Technical Writer - Onsite

Medtronic • Irvine, CA

1d • $68,000 - $102,000 • Onsite

About The Position

Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. Across our global Neuroscience organization, we advance care for some of medicine’s most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey. Our Neurovascular operating unit advances treatment of stroke, brain aneurysms, and vascular disorders through innovative endovascular technologies. With devices designed for revascularization, embolization, and precise intervention, we support clinicians in delivering timely, effective care for complex neurovascular conditions. We are 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.

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.

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

• Responsible for developing, maintaining, and releasing labeling and technical documentation for Neurovascular products, including all preprinted labeling, Instructions for Use, user guides, system manuals, quick reference guides, package inserts, label stocks, and other related technical literature.
• Collaborates with product development and cross-functional partners to define labeling strategy, gather labeling requirements, communicate complex information clearly, create plans to support document release activities, and coordinate translation projects.
• The Tech comm Specialist/ Writer responsible for developing regulatory tech comm and labeling strategy.
• Create plans to support document release activities from start to end.
• Identify IFU/labeling requirements and obtain necessary content information from various sources.
• Learn and understand the design and behavior of the company’s products.
• Design, develop, and maintain IFU/labeling using Adobe InDesign and other software applications.
• Control IFU/labeling versioning and maintain the IFU archives.
• Identify IFU/labeling translation requirements, prepare and manage translation projects to completion.
• Manage change control and perform the administrative documentation tasks required to establish and track IFU/labeling in a Product Lifecycle Management system.
• Understand and apply 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 evaluate business processes, identify improvement opportunities, and implement improvements.
• Perform quality checks and proofread the artworks.
• The Tech comm Specialist/ Writer is expected to complete projects independently, manage their own priorities, apply company procedures to resolve issues, identify and pursue improvement projects, and may be required to manage the user documentation pool for a specific business segment or segments.
• The Tech comm Specialist/ Writer is expected to manage within a matrixed environment, where direction, prioritization of work, and other daily activities may be established via an indirect reporting relationship.
• Occasional domestic and international travel may be required.
• All activities must be performed in compliance with the Quality System.
• Performs duties in compliance with environmental, health, and safety-related site rules and policies.
• All other duties as assigned.

Benefits

• 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 (subject to IRS earning minimums)
• 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: Principal