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
Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.