Technical Writer
Medtronic
Summary
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 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 regulations and international standards by incorporating customer inputs and ensuring standardization of document development to comply with Medtronic design standards.
Job description
Role and 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.
- Coordinate IFU release in the Product Lifecycle Management system (Windchill, Agile PLM, and Azure DevOps).
- 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.
- Coordinate translations and track the status of translations.
- Additional tasks as assigned.
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
- 2+ years of experience as a technical/medical writer in the medical device, scientific, or other regulated industry
- Experience creating content for software or apps and managing software documentation projects
- Experience using application lifecycle management software (for example, Azure DevOps)
- Understand industry trends in technical communication, information architecture, and content development
- Exceptional writing and communication skills
- Experience working with cross-functional project teams
- Experience authoring in XML within a content management system (for example, Author-it, Paligo, MadCap)
- 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
- 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
Benefits
- Health, Dental & Vision Insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life Insurance
- Long-term Disability Leave
- Dependent Daycare Spending Account
- Tuition Assistance
- 401(k) Matching
- Paid Time Off
- Paid Holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Short-term Disability
- Incentive Plans
Company overview
Medtronic is a global healthcare technology leader and one of the world's largest medical device companies, founded in 1949 in Minneapolis, Minnesota. The company operates in over 150 countries and employs more than 90,000 people worldwide. Medtronic's mission is to alleviate pain, restore health, and extend life through innovative medical technologies. The company develops and manufactures devices and therapies to treat more than 70 health conditions, including cardiac devices, cranial and spine robotics, insulin pumps, surgical tools, patient monitoring systems, and more. With a rich history that began with the invention of the battery-powered pacemaker, Medtronic has grown into a diversified healthcare technology company with four main business units: Minimally Invasive Therapies Group, Diabetes Group, Restorative Therapies Group, and Cardiac and Vascular Group. The company's therapies help approximately 72 million people annually and represent a significant force in advancing medical technology to address some of humanity's most challenging health problems.