Senior Staff Technical Writer
Posted 2025-08-26
Remote, USA
Part Time
Immediate Start
Stryker is hiring a Senior Staff Technical Writer in Portage, MI to support our Instruments Divisions! In this role, you will support product development 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, along with usability analysis, all of which must comply with medical device regulations, industry standards, and business requirements. Content is developed for a global audience that includes physicians, healthcare staff, facility engineers, and patients.
What you’ll do:
• 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, and 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 across complex projects to meet key milestones, while also contributing to team improvement initiatives.
• Collaborate with the Graphic Designer to incorporate graphical elements for instructional purposes and accurate interpretation and international application.
• Review and edit the work of others prepared 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 and assist with regulatory audits.
What you need:
Required:
• 6+ years of applicable Technical Writing experience.
• Bachelor's degree required (English, Technical Writing, Technical Communication, Communication, or related curriculum preferred)
Preferred:
• Apply fundamental and advanced concepts, practices, and procedures related to IFUs.
• Detail oriented with the ability to manage multiple simultaneous projects while providing collaborative customer service.
• Experience with a rigorous change management process.
• Demonstrated ability to manage multiple priorities and meet deadlines in a fast-paced, regulated environment
• Strong analytical and problem-solving skills applied to technical documentation workflows
• Interest in global communication, with an understanding of how language translation impacts content structure and format design
• Ability to quickly learn and adapt to new tools and technologies relevant to technical communication.
Apply to This Job
What you’ll do:
• 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, and 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 across complex projects to meet key milestones, while also contributing to team improvement initiatives.
• Collaborate with the Graphic Designer to incorporate graphical elements for instructional purposes and accurate interpretation and international application.
• Review and edit the work of others prepared 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 and assist with regulatory audits.
What you need:
Required:
• 6+ years of applicable Technical Writing experience.
• Bachelor's degree required (English, Technical Writing, Technical Communication, Communication, or related curriculum preferred)
Preferred:
• Apply fundamental and advanced concepts, practices, and procedures related to IFUs.
• Detail oriented with the ability to manage multiple simultaneous projects while providing collaborative customer service.
• Experience with a rigorous change management process.
• Demonstrated ability to manage multiple priorities and meet deadlines in a fast-paced, regulated environment
• Strong analytical and problem-solving skills applied to technical documentation workflows
• Interest in global communication, with an understanding of how language translation impacts content structure and format design
• Ability to quickly learn and adapt to new tools and technologies relevant to technical communication.
Apply to This Job