Engineering - Technical Writer

Can you please confirm your top 3 skills sets required? Technical writingCollaborationCompliance with quality management system procedures Can you please confirm the 3 main responsibilities/day to day activities required for this role? Development of labeling products and associated documentation including prototyping, editing, formatting, and coordinating reviews and approvalsCollaboration with colleagues and cross-functional partners to ensure accuracy and quality of labeling contentManagement of multiple projects and priorities while meeting expected timelines What products (if any) will this role support? This role will support labeling products (user guides, implant manuals, instructions for use) associated with medical devices across the Neuromodulation and Pelvic Health portfolios. What is your target years of experience? 1-8 years of experience __________________________________________________________________________________________________________________ As a Technical Writer, you will support the production of customer facing product documentation, including but not limited to: user guides, service manuals, and instructions for use (IFUs). This includes both clinician and patient labeling that accompanies medical device products within the Neuroscience portfolio. You may work on R&D projects such as new product development and released products maintenance (e.g., sustaining activities and legacy document updates), as well as quality- and compliance- driven projects to ensure our labeling conforms to quality assurance standards and labeling requirements from external standards and regulations (e.g., FDA, EU MDR, ISO, etc.). You will be responsible for both the content in the labeling as well as the supporting documentation, which may include design plans, design input requirements and tracing documents, review documentation, and verification reports. You may also be responsible for investigation, documentation, and resolution of labeling-related quality issues. Typical Responsibilities May Include Manage all aspects of document development and assist in production release, including draft reviews and formal labeling approvals, coordination of translations, and initiating change order release.Revise, edit, and format legacy product documentation as required, including but not limited to user’s guides, service manuals, instructions for providers (IFPs), and instructions for use (IFUs).Ensure compliance of labeling with all applicable regulatory/QSR requirements.Create, edit, and format documentation as part of the compliance with requirements from the European Union (EU Medical Device Regulation).Deliver supporting documentation to the labeling product, including labeling design plans, trace documents, technical reviews and verification deliverables.Effectively manage multiple projects, changes in project scope, and shifting priorities to maintain project requirements and ensure deadlines are met.Collaborate with departmental and cross-functional peers to ensure proper resolution to questions and issues during the document development process.Continually review the document development process to ensure quality in labeling output. Nice To Have Experience working in a federally regulated environment (FDA)Experience with the European Union Medical Device Regulation (EUMDR)Familiarity with Quality/CAPA processes and principlesSelf-directed and highly organizedAbility to manage multiple prioritiesExcellent communication skillsAdvanced writing/editing skillsCross-functional collaborative natureProduct Lifecycle Management software experienceMedical terminology experienceFamiliar with the principles of neuromodulation Product development workflow