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%