Engineering - Technical Writer

Please confirm your top 3 skills sets required?

• Strong collaboration, verbal/written communication skills, and technical writing core competencies.
• Experience with various authoring tools (eg, InDesign, Framemaker, XML tools).
• Experience in complex regulatory environments and robust quality processes.
  
  

Can you please confirm the 3 main responsibilities/day to day activities required for this role?

• Update Instructions for Use to align with cross-functional feedback, standards compliance, and other inputs in alignment with Tech Comm and business quality processes.
• Support approvals in PLM tools, facilitate translations requests, and support launch activities (electronic and hardcopy distribution activities, such as metadata information and print proofs).
• Participate in project and team meetings and collaborate with teams to create, analyze, and finalize Instructions for Use from planning through launch.
  
  

What is your target years of experience? 5-10 years

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Responsibilities may include the following and other duties may be assigned.

• Plan, research, develop, and write medical device labeling, and manage labeling deliverables as part of cross-functional project teams under general supervision.
• Simultaneously manage up to two labeling updates and one small, new-product-introduction project that involves multiple labeling pieces.
• Understand and adhere to all quality management system documents and product commercialization procedures applicable to labeling development.
• Conducts interviews with various users and technical staff to gather data for documentation.
• Recommends formats responsive to technical and customer requirements.
• Assist in providing documentation for CAPAs, and departmental and business-unit audits.
• Contribute to time and cost estimates for labeling deliverables for project teams.
• Develop illustrations in cooperation with professional illustrators.
• Participate on department and business-unit initiatives.
• Oversee Engineering Change Order process for labeling.
• Coordinate translations and track the status of translations.
• Complete labeling proofs, develop documentation for regulatory submissions, and carry out other tasks as assigned.