Engineering- Sr. Technical Writer (12 month contract // Minneapolis, MN):
Top 3 Skills:
- Experience authoring IFUs, manuals and user guides
- Experience with marketing and medical literature writing is preferred
- Candidate will need to have strong communication and capability to function highly independently with limited guidance
Description:
As a Senior Technical Writer, you will support the development of customer-facing product labeling for an ablation product line. The labeling may include: instructions for use (IFU), manuals, user guides, device labels, and package labels. You may also work on marketing materials and medical literature. In addition to the labeling itself, you will be accountable for labeling supporting documentation, which may include design plans, requirements documents, review reports, and verification reports. You will directly support R&D projects for both new product development and released product maintenance. We are seeking a highly independent, self-driven, and accountable technical writer with prior experience with medical device labeling and the regulatory process, who requires minimal supervision.
Key responsibilities include the following:
- 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.
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