Technical Writer

Primary Function of Position

Produce accurate, clearly presented, consistent instructions for use (IFU) for medical device robotic systems and instruments; receive general instructions on day-to-day work and general instructions on new assignments; can be mentored by a more experienced writer; use professional concepts and skills; apply company policies and procedures to resolve a variety of issues.

Essential Job Duties

• Plan, write, and edit instructions for use (IFU) for medical device systems and instruments, including large system manuals, instrument manuals, and ship-with literature using Adobe FrameMaker, Adobe InDesign, or extensible markup language (XML)

• Collaborate with department team members and with cross-functional team Subject Matter Experts (SMEs) to research and develop content for instructions for use and validate content.

• Own document creation from inception to completion

• Work to ensure compliance with FDA and regulatory guidelines.

• Work with interaction designers and technical illustrators to develop documentation images, including raster and vector images.

• Conduct validation and verification of technical documentation

• Understand documentation control steps to release final documentation.

• May participate in product development core teams as representative for technical publications.

• Serve as lead writer on projects and mentor other writers.

• Keep abreast of the basic requirements for compliance in own area of work and complies with those requirements. Participate as required in training on regulatory issues affecting own area of work and share learned expertise with others. Bring regulatory compliance questions/issues to the attention of management.

• Adhere to policies, procedures, and quality documents. Collaborate with project team members to share knowledge and best practices.