Technical Writer

Engineering- Technical Writer (12-month contract // Minneapolis, MN) (W2 Only!!!)

Manager Note: 4 days onsite / 1 day remote per week

Top 3 Skills Required:

1. Technical writing
2. Collaboration
3. Compliance with quality management system procedures

Primary 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

Education Required: Bachelor’s Degree

Target Years of Experience: 2-7 years of experience

Description:

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 client’s 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.

Duties:

• 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.