Engineering - Sr Technical Writer - Exempt

Join our dynamic team in Minneapolis, MN, where you can leverage your skills as a Senior Technical Writer to make a significant impact on our ablation product line. This role offers an exciting opportunity to work on a variety of labeling materials, including instructions for use, manuals, user guides, device labels, and package labels, as well as marketing materials and medical literature.

Must Have:

• Project Management
• Self-driven, independent, and accountable
• Strong Communication Skills
• Technical Writing

Nice to Have:

• Graphic Design
• Graphic Illustrations
• Medical Writing
• Package Labeling

Key Responsibilities:

• Set the strategy and develop plans for projects impacting the labeling for this product line.
• Collaborate with departmental and cross-functional stakeholders and subject matter experts to develop the labeling content and resolve issues as they arise during the development process.
• Ensure compliance of labeling with all applicable regulatory (e.g., FDA, EU MDR, ISO standards, etc.) and quality requirements.
• Write and produce documentation that conforms to quality management system requirements.
• Produce and/or edit graphics, illustrations, and charts that are included within the labeling materials.
• Communicate project status and risks to program, functional, and business leaders.
• Provide input to project schedule development.
• Effectively manage multiple projects, changes in project scope, and shifting priorities to maintain project requirements and ensure deadlines are met.

Required Knowledge and Experience:

• Advanced knowledge of the job area (breadth and depth), typically through advanced education plus experience.
• May have practical project management knowledge.

Education/experience requirement: Baccalaureate degree (or qualifying foreign equivalent under 8 C.F.R. § 214.2(h)(4)(iii)(A)) and a minimum of 4 years relevant experience, or an advanced degree with a minimum of 2 years relevant experience.