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Associate Risk Management Engineer

3 months ago

Fridley, United States Medtronic Full time

**Careers That Change Lives** A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people. Help us engineer the extraordinary Help bring the next generation of life-changing medical technology to patients worldwide. We reward you in the ways that matter most to you. We offer a wide range of benefits and rewards programs to recognize the important role you play in our Mission to transform healthcare. Learn more about Medtronic benefits and compensation at the bottom of this job description. We are currently looking for an **Associate Risk Management Engineer** to join Medtronic Neuromodulation and Pelvic Health to drive the development of safe and effective implantable medical systems and support sustaining activities. **Location:** This position will be a hybrid role with the expectation of being onsite in **Fridley, Minnesota** three days a week. **A Day in the Life** In this critical role as an **Associate Risk Management Engineer** , you will work closely with multidisciplinary project teams to develop products that are safe and effective for the patients and users by evaluating and driving improvements in the design, reliability, and safety. You will also engage in sustaining activities to support products and systems throughout the lifecycle. This role is people oriented, requiring excellent collaboration and communication skills; it also requires persnickety attention to detail. Responsibilities may include but are not limited to: + Maintain a thorough knowledge and understanding of ISO 14971 and risk management practices, such as Hazard Analysis and Failure Mode and Effects Analysis. + Collaborate with cross-functional teams (including Design, Human Factors, Medical Safety, Reliability and Post-Market Quality) to ensure that all hazards associated with medical devices are identified, the associated risks are estimated, evaluated, and that product/system performance is quantifiably predicted. + Work with project teams to ensure that risk controls are identified and properly implemented, verified, and validated. + Evaluate impact of potential issues to patient safety and product performance + Perform and document Risk Reviews to communicate results of the risk management process to the cross-functional teams. + Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk Management team members that share in varying pieces of the risk management lifecycle. + Identify and act upon opportunities for continuous improvement of the Risk Management Process + Provide input to design/process development, design controls, and design validation for achieving required levels of product safety and performance. + Create documentation in compliance with applicable procedures to meet project deliverables. **Must Have: Minimum Requirements** _To be considered for this role, please ensure the minimum requirements are evident in your applicant profile and on your resume._ + Bachelor’s degree in Engineering or technical discipline + 0 years of experience required. **Nice to Have** + Experience in the application of statistics. + Experience in a highly regulated industry, preferably implantable medical devices. + Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc. + Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HA, FTA, DFMEA). + Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms. + Exposure to or experience working in or with Design, Quality, Regulatory, Clinical and/or Manufacturing + Knowledge of Design for Reliability (DfR), Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), and/or robust design practices. **About Medtronic** Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future. Physical Job Requirements 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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America). Min Salary 65600 Max Salary 98400 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.