Technical Communication Specialist & Labeling Designer - Medical Devices (On Site)
About The Position
Medtronic is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life. This role is within the Neurovascular operating unit, which focuses on advancing the treatment of stroke, brain aneurysms, and vascular disorders through innovative endovascular technologies. The Technical Communication Specialist & Labeling Designer will be responsible for developing, maintaining, and releasing labeling and technical documentation for Neurovascular products. This includes preprinted labeling, Instructions for Use (IFU), user guides, system manuals, quick reference guides, package inserts, label stocks, and other related technical literature. The role involves collaborating with product development and cross-functional partners to define labeling strategy, gather requirements, communicate complex information clearly, create plans for document release, and coordinate translation projects. Medtronic emphasizes in-person collaboration, with a requirement of working a minimum of 4 days a week onsite to foster professional growth and cross-functional teamwork.
Requirements
- Requires a Baccalaureate degree.
- Minimum of 2 years of regulatory/product compliance, labeling, technical writing, or technical editing experience in the medical devices industry.
- Possess unrestricted U.S. work authorization at the time of hire and for the duration of employment (for roles below Principal level).
- 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.
Nice To Haves
- Advanced experience with Structured Authoring using XML and content management solutions (CMS).
- Advanced Experience with Adobe Acrobat® and PhotoShop® software, vector graphics software (e.g. Adobe Illustrator®) and HTML.
- Experience writing for a global audience.
- Experience with CMS.
Responsibilities
- Developing, maintaining, and releasing labeling and technical documentation for Neurovascular products, including preprinted labeling, Instructions for Use, user guides, system manuals, quick reference guides, package inserts, label stocks, and other related technical literature.
- Collaborating with product development and cross-functional partners to define labeling strategy, gather labeling requirements, and communicate complex information clearly.
- Creating plans to support document release activities from start to end.
- Identifying IFU/labeling requirements and obtaining necessary content information from various sources.
- Learning and understanding the design and behavior of the company’s products.
- Designing, developing, and maintaining IFU/labeling using Adobe InDesign and other software applications.
- Controlling IFU/labeling versioning and maintaining IFU archives.
- Identifying IFU/labeling translation requirements, preparing, and managing translation projects to completion.
- Managing change control and performing administrative documentation tasks required to establish and track IFU/labeling in a Product Lifecycle Management system.
- Understanding and applying relevant US and EU regulations, standards, and guidance documents (e.g., 21 CFR, EU MDR, IMDRF, ISO20417, ISO15223, and ISO 10555), as well as Medical Device Quality Systems (e.g., ISO 13485) and Risk tools (e.g., ISO 14971).
- Continuously evaluating business processes, identifying improvement opportunities, and implementing improvements.
- Performing quality checks and proofreading artworks.
- Completing projects independently, managing own priorities, and applying company procedures to resolve issues.
- Identifying and pursuing improvement projects.
- Potentially managing the user documentation pool for a specific business segment or segments.
- Managing within a matrixed environment where direction and prioritization may be established via an indirect reporting relationship.
- Performing duties in compliance with the Quality System.
- Performing duties in compliance with environmental, health, and safety-related site rules and policies.
Benefits
- Competitive Salary
- Flexible Benefits Package
- 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
- 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
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
