Technical Writer

Medtronic • Mounds View, MN

2d • Onsite

About The Position

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.

Requirements

• 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 Haves

• 2+ years of experience as a technical/medical writer in the medical device, scientific, or other regulated industry
• Understand industry trends in technical communication, information architecture, and content development
• Experience creating content for software or apps and managing software documentation projects
• Experience using product lifecycle management (PLM) software
• Exceptional writing and communication skills
• Experience working with cross-functional project teams
• Experience authoring in XML within a content management system
• Demonstrated ability to meet deadlines and manage multiple priorities
• Ability to work effectively across disciplines to implement creative solutions to complex problems
• Knowledge of Medtronic products and quality systems
• Knowledge of formal reviews and system validation processes.
• Knowledge of software technologies used for writing, publishing, and document control
• Knowledge of structured writing and minimalism
• Aptitude to learn new requirements, processes, and tools
• Excellent problem-solving skills
• Self-directed and highly organized
• Strong attention to detail and accuracy
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Responsibilities

• 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.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
• Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees