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:
- Bachelors degree required (English Technical Writing Technical Communication Communication or related curriculum preferred.
- 2 years applicable Technical Writing experience
Travel Percentage: 10%
Required Experience:
Senior IC
Work Flexibility: Hybrid or OnsiteThis 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...
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:
- Bachelors degree required (English Technical Writing Technical Communication Communication or related curriculum preferred.
- 2 years applicable Technical Writing experience
Travel Percentage: 10%
Required Experience:
Senior IC
View more
View less