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Engineering - Technical Writer - Exempt
Job Description
Join our team in Minneapolis, MN, where you'll be part of a dynamic environment that supports the creation of innovative medical device solutions. As a Technical Writer, you'll be integral to developing high-quality documentation that supports our Neuromodulation and Pelvic Health portfolios.
Must Have
- Quality/Compliance Mindset
- Technical Writing/Documentation
- 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
- Develop labeling products and associated documentation including prototyping, editing, formatting, and coordinating reviews and approvals.
- Collaborate with colleagues and cross-functional partners to ensure accuracy and quality of labeling content.
- Manage multiple projects and priorities while meeting expected timelines.
- 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.
Requires a University Degree and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience. The ideal candidate will have a practical knowledge and demonstrated competence within the job area.
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