Senior Principal IT Business Analyst

Job Title: Senior Principal IT Business Analyst

At Medtronic, we're committed to fostering a diverse and inclusive culture. We're seeking a Senior Principal IT Business Analyst to join our Product DNA Execution team.

About the Role

This is a key member of a multi-year Product Lifecycle Management enterprise IT program implementation team with a focus on Regulatory, Design & Engineering, Supplier, or Operations Process related PLM business capabilities.

Responsibilities

• Advises Business Operating Unit / Functions & Business Workstream Leads on how to best design PLM processes / solutions.
• Leads all BA activities related to functional requirements, solution design, process creation, technical documentation, and IT compliance for ALL Program Waves in their PLM Capability/Process area.
• Plays key role in validation activities and usability pilots.
• Strong industry / business knowledge and PLM solution implementation experience required.
• Engages with business leaders to understand how strategies and product data-driven changes can improve efficiencies and add value.
• Evaluate current business processes and identify complex business problems and translate those needs into how those needs can be satisfied within Medtronic's PTC Windchill PLM solution.
• Partners with various IT teams to design technology solutions that align with Enterprise Architecture strategy and standards, are compliant with GSO and Data Privacy, or other applicable regulations, and IT processes.
• Provides technical expertise for system functional specifications and deploys new and current systems, processes, and procedures in a cost-effective manner leveraging PTC Windchill as PLM solution.
• Advises business team members on business process options.
• Oversees cross-functional teams to address business/systems issues or project.
• Interacts with internal and external customers and vendors at various levels.
• Manages stakeholders' expectations and provides briefings to senior leaders.
• Facilitates discussions to negotiate and reach understanding or agreements to solve business and technical challenges in the most optimal way.
• Facilitates interviews to gather requirements, document current process, and design future state.
• Collaborate with IT Business Relationship Manager (BRM), business stakeholders and IT Product Owners / Managers to develop business requirements for product or system changes.
• Translates and documents business requirement(s) into Functional Specifications.
• Drives business agenda during solution delivery process.
• Responsible for technical solution delivery.
• Establish backlog of user stories and specify the "WHO, WHAT, WHY" as well as Acceptance Criteria.
• Ensure applicable compliance and regulatory requirements are recorded.
• Oversee testing and defect management process for User Acceptance Testing (UAT).
• Coordinate demos, conference room pilots and testing.
• Support training content creation.
• 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).

Requirements

• High school diploma (or equivalent) and 12+ years of experience.
• OR
• Bachelor's degree and 10+ years of experience or advanced degree and 8+ years of experience.

Preferred Qualifications

• Strongly Preferred:
• Multiple complete Product Lifecycle Management (PLM) implementations.
• Experience configuring PLM applications (Windchill experience preferred).
• Proven experience in leading the shaping of business requirements, designing solutions to meet the requirements, educating business stakeholders on system capabilities and options to improve business processes.
• Ability to create technical specifications to document business requirements.
• Ability to troubleshoot technical and configuration issues within PLM applications.
• Strongly Preferred Data/Process/Systems Knowledge & Experience:
• Solid experience with activities throughout the product lifecycle, related to requirements and 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 components.
• Maintaining configuration control and Risk management through systematic application of management policies, procedures, and practices to the tasks of analyzing, controlling, and monitoring risk.
• 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.
• Product Development Process, Enterprise Change Control, Design Control, Supplier Control, and related Regulatory aspects.
• Corrective & Preventive Action (CAPA), Issue Impact Assessment (IIA) and Non-Conformance Integration.
• Document approval and Document change management for Quality Management System (QMS).
• Experience with master data management.
• 7+ years of professional experience in the healthcare industry strongly preferred.
• MedTech experience.
• Experience with patient data and clinical reporting.
• Knowledge of pre/post market surveillance and real-world evidence.
• Strong knowledge and understanding of EU MDR requirements.
• Strong technical aptitude and knowledge on latest technology trends.
• Strong interpersonal, oral, presentation, and written communication skills.
• Ability to work collaboratively. Excellent facilitation and issue resolution skills.
• Proven record of impactful contribution to enterprise-wide projects.
• Able to adapt to ambiguity, adept at change management, and capable of working in cross functional teams.
• Drive for continuous improvement and a passion to be a change agent.
• Experience driving work across a global, matrixed organization.
• Experience working in an FDA/ISO regulated environment.
• Experience with other Product data platforms such as PLM (Enovia, Agile PLM, Windchill), ERP, PIM, etc.
• Knowledge of Quality Management Systems (QMS).

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package.

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Medtronic benefits and compensation plans (https://www.medtronic.com/us-en/about-medtronic/careers/benefits.html)

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here (https://www.medtronic.com/us-en/about-medtronic/careers/diversity.html)

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.

At Medtronic, most positions are posted on our career site for 3-7 days.

Welcome to our new Careers Site

If you applied before July 22nd, please check your email for a notification from us providing you with instructions and a link to set up your new account and retain access to your current activity. If you do not see an email from us, please feel free to proceed with creating a new account.

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

We change lives

. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

We build extraordinary solutions as one team

. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life-changing career is yours to engineer

. By bringing your ambitious ideas, unique perspective and contributions, you will...

Build

a better future, amplifying your impact on the causes that matter to you and the world

Grow

a career reflective of your passion and abilities

Connect

to a dynamic and inclusive culture that welcomes the challenge of life-long learning

These commitments set our team apart from the rest:

Experiences that put people first

. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

Life-transforming technologies

. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world

. Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care

. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

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.

For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

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 (https://www.e-verify.gov/)

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