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** Support AST Advanced Energy and Lung Health products RPE Quality role. **Careers that Change Lives** In this exciting role as a Senior Quality Engineer, you will have responsibility for providing risk management expertise and best practices for released products and post-market activities within the Advanced Surgical Technologies organization. This includes evaluating product issues to ensure patient, user and security risk are assessed, and acting as the lead Design Quality Engineer for post-market design changes on capital hardware and disposable products. **A Day in the Life** Provide comprehensive support to Post Market Development Teams with a focus on Design Quality and Risk Management. Responsibilities may include the following and other duties may be assigned. + Collaborate with different departments across the organization to understand and review data to assess the patient/user risk associated with the post market life-cycle phase. + Conduct health hazard assessments for fielded products. + Conduct Corrections & Removals assessments. + Collaborate cross functionally to perform bounding/scoping for product field issues and related regulatory inquiries. + Assess risks that were not previously identified, as well as potential risks associated with changes in therapy, systems, products, components, manufacturing processes, + Collaborate with Medical Safety and Complaint Handling to review and analyze field data, discuss the harm severity sources and estimate the probability or harm occurrence. + Support Complaint trending and Severity trending signal dispositions. + Maintain risk management file throughout product lifecycle, ensuring the latest knowledge on risk reflected in the risk documentation. + Actively communicate findings to Quality, Development, and Operations teams and escalates when the risk profile of a medical device adversely changes. + Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. + Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. + Assure compliance to organizational procedures, regulatory requirements,timely completion of assigned corrective and preventive actions and audit findings. + Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. + Can assess and prioritize work, balance focus on current/future needs, and triage urgent issues + Coordinate activities through the Quality Engineering Manager and report regularly on the progress of activities. + Participate in meeting departmental goals and objectives. **Must Have:** **Minimum** **Requirements** + Bachelor’s degree required + Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years relevant experience **Nice to Have** + Excellent communication and technical writing skills + Experience in Manufacturing and/or Electro-Mechanical Medical Devices + Experience in a technology discipline within Engineering, Research & Development, or Sustaining existing technology/ products + Six-Sigma greenbelt or blackbelt certification + Working knowledge of Quality System Regulation (QSR 21 CFR 820) and EU Medical Device Directive (EU MDD 93/42 EEC) + Understanding of Risk Management in accordance with ISO 14971 + General understanding of Design controlsin accordance with ISO 13485 + General understanding of GMP/GDP + Familiarity with Supplier Qualification activities + Experience with front room and/or back roomcompliance audit support + Familiarity with Statistical analysis (capability, TMV, appropriate sample size determination) + Ability to interact with cross functional team members across multiple sitesto create partnerships + Proven track record in identifying, evaluating, planning, and executing solutions to complex technical problems across more than one product line, business or geography **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. Salary ranges for U.S (excl. PR) locations (USD):$94,400.00 - $141,600.00 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). Medtronic benefits and compensation plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page\_name=signon&co\_num=30601&co\_affid=medtronic) **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 90,000+ 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 (http://www.medtronic.com) . 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. At Medtronic, most positions are posted on our career site for 3-7 days. **Welcome to our new Careers Site!** **If you applied before July 22nd, please check your email for a notification from us providing you with instructions and a link to set up your new account and retain access to your current activity. If you do not see an email from us, please feel free to proceed with creating a new account.** 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 90,000+ 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. **We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. **We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. **This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will… + **Build** a better future, amplifying your impact on the causes that matter to you and the world + **Grow** a career reflective of your passion and abilities + **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: **Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. **Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. **Better outcomes for our world** . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. **Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care 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. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) . For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email AskHR@medtronic.com To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com