Mounds View, Minnesota, us Business and Financial Operations Occupations
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This Sr IT Principal 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.
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 while 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).
Bachelor’s degree with 10+ years of experience with or 8+ years of experience with an advanced degree
Relevant experience including:Broad multi-functional business and PLM experienceSystems Engineering and Application Lifecycle Management (ALM).
Drive for continuous improvement and a passion to be a change agent.
Must be comfortable with ambiguity, adept at change management, and capable of working in cross functional teams.
Experience working in an FDA/ISO regulated environment.
Experience with other Product data platforms like: 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,including:The management of requirements by identifying, analyzing, decomposing, allocating and resulting traceability to system componentsCommunicating and maintaining configuration control of the set of requirementsRisk 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 measuresVOX 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, and driving work across a global, matrixed organization.
Previous Medtronic experience
Preference given to current Medtronic employees
Priority consideration will be given to local applicants
Strong knowledge and understanding of EU MDR requirements.
Knowledge of Quality Management Systems and Regulatory requirements for compliance.