Senior Business Analyst

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.

Here you will find more than just a jobyou will find purpose and pride.

The Senior Business Analyst plays a critical role in identifying designing and delivering AIenabled solutions that optimize business processes across Medical Quality Regulatory Supply Chain functions within a medical device organization. This role bridges business strategy data science and technology execution ensuring AI initiatives are compliant scalable and aligned with the companys digital transformation roadmap and regulatory requirements (FDA ISO 13485 GxP).

This individual partners closely with crossfunctional teams to translate complex business problems into AIdriven use cases define data and process requirements support solution development manage validation needs and measure impact.

Key Responsibilities

AI Strategy & Opportunity Identification

• Partner with business leaders to identify highvalue AI opportunities in areas such as demand forecasting supply planning manufacturing optimization product quality complaint analytics and regulatory intelligence.

• Conduct feasibility assessments ROI analysis and prioritization of AI initiatives.

• Stay current on emerging AI capabilities generative AI and industry best practices within regulated healthcare environments.

Requirements Gathering & Process Analysis

• Lead detailed discovery sessions to understand business workflows data sources constraints and pain points.

• Translate business needs into clear functional requirements for data science engineering and vendor partners.

• Map currentstate and futurestate processes to identify automation and optimization opportunities.

• Review and analyze user requirements prior to submission and implementation; participate in validation activities as required.

AI Solution Development

• Collaborate with data scientists ML engineers and software developers to define model inputs validation criteria and expected outcomes.

• Support model training testing and iterative refinement to ensure solutions meet business objectives.

• Participate in solution design reviews to ensure usability accuracy interpretability and compliance.

GxP Quality and Compliance

• Ensure solutions comply with QMS requirements data privacy regulations model governance frameworks and validation protocols.

• Support creation of documentation for audits risk assessments and regulatory submissions when necessary.

• Partner with QA/RA teams to implement controls for explainability bias mitigation and ongoing model monitoring.

Change Management & Deployment

• Develop user stories UAT scripts test plans and training materials.

• Lead UAT cycles gather feedback and ensure readiness for golive.

• Drive adoption through ongoing user engagement training and performance monitoring.

• Understand follow and implement appropriate SDLC Computer system Validation quality validation processes and application processes including those specific to AI project lifecycles.

Performance & Value Measurement

• Define KPIs for AI solutions and track postdeployment performance.

• Identify opportunities for continuous improvement and model enhancement.

• Communicate results to leadership in clear business terms.

Qualifications

Required

• Bachelors degree in Business Engineering Computer Science Data Analytics or related field.

• 46 years of experience as a Business Analyst Product Owner Data Analyst or similar role.

• Experience working in a regulated medical device pharmaceutical or healthcare environment.

• Strong understanding of AI/ML concepts data models analytics workflows and system integrations.

• Ability to translate complex business needs into structured requirements and user stories.

• Excellent communication facilitation and stakeholdermanagement skills.

• Familiarity with GxP 21 CFR Part 11 ISO 13485 and validation principles.

Preferred

• Masters degree in Data Analytics Business Engineering or related discipline.

• Experience with generative AI LLMs and prompt engineering.

• Experience with tools such as Azure ML Databricks Snowflake Power BI or AWS Sage maker.

• Understanding of supply chain manufacturing regulatory or quality processes within MedTech.

• Product Owner or Business Analyst certifications (e.g. CBAP CSPO)

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.

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