Senior Technical Writer - Labeling content and artwork development ( Medical Devices) - On-site

Medtronic • Irvine, CA

5d • $84,800 - $127,200 • Onsite

About The Position

The Senior Technical Writer develops, maintains, and manages labeling content for neurovascular medical devices. The role supports labeling content and artwork development across the product lifecycle, from new product development through sustaining engineering and change management. It translates complex technical, scientific, and clinical information into clear, user-focused content that meets regulatory, quality, and business requirements.

The position partners with Regulatory Affairs, Quality, Research and Development, Clinical, and Marketing stakeholders to create compliant labeling documentation and artwork. It supports labeling changes, product launches, design control activities, regulatory submissions, post-market activities, and continuous improvement initiatives. The role is based onsite in Irvine, California, and requires no travel.

Requirements

• Bachelor's degree and at least 4 years of relevant technical writing, labeling, documentation, or regulated-industry experience; or an advanced degree and at least 2 years of relevant experience.
• At least 2 years of experience developing technical documentation, labeling content, or user-facing documentation within a regulated environment.
• Experience collaborating with cross-functional stakeholders to develop and manage controlled documentation.
• Ability to translate complex technical information into clear written content for technical and nontechnical audiences.
• Experience using document management systems, document control processes, or quality-controlled documentation workflows.
• For baccalaureate degrees earned outside 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

• Experience developing labeling content and artwork for medical devices.
• Experience working within FDA, European Union Medical Device Regulation (EU MDR), or other global medical device regulatory frameworks.
• Knowledge of medical device design control, change management, and product lifecycle processes.
• Experience supporting neurovascular, cardiovascular, or other implantable and interventional medical device products.
• Experience working with artwork management, labeling systems, or electronic quality management systems.

Responsibilities

• Develop, write, review, and maintain medical device labeling content, including Instructions for Use (IFUs), product labels, package inserts, and related documentation.
• Partner with Regulatory Affairs, Quality, Research and Development, Clinical, and Marketing teams to gather information and ensure labeling accuracy and compliance.
• Create and manage artwork content for labeling components in accordance with design control and document control processes.
• Conduct interviews and information-gathering sessions with subject matter experts to obtain technical and product-specific content.
• Translate complex scientific, engineering, and clinical information into clear documentation for healthcare professionals and other intended users.
• Support labeling updates associated with product changes, regulatory submissions, post-market activities, and continuous improvement initiatives.
• Ensure documentation and artwork comply with applicable quality system requirements, regulatory standards, and internal documentation procedures.
• Participate in document reviews, change control activities, and approval workflows to support timely product development and release objectives.

Benefits

• Competitive salary and flexible benefits package.
• Short-term incentive through the Medtronic Incentive Plan (MIP).
• For regular employees working 20 or more hours per week: health, dental, and vision insurance; Health Savings Account; Healthcare Flexible Spending Account; life insurance; long-term disability leave; dependent daycare spending account; tuition assistance or reimbursement; and Simple Steps global well-being program.
• For all regular employees: incentive plans; 401(k) plan with 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: Senior