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Careers that Change LivesA Day in the Life· Responsible for ensuring that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulations and EU MDD / MDR requirements.· Responsible for approving product requirements and new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, and reliability.· Participate on cross-functional teams to develop and maintain Product Risk Management Files (Risk Management Plan, Risk Assessments, DFMEA and Risk Management Report) and facilitate Post Launch Risk Management Reviews.· Participate in the development of Design Verification and Validation test plans / protocols and provide guidance on Product Requirements compliance. Participate in Engineering Design Reviews.· Provide guidance and direction for sample size and statistical analysis of Verification and Validation testing.· Provide training to project teams on all Quality Policies / Procedures (including verification, validation, statistical methods, and design controls), when necessary.· Provide Quality support to facilitate the rapid resolution of Product Complaints and/or Patient Safety issues.· Review Design History Files and Technical Files for conformance to applicable requirements and support the Regulatory Department in reviewing technical submissions.Must Have: Minimum Requirements· Responsible for ensuring that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulations and EU MDD / MDR requirements.· Responsible for approving product requirements and new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, and reliability.· Participate on cross-functional teams to develop and maintain Product Risk Management Files (Risk Management Plan, Risk Assessments, DFMEA and Risk Management Report) and facilitate Post Launch Risk Management Reviews.· Participate in the development of Design Verification and Validation test plans / protocols and provide guidance on Product Requirements compliance. Participate in Engineering Design Reviews.· Provide guidance and direction for sample size and statistical analysis of Verification and Validation testing.· Provide training to project teams on all Quality Policies / Procedures (including verification, validation, statistical methods, and design controls), when necessary.· Provide Quality support to facilitate the rapid resolution of Product Complaints and/or Patient Safety issues.· Review Design History Files and Technical Files for conformance to applicable requirements and support the Regulatory Department in reviewing technical submissions.About MedtronicTogether, 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 RequirementsThe 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. (ADA-United States of America)Min Salary90000Max Salary135000It 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.
