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.
Required Skills and Experience 5 to 8 years technical writing experience in a hardware, software, biotechnology, or medical environment, including documentation for a highly technical audience. Strong experience with current versions of standard authoring tools, including Adobe FrameMaker or Adobe InDesign and Adobe Acrobat, preferred. Working knowledge of Adobe Illustrator, Adobe Photoshop, or equivalent desirable Excellent communication skills required. Strong writing and grammar skills in areas of content development and writing style. Analytical ability to swiftly grasp and effectively communicate complex scientific and engineering concepts. Organizational skills and ability to manage deliverables under tight deadlines, set priorities, and manage time effectively. Familiarity with XML, Darwin Information Typing Architecture (DITA), and content management systems strongly preferred. Software skills that include troubleshooting moderate FrameMaker and InDesign issues; updating or improving an existing document template; troubleshooting online help software errors with minimal assistance; creating error-free PDF files. Verbal communication skills that include responding calmly under pressure and leading content review meetings that result in document approval. Required Education and Training Bachelor’s degree in technical writing, communications, professional writing, English, or equivalent experience preferred. Certificate in technical writing desirable. Preferred Skills and Experience Understanding of mechanical concepts and complex mechanical devices preferred Understanding of localization process preferred
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. Mandatory Notices U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s