Senior Technical Writer

Stryker is hiring a Senior Technical Writer in Portage, MI to support our Instruments Divisions! In this role, you will support product development teams by 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.
• 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:

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

Preferred:

• Able to 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

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.