Medtronic Plc
Senior Technical Writer
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. 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. This position will be based in Mounds View, MN. 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 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 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 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): Bachelor's 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 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. Salary ranges for U.S (excl. PR) locations (USD): $83,200.00 - $124,800.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). 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 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.
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. 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. This position will be based in Mounds View, MN. 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 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 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 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): Bachelor's 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 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. Salary ranges for U.S (excl. PR) locations (USD): $83,200.00 - $124,800.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). 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 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.