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.
Qualifications :
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
Preferred Skills and Experience
- Understanding of mechanical concepts and complex mechanical devices preferred
- Understanding of localization process preferred
Additional Information :
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
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.
We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target compensation ranges are listed.
Remote Work :
No
Employment Type :
Full-time
Primary Function of PositionProduce 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 prof...
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.
Qualifications :
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
Preferred Skills and Experience
- Understanding of mechanical concepts and complex mechanical devices preferred
- Understanding of localization process preferred
Additional Information :
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
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.
We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target compensation ranges are listed.
Remote Work :
No
Employment Type :
Full-time
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