferably in English, Communications, Journalism, or a related field. Bachelor’s Degree or commensurate experience preferred.
• Minimum 5 years of technical writing experience required.
• Experience in FDA-regulated environment preferred.

Physical Requirements and Work Environment 

• This is largely a sedentary role. 
• This job operates in a professional office environment and routinely uses standard office equipment.
• Typically requires travel less than 5% of the time