This is where your work makes a difference.
At Baxter, we believe every person—regardless of who they are or where they are from—deserves 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 job—you will find purpose and pride.
The Senior Business Analyst plays a critical role in identifying, designing, and delivering AI‑enabled 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 company’s digital transformation roadmap and regulatory requirements (FDA, ISO 13485, GxP).
This individual partners closely with cross‑functional teams to translate complex business problems into AI‑driven 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 high‑value 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 current‑state and future‑state 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 go‑live.
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 post‑deployment performance.
Identify opportunities for continuous improvement and model enhancement.
Communicate results to leadership in clear business terms.
Qualifications
Required
Bachelor’s degree in Business, Engineering, Computer Science, Data Analytics, or related field.
4–6+ 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 stakeholder‑management skills.
Familiarity with GxP, 21 CFR Part 11, ISO 13485, and validation principles.
Preferred
Master’s 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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