COV - Covidien PL (Vietnam R.O.)
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On-site · Irvine, California, United States$85k–127kFull-timeUpdated 2 weeks ago
COV - Covidien PL (Vietnam R.O.)
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Careers that change lives start here. 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.
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. The 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.
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.
If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com.
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The following benefits and additional compensation are available to those regular employees who work 20+ 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/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: 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).
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. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
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.
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
