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

Medtronic; Irvine (CA); On-site; USD 85,000 - 127,000; Full time

Benefits offered by this job

Health insurance

401(k) matching

Job summary

Medtronic in Irvine, CA is seeking a Sr. Technical Writer – Labeling Content and Artwork Development to develop, maintain, and manage labeling content for neurovascular medical devices across the product lifecycle.

This onsite role partners with Regulatory Affairs, Quality, R&D, Clinical, and Marketing to ensure accurate, clear, and compliant labeling documentation and artwork content. The role translates complex technical information into user-friendly content and supports labeling changes,

Qualifications

• Bachelor's degree in a relevant field with 4+ years in technical writing or labeling within regulated environments.
• Advanced degree with 2+ years in technical writing or labeling is also acceptable.

Responsibilities

• Develop, write, review, and maintain medical device labeling content including IFUs, labels, and package inserts.
• Collaborate with Regulatory Affairs, Quality, R&D, Clinical, and Marketing to ensure labeling accuracy and compliance.
• Create and manage artwork content for labeling components following design control and document control processes.
• Interview SMEs to obtain technical and product content and translate complex information for healthcare professionals.

Education

Bachelor's degree

Advanced degree

Job description

A Day in the Life

The Neurovascular Operating Unit develops technologies that enable the treatment of acute ischemic stroke, hemorrhagic stroke, and other neurovascular conditions. The team partners across Research and Development, Regulatory Affairs, Quality, Clinical, Manufacturing, and Marketing to deliver products that support physicians and improve patient outcomes. This role is based in Irvine, California and follows an onsite work arrangement. The position supports labeling content and artwork development activities for medical devices throughout the product lifecycle, from new product development through sustaining engineering and change management. No travel is required for this position.

The Sr. Technical Writer - Labeling Content and Artwork Development is responsible for developing, maintaining, and managing labeling content for neurovascular medical devices. This role partners with cross-functional stakeholders to create clear, accurate, and compliant labeling documentation and artwork content that meets regulatory, quality, and business requirements. This position requires translating complex technical information into user-focused content while supporting labeling changes, product launches, and design control activities.

Primary 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 established 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 content 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.

Required Qualifications

• Bachelor's degree and a minimum of 4 years of relevant technical writing, labeling, documentation, or regulated-industry experience; or an advanced degree with a minimum of 2 years of relevant experience.


• Minimum of 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.


• Translating 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.

Preferred Qualifications

• Experience developing labeling content and artwork for medical devices.


• Experience working within the 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.


• 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.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Benefits & Compensation

• 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).

Salary ranges for U.S (excl. PR) locations (USD):$84,800.00 - $127,200.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.

Additional benefits details and notes: Some benefits may not apply to workers in Puerto Rico.

EEO information

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

Additional notes

For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email [e-mail] To request removal of your personal information from our systems please email [e-mail]