Job description

Join our team in Minneapolis, MN, a vibrant city known for its rich cultural scene and thriving business environment. As a Technical Writer, you'll play a crucial role in supporting the production of customer-facing product documentation, including user guides, service manuals, and instructions for use (IFUs) for medical device products. Must Have Skills • Quality/Compliance Mindset • Technical Writing/Documentation Nice to Have Skills • Adobe Indesign • Content Management System • Experience working in a federally regulated environment (FDA) • Experience with the European Union Medical Device Regulation (EUMDR) • Familiarity with Quality/CAPA processes and principles • Self-directed and highly organized • Ability to manage multiple priorities • Excellent communication skills • Advanced writing/editing skills • Cross-functional collaborative nature • Product Lifecycle Management software experience • Medical terminology experience • Familiar with the principles of neuromodulation • Product development workflow Main Responsibilities • Development of labeling products and associated documentation, including prototyping, editing, formatting, and coordinating reviews and approvals. • Collaboration with colleagues and cross-functional partners to ensure accuracy and quality of labeling content. • Management of multiple projects and priorities while meeting expected timelines. Typical Responsibilities • 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 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 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. Target Experience 1-8 years of experience Work Environment Primarily onsite (4 days minimum), with the option to work remotely 1 day per week.

Requirements

Must-haves

Must Have Skills
Quality/Compliance Mindset
Technical Writing/Documentation
Adobe Indesign
Content Management System
Experience working in a federally regulated environment (FDA)
Experience with the European Union Medical Device Regulation (EUMDR)
Familiarity with Quality/CAPA processes and principles
Self-directed and highly organized
Ability to manage multiple priorities
Excellent communication skills
Advanced writing/editing skills
Cross-functional collaborative nature
Product Lifecycle Management software experience
Medical terminology experience
Familiar with the principles of neuromodulation
Product development workflow
Development of labeling products and associated documentation, including prototyping, editing, formatting, and coordinating reviews and approvals.
Collaboration with colleagues and cross-functional partners to ensure accuracy and quality of labeling content.
Management of multiple projects and priorities while meeting expected timelines.
Typical Responsibilities
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 user’s guides, service manuals, instructions for providers (IFPs), and instructions for use (IFUs).

Nice-to-haves

Nice to Have Skills

Application prep

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Effort: medium