Cynet Systems Inc
Job Description:
Pay Range: $58.54hr - $63.54hr
Essential Job:
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, XX, or equivalent experience preferred. Certificate in technical writing desirable. Working Conditions: None Preferred Skills and Experience: Understanding of mechanical concepts and complex mechanical devices preferred Understanding of localization process preferred
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Pay Range: $58.54hr - $63.54hr
Essential Job:
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, XX, or equivalent experience preferred. Certificate in technical writing desirable. Working Conditions: None Preferred Skills and Experience: Understanding of mechanical concepts and complex mechanical devices preferred Understanding of localization process preferred
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