Technical Writer - CRM
Job Description
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.
A Day in the Life
Our Cardiovascular Portfolio operating units offer devices and therapies that treat patients with abnormal heart rhythms and heart failure, peripheral, coronary, and aortic arterial diseases, and host of other cardiac and blood flow-related ailments. Together, we will transform the lives of people who suffer from these diseases.At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re 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.
In this exciting role as a Technical Writer, you will produce customer-facing product documentation, including but not limited to user guides and instructions for use (IFUs). This includes labeling for both clinicians and patients that accompany medical device products that conform to the Medtronic documentation and quality assurance standards. Projects include R&D new product development as well as sustaining activities/legacy document maintenance for various products produced by the Cardiovascular portfolio. You will identify document requirements, collect inputs from cross-functional technical staff and distill this technical information into detailed, accurate content for manuals and/or web-based documents for technical and non-technical users.
Responsible for supporting documentation to the customer-facing content which may include labeling design plans, trace documents, technical reviews, and verification deliverables. You will support product documentation updates to comply with EU MDR, FDA, EN 60601, and other regulatory body requirements by incorporating customer inputs and ensuring standardization of document development to comply with Medtronic design standards.
Role and Responsibilities
Responsibilities may include the following and other duties may be assigned.
- Plan, research, develop, and write medical device labeling, and manage labeling deliverables as part of cross-functional project teams under general supervision.
- Write clear, simple content that speaks to customers in their own language. Understand the impact of localization on English content and writing for a global audience.
- Effectively communicate the appropriate level of detail based on technical and customer requirements.
- Collaborate openly and effectively with a range of stakeholders, including writers and subject matter experts.
- Understand how regulations, laws, and standards influence content design.
- Understand and adhere to all quality management system documents and product commercialization procedures applicable to labeling development.
- Manage multiple projects and communicate status proactively. Successfully negotiate project schedules, plans, and milestones.
- Contribute to time and cost estimates for labeling deliverables for project teams.
- Take direction to be able to work independently and make sound decisions. Express ideas clearly and diplomatically.
- Develop documentation for regulatory submissions and maintain design documentation to support quality and regulatory process requirements.
- Assist in providing documentation for CAPAs, and departmental and business-unit audits.
- Participate in department and business-unit initiatives.
- Oversee change order process for labeling.
- Coordinate translations and track the status of translations.
- Additional tasks as assigned.
Must Have (Minimum Requirements):
To be considered for this role, the minimum requirements must be evident on your resume.
- Bachelor's degree
- Minimum of 2 years of communications, labeling, and/or technical writing experience
- Advanced degree with 0 years of communications, labeling, and/or technical writing experience
Nice to Have (Preferred Qualifications):
- Exceptional writing and communication skills
- Excellent problem-solving skills
- Self-directed and highly organized
- Strong attention to detail and accuracy
- Experience working with cross-functional project teams
- Experience authoring in XML within a content management system
- Experience creating content for software or apps and managing software documentation projects
- Experience using product lifecycle management (PLM) software
- Demonstrated ability to meet deadlines and manage multiple priorities
- Ability to work effectively across disciplines to implement creative solutions to complex problems
- Knowledge of Medtronic products and quality systems
- Knowledge of formal reviews and system validation processes. Knowledge of software technologies used for writing, publishing, and document control
- Knowledge of structured writing and minimalism
- Aptitude to learn new requirements, processes, and tools
- Understand industry trends in technical communication, information
- architecture, and content development
- 2+ years of experience as a technical/medical writer in the medical device, scientific, or other regulated industry
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.
Benefits & Compensation
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
About Medtronic
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.
Company Information
Location: Dublin, Ireland
Type: Hybrid