We anticipate the application window for this opening will close on - 1 Sep 2025  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.<h1>A Day in the Life</h1><div><div>Careers that Change Lives </div><div>Our space, the medical device and healthcare industry, is rapidly changing.  It always has been that way.  Agility and responsiveness are critical to our success with remote monitoring, wearables, robotics, AR/VR, telemedicine, and more.  Experience what it’s like to work at a company with an exciting product pipeline of patented inventions driving innovation in the healthcare space. </div><div>The Ear, Nose, and Throat Operating Unit is a global leader and trusted partner for innovative ENT solutions that improve patient access, outcomes, and customer satisfaction. We partner with the ENT community to understand the needs of customers and patients, delivering solutions that will enhance lives as we embody a culture of accountability and trust. </div><div>Over the past 20 years, we have become the global market leader in three key segments – image-guided surgery, intraoperative nerve monitoring, and powered surgical instruments. We continue to launch valuable ENT solutions in tissue health and balloon sinus dilation. </div><div>Responsibilities may include the following and other duties may be assigned: </div><div><ul><li>Support the development of investigation guidance and technical analysis of product complaints, ensuring timely resolution and consistency in supporting documentation and reportability decisions. </li></ul></div><div><ul><li>Investigate and bound product quality issues for containment and corrective action. </li></ul></div><div><ul><li>Support the development and maintenance of risk management/ complaint analysis procedures to support business efficiency in alignment with applicable regulations.  </li></ul></div><div><ul><li>Lead or support updates to product risk management files based on post-market data in alignment with ISO 14971:2019 and applicable regulations. </li></ul></div><div><ul><li>Perform advanced analysis of quality data (including complaints, CAPA, and post-market surveillance) using tools such as Microsoft Excel, Power BI, VBA, and statistical methods to identify trends, drive root cause investigations, and support data-driven decision making. </li></ul></div><div><ul><li>Support and organize responses to regulatory inquiries about post-market quality data. </li></ul></div><div><ul><li>Prepare and participate in internal and external audits in the areas of risk management and post-market regulatory compliance. </li></ul></div><div><ul><li>Support activities from CAPAs, audits, quality plans, or other regulatory commitments. </li></ul></div><div>Must Have: Minimum Requirements </div><div><ul><li>Bachelor’s degree required in Mechanical Engineering, Electrical Engineering, Computer Engineering, or a technical field. </li></ul></div><div><ul><li>Minimum of 4 years of Quality Engineering experience or advanced degree with a minimum of 2 years relevant experience. </li></ul></div><div>To Be Successful in this role: </div><div><ul><li>Experience in the medical device, in-vitro diagnostics or pharma industries </li></ul></div><div><ul><li>Strong knowledge of ISO 13485/FDA 21 CFR Parts 803, 806, 820 and ISO 14971 </li></ul></div><div><ul><li>Experience in analyzing quality data and driving root cause determination </li></ul></div></div><div><div><ul><li>Experience with statistics and statistical techniques as it applies to sample size determination, trends, risk management related calculation such as P1 and P2, etc. </li></ul></div><div><ul><li>Experience with project/program management </li></ul></div><div>Nice to Have </div><div><ul><li>Experience in automation and data analysis tools such as Microsoft Excel, VBA, Power BI </li></ul></div><div><ul><li>Experience in test automation and with statistical process controls </li></ul></div><div><ul><li>Black Belt or Master Black Belt certification </li></ul></div><div><ul><li>Experience with statistical process controls </li></ul></div><div><ul><li>Must be self-motivated to complete assigned tasks on time. </li></ul></div><div><ul><li>Must be able to multitask on several assigned projects/assignments </li></ul></div><div><ul><li>Strong communication and presentation skills </li></ul></div><div> </div></div>Physical Job RequirementsThe 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.<h1>Benefits &amp; Compensation  </h1>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):$96,800.00 - $145,200.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).<h2></h2><h2></h2>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:<a href="https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&amp;co_num=30601&amp;co_affid=medtronic" target="_blank">Medtronic benefits and compensation plans</a><h1>About Medtronic</h1><h1></h1>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&amp;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 <a href="http://www.medtronic.com" target="_blank">here</a>.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.<div><div><div><div><div><div><div>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 href="https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/employee-support-services/careers/la-county-legal-notice.pdf" target="_blank">here</a> 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.</div></div></div></div></div></div></div>