Job Description

Careers that Change LivesWe believe that when people from different cultures, genders, and points of view come together, innovation is the result \xe2\x80\x94and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.Bring your talents to an industry leader in medical technology and healthcare solutions \xe2\x80\x93 we\xe2\x80\x99re 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.The candidate should be a seasoned SAP professional with a proven track record in navigating both ECC and S/4HANA landscapes. Their expertise should extend to platform capabilities, architecture, project leadership, security, and compliance, ensuring the effective and optimal utilization of SAP systems to drive business success.
A Day in the Life Lead the planning, design, and execution of SAP quality assurance (QA) and testing activities in compliance with FDA regulations and guidelines, ensuring the integrity and reliability of systems supporting regulated processes. Develop and maintain test documentation, including test plans, test cases, test scripts, and validation protocols, to verify the functionality, performance, and security of SAP systems undergoing S/4HANA transformation and ECC enhancements. Coordinate with cross-functional teams, including business analysts, developers, and project managers, to define testing requirements, identify test scenarios, and prioritize test execution based on business criticality and regulatory requirements. Establish and maintain traceability between testing artifacts and regulatory requirements, ensuring that testing activities are aligned with FDA validation principles and standards. Implement and maintain automated testing frameworks and tools for regression testing of SAP applications, leveraging industry best practices and continuous integration/continuous deployment (CI/CD) pipelines. Conduct risk-based testing assessments to identify and mitigate potential risks to system quality, data integrity, and regulatory compliance throughout the S/4HANA transformation and ECC enhancement lifecycle. Monitor and report on test progress, defects, and quality metrics to project stakeholders, providing timely updates on testing status and highlighting any issues or risks impacting project timelines or deliverables. Coordinate user acceptance testing (UAT) activities with business stakeholders, ensuring that UAT scripts are developed and executed according to defined acceptance criteria and FDA validation requirements. Collaborate with IT infrastructure and security teams to ensure that testing environments are properly configured and secured to support SAP QA and validation activities in compliance with FDA regulations. Provide leadership and mentorship to QA and testing team members, fostering a culture of quality excellence, continuous improvement, and knowledge sharing within the organization. Stay current with SAP technologies, FDA regulations, and industry trends related to quality assurance and testing in regulated environments and apply this knowledge to drive innovation and efficiency in testing processes. Participate in audits and inspections by regulatory agencies or internal quality assurance teams, ensuring that testing documentation and processes adhere to FDA validation principles and standards. Travel to client sites or project locations as needed to support SAP QA and testing activities and engage with project teams and stakeholders.Must Have: Minimum Requirements 14+ years of experience with a bachelor\xe2\x80\x99s degree or 8+ years of experience with an advanced degree. Minimum of 5 years of experience in SAP quality assurance (QA) and testing, with a focus on S/4HANA transformation and ECC enhancements in FDA-regulated environments. Expertise in developing and maintaining test documentation for SAP systems, including test plans, test cases, and validation protocols, in compliance with FDA regulations and guidelines. Proficiency in any SAP testing tools and methodologies, such as SAP Solution Manager, HP ALM and Tricentis (Application Lifecycle Management), or similar tools for test management and defect tracking. Hands-on experience with automated testing frameworks and tools for SAP applications, such as HP UFT (Unified Functional Testing), Selenium, or similar tools for regression testing. Experience coordinating user acceptance testing (UAT) activities with business stakeholders, ensuring that UAT scripts are developed and executed according to defined acceptance criteria. Experience working across US and multiple time zones. Excellent communication skills with the ability to collaborate effectively with cross-functional teams and stakeholders in a regulated environment.Nice to Have Previous Medical devices and/or Pharma experience Strong understanding of FDA validation principles and standards for computerized systems in regulated environments, including 21 CFR Part 11 compliance requirements. Knowledge of SAP technologies and modules, with a focus on S/4HANA and ECC, including SAP modules relevant to FDA-regulated processes (e.g., QM, PP, PM). Familiarity with IT infrastructure and security requirements for SAP testing environments in FDA-regulated environments, including data integrity, access controls, and audit trails.
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\xe2\x80\x99s work together to address universal healthcare needs and improve patients\xe2\x80\x99 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)#MEICITJOBSAdditional Information

• Posting Date: Mar 22, 2024
• Travel: No

Medtronic