At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
Medtronic pioneered the field of neuromodulation with groundbreaking innovations, including the first commercially available spinal cord stimulator for chronic pain, the first deep brain stimulation (DBS) system for movement disorders, and the first implantable drug pump for targeted medication delivery to the intrathecal space of the spine. More than 40 years later, we continue to push the boundaries of innovation, constantly challenging ourselves to disrupt the markets we created. By advancing science with bold thinking and collaboration, we bring together the right expertise to engineer groundbreaking therapies and technologies that transform patient care.
Join a diverse team of innovators who bring their worldview, their unique backgrounds and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
#Neuroscience
Careers That Change Lives
This role of Labeling Specification Specialist requires the management and execution of tasks and deliverables specific to medical device labeling products for various projects within the Medtronic Neuroscience portfolio. Primary responsibilities include the production of customer-facing product documentation, including but not limited to user guides, service manuals, and instructions for use (IFUs) which encompass both clinician and patient labeling accompanying our Neuroscience medical device products. This role will directly support R&D projects such as new product development and released products maintenance (e.g., sustaining activities and legacy document updates), as well as quality- and compliance- driven projects to ensure our labeling conforms to quality assurance standards and labeling requirements from external standards and regulations (e.g., FDA, EU MDR, ISO, etc.). Additionally, this role will include accountability for both the content in the labeling as well as the supporting documentation, which may include design plans, design input requirements and tracing documents, review documentation, and verification reports. Responsibilities may also include supporting the investigation, documentation, and resolution of labeling-related quality issues.
Responsibilities may include the following and other duties may be assigned:
Supports the Neuroscience labeling team in developing and executing on project timelines for programs that impact or include the creation of, or update to, labeling content.
Collaborates with departmental and cross-functional peers to ensure proper resolution to labeling-related and issues during the development process.
Creates and reviews text required for labeling medical products.
Ensures compliance of labeling with all applicable regulatory/QSR requirements.
Monitors, evaluates and recommends improvements to labeling processes, quality, systems tools and/or policies.
Continually reviews the document development process to ensure quality in labeling output.
Manage all aspects of document development and assist in production release, including draft reviews and formal labeling approvals, coordination of translations, and initiating CO/CA release.
Revise, edit, and format legacy product documentation as required, including but not limited to user’s guides, service manuals, instructions for providers (IFPs), and instructions for use (IFUs).
Deliver supporting documentation for the labeling product, including labeling design plans, trace documents, technical reviews and verification deliverables.
Effectively manage multiple projects, changes in project scope, and shifting priorities to maintain project requirements and ensure deadlines are met.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Requires a Baccalaureate degree in a technically related field
minimum of 2 years of relevant experience,
or advanced degree
Nice to Have (Preferred Qualifications)
Self-directed and highly organized; meticulous in nature
Cross-functional collaborative nature: strong collaboration and communication skills to work with diverse teams
Product Lifecycle Management software experience
Content Management software experience
Working in a federally regulated environment (FDA)
European Union Medical Device Regulation (EUMDR)
Medical device labeling-related experience
Familiar with the principles of neuromodulation
Familiar with product development workflow
Ability to manage multiple priorities
Familiarity with Quality/CAPA processes and principals
Excellent communication skills
Advanced writing/editing skills
Medical terminology experience
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.
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.
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
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here.
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.