Senior Principal PLM IT Business Systems Analyst - Requirements & Risk Management Workstream

| Minneapolis–Saint Paul, MN
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**This role may be filled with a US-based remote resource (work from home). Bring your talents to an industry leader in medical technology and healthcare solutions - we're a market leader and growing every day. You can be proud to be a part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare. Join us for a career in IT that changes lives. Medtronic is committed to fostering a diverse and inclusive culture. Check out the accomplishments of our Women in IT group! http://bit.ly/MedtronicWomeninIT CAREERS THAT CHANGE LIVES We believe that when people from different cultures, genders, and points of view come together, innovation is the result -and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. The Senior Principal IT Business Systems Analyst role carries with it the opportunity to be a part of the Requirements and Risk Management Workstream for the Medtronic Product DNA program. Product DNA is an ecosystem that creates a connected thread of product information, harnessing the collective ingenuity of employees across functions, enabling better collaboration with customers and partners, to rapidly deliver quality products and services, ultimately improving more patients' lives. A DAY IN THE LIFE • Work with the workstream lead to gather business requirements with User Stories. • Document business requirements & functional designs. • Establish backlog of user stories and specify the "WHO, WHAT, WHY" as well as Acceptance Criteria. • Interact and work closely with the business users to understand their technical and business needs. • Ensure applicable compliance and regulatory requirements are recorded. • Oversee testing and defect management process for User Acceptance Testing (UAT). • Participate in Daily Scrum meetings and interface with workstream lead as required for clarifications. • Coordinate demos, conference room pilots and testing. • Support training content creation. • Test functionality of systems to ensure it meets the business user's needs. • Review integration, system, and UAT scripts. • Work w/ testers in the Release Team to validate scripts. • Help build the institutional solution knowledge for long-term business understanding & support. • Work w/ Global Process Lead to update QMS document per process changes. • Work w/Validation Lead to author/update applicable validation documents in conformance with Medtronic System Compliance Methodology (MSCM). MUST HAVE (Minimum Qualifications) • Bachelor's degree • 10+ years of experience with a bachelor's degree or 8+ years of experience with an advanced degree NICE TO HAVE (Preferred Qualifications) • Previous Medtronic experience • Broad multi-functional business and PLM experience • Systems Engineering and Application Lifecycle Management (ALM) • Drive for continuous improvement and a passion to be a change agent • Proven record of impactful contribution to enterprise-wide projects • Must be comfortable with ambiguity, adept at change management, and capable of working in cross functional teams • Excellent facilitation and issue resolution skills • Self-motivated individual with passion to succeed • Experience working in an FDA/ISO regulated environment • Experience with other Product data platforms such as: PLM, ERP, PIM, etc. • Solid experience in requirement and risk management aspects throughout the product lifecycle, related to functional specs to ensure that a product, service, or system meets and fulfills its intended purpose: o The management of requirements by identifying, analyzing, decomposing, allocating and resulting traceability to system components o Communicating and maintaining configuration control of the set of requirements o Risk management through systematic application of management policies, procedures, and practices to the tasks of analyzing, controlling, and monitoring risk. Encompasses hazard analysis, risk analysis and risk control measures o VOX informed design for systematically gathering and interpreting feedback from customers, regulatory sources, competitors, and other stakeholders on the use of a product to guide the development of new, related products, or improvements on an existing product • Experience with requirement gathering and testing in a design control environment • Experience with master data management • Experience driving work across a global, matrixed organization • Strong knowledge and understanding of EU MDR requirements • Financial acumen • Knowledge of Quality Management Systems and Regulatory requirements for compliance 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 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 Day in the Life 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. EEO STATEMENT 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. 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: http://www.uscis.gov/e-verify/employees DISCLAIMER The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Additional Information Posting Date: Jul 6, 2021 Travel: No
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