Senior Technical Writer

Work Flexibility: Hybrid or Onsite

This is a permanent role with full Stryker benefits.

What you will do:

Supports product teams by independently developing product instructional materials for complex medical devices or product lines. Deliverables may include - product instructions for use, Quick Guides, online help, and other product-related customer facing documentation and analysis of usability of these deliverables. Audience includes physicians, healthcare staff, facility engineers, and patients for a global audience. Deliverables must comply with medical device regulations, standards, and business requirements

KEY AREAS OF RESPONSIBILITY

• Develop customer facing product instructional information for an entire business unit according to user needs and regulatory requirements for domestic and international customers.
• Interface cross-functionally within the product development team to acquire source materials and to develop understanding of the products.
• Interview and collect information from Subject Matter Experts (SMEs) from R&D, RA, various functional areas.
• Write and edit Instructions For Use (IFUs), Quick Start Guides and other accompanying documents aligning content with associated product labels.
• Participate in new product development meetings with cross functional team members to capture inputs, project deliverables and product specifications. 
• Effectively plan and track workload and projects understanding the critical path and interdependencies in a multi-project environment while effectively communicating timelines with project teams.
• Manage multiple assignments for complex projects to meet project milestones.
• Collaborate with the Graphic Designer to incorporate graphical elements for instructional purposes and accurate interpretation and international application.
• Drive and assist with departmental continuous improvement endeavors.
• Review and edit on the work of others prepared work within functional area.
• Trains members of our functional team.
• Provide reviews of regulatory documentation to ensure that medical device labeling references are complete and correct and compliant with FDA and EU requirements.
• Manage IFUs PLM/CMS system for controlled releases and revision management.
• Complete applicable QMS documentation as required by the regulatory and change management process.
• May own NCs/CAPAs as needed.
• May assist with regulatory audits.
• Participate and own improvement projects on the team.

What you will need:

• Bachelor's degree required (English, Technical Writing, Technical Communication, Communication, or related curriculum preferred.
• 2+ years applicable Technical Writing experience

Travel Percentage: 10%