At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

In this exciting role as a Senior Technical Writer you will produce labeling requirements from global laws regulations standards and guidance documents to support enterprise wide labeling developers. These labeling developers create 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 productsthat 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 across the country.

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

• Responsibilitiesmay include the following and other duties may be assigned.
• Review global laws regulations standards and guidance documents for labeling requirements
• Distill labeling requirements into verifiable engineering statements tag with metadata and enter into database for use by labeling developers
• Review new or changing laws regulations standards and guidance documents and assess effort and impact to document the labeling requirements within them
• Collaborate with subject matter experts from various disciplines including labeling regulatory quality and engineering functions
• Help to administer database including creating metadata managing requirement objects evaluating software updates etc
• Assist with training development and delivery to system users

Must Have (Minimum Requirements):

To be considered for this role the minimum requirements must be evident on your resume.

• Bachelors degree
• Minimum of 4 years of communications labeling and/or technical writing experience
• Advanced degree with 2 years of communications labeling and/or technical writing experience

Nice to Have (Preferred Qualifications):

• Experience in a regulated industry
• Medical biomedical and/or regulatory background
• A technical background AI experience and experience with relational databases
• Knowledge of Medtronic products and quality systems
• 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
• Ability to work effectively across disciplines to implement creative solutions to complex problems
• 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
• Demonstrated ability to meet deadlines and manage multiple priorities
• Exceptional writing and communication skills
• Excellent problem-solving skills
• Self-directed and highly organized
• Strong attention to detail and accuracy

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 insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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 95000 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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.