Technical Writer
MedtronicAbout the role
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Our Cardiovascular Portfolio operating units offer devices and therapies that treat patients with abnormal heart rhythms and heart failure, peripheral, coronary, and aortic arterial diseases, and host of other cardiac and blood flow-related ailments. Together, we will transform the lives of people who suffer from these diseases.At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
This position will be based in Mounds View, MN.
In this exciting role as a Technical Writer, you will produce customer-facing product documentation, including but not limited to user guides and instructions for use (IFUs). This includes labeling for both clinicians and patients that accompany medical device products that conform to the Medtronic documentation and quality assurance standards. Projects include R&D new product development as well as sustaining activities/legacy document maintenance for various products produced by the Cardiovascular portfolio. You will identify document requirements, collect inputs from cross-functional technical staff and distill this technical information into detailed, accurate content for manuals and/or web-based documents for technical and non-technical users.
Responsible for supporting documentation to the customer-facing content which may include labeling design plans, trace documents, technical reviews, and verification deliverables. You will support product documentation updates to comply with EU MDR, FDA, EN 60601, and other regulatory body requirements by incorporating customer inputs and ensuring standardization of document development to comply with Medtronic design standards.
Role and Responsibilities
Responsibilities may include the following and other duties may be assigned.
- Plan, research, develop, and write medical device labeling, and manage labeling deliverables as part of cross-functional project teams under general supervision.
- Write clear, simple content that speaks to customers in their own language. Understand the impact of localization on English content and writing for a global audience.
- Effectively communicate the appropriate level of detail based on technical and customer requirements.
- Collaborate openly and effectively with a range of stakeholders, including writers and subject matter experts.
- Understand how regulations, laws, and standards influence content design.
- Understand and adhere to all quality management system documents and product commercialization procedures applicable to labeling development.
- Manage multiple projects and communicate status proactively. Successfully negotiate project schedules, plans, and milestones.
- Contribute to time and cost estimates for labeling deliverables for project teams.
- Take direction to be able to work independently and make sound decisions. Express ideas clearly and diplomatically.
- Develop documentation for regulatory submissions and maintain design documentation to support quality and regulatory process requirements.
- Assist in providing documentation for CAPAs, and departmental and business-unit audits.
- Participate in department and business-unit initiatives.
- Oversee change order process for labeling.
- Coordinate translations and track the status of translations.
- Additional tasks as assigned.
Must Have (Minimum Requirements):
To be considered for this role, the minimum requirements must be evident on your resume.
- Bachelor's degree
- Minimum of 2 years of communications, labeling, and/or technical writing experience
- Advanced degree with 0 years of communications, labeling, and/or technical writing experience
Nice to Have (Preferred Qualifications):
- 2+ years of experience as a technical/medical writer in the medical device, scientific,
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