LIMS Business Analyst (United States)

Senior Business Analyst

Who we are: -

At CitiusTech , we constantly strive to solve the industry's greatest challenges with technology, creativity, and agility. With over 8,500 healthcare technology professionals worldwide, CitiusTech powers healthcare digital innovation, business transformation, and industry-wide convergence for over 140 organizations through next-generation technologies, solutions, and products. We aim to accelerate the transition to a human-first, sustainable, and digital healthcare ecosystem with the world's leading Healthcare and life sciences organizations and our partners.

Here is an opportunity for you to make a difference and collaborate with global leaders to shape the future of healthcare and positively impact human lives.

Our vision: -

To inspire new possibilities for the health ecosystem with technology and human ingenuity.

What is in it for you?

Senior Business Analyst responsible for driving product requirements, backlog governance, stakeholder collaboration, and onsite-offshore delivery coordination for regulated Laboratory Diagnostics, Medical Device, and IVD solutions.

Responsibilities: -

• Lead requirement gathering, analysis, clarification, prioritization, and change-impact assessment across business and technology teams.
• Own and maintain PRD, SRS, business workflows, user journeys, and Requirements Traceability Matrix (RTM).
• Manage Epics, Features, functional User Stories, Acceptance Criteria, and Azure DevOps backlog readiness.
• Facilitate refinement sessions and coordinate requirements between onsite client stakeholders and offshore delivery teams.
• Partner with the Client Product Owner on prioritization, release planning, demos, scope management, and story acceptance.
• Support V&V functional reviews, UAT coordination, defect business-impact assessments, and QARA activities.
• Coordinate with Product, Architecture, Engineering, QA, Clinical, Regulatory, and Technical Publications teams to ensure successful product delivery.
• Act as the onsite Proxy Product Owner and primary bridge between client stakeholders and offshore delivery teams.
• Drive business validation, requirements traceability, and functional alignment throughout the software development lifecycle.

Experience: -

• 10+ Years

Location: -

• Remote

Educational Qualifications: -

• Engineering Degree – BE/ME/BTech/MTech/BSc/MSc.
• Technical certification in multiple technologies is desirable.

Skills: -

Mandatory skills

• 10+ years of experience in Business Analysis, Product Ownership, or Healthcare Product Delivery.
• Strong experience working within Medical Devices, In-Vitro Diagnostics (IVD), or Laboratory Diagnostics domains.
• Hands-on understanding of diagnostic instruments, clinical analyzers, laboratory middleware, and instrument connectivity.
• Strong knowledge of laboratory workflows including sample processing, quality control (QC), calibration, test execution, result validation, and reporting.
• Experience with LIS/LIMS platforms and healthcare interoperability standards such as HL7 and ASTM; familiarity with FHIR preferred.
• Working knowledge of FDA Design Controls, IEC 62304, ISO 13485, Design History File (DHF), Requirements Traceability Matrix (RTM), Risk Management, and Verification & Validation (V&V) processes.
• Experience managing product backlogs, Epics, Features, User Stories, Acceptance Criteria, and release planning activities.
• Proficiency with Azure DevOps or Jira, Confluence, process-mapping tools, and API concepts.
• Strong stakeholder management, requirements elicitation, facilitation, documentation, decision-making, and communication skills.
• Proven experience coordinating cross-functional teams across Product, Engineering, QA, Clinical, Regulatory, and business functions.

Good to Have Skills

• Blood Banking and Transfusion Medicine.
• Immunohematology.
• Clinical Chemistry.
• Molecular Diagnostics.
• Point-of-Care Testing.
• Laboratory Automation.
• Experience working as an onsite client-facing Product Owner or Proxy Product Owner.
• Exposure to regulated healthcare product development environments.

Life at CitiusTech

We focus on building highly motivated engineering teams and thought leaders with an entrepreneurial mindset, centered on our core values of Passion, Respect, Openness, Unity, and Depth (PROUD) of knowledge . Our success lies in creating a fun, transparent, non-hierarchical, diverse work culture that focuses on continuous learning and work-life balance.

Rated by our employees as the ‘Great Place to Work for’ according to the Great Place to Work survey. We offer you a comprehensive set of benefits to ensure that you have a long and rewarding career with us.

Our EVP

Be You Be Awesome is our EVP and it reflects our continuing efforts to create CitiusTech as a great place to work where our employees can thrive, both personally and professionally. It encompasses the unique benefits and opportunities we offer to support your growth, well-being, and success throughout your journey with us and beyond. Together with our clients, we are solving some of the greatest healthcare challenges and positively impacting human lives. Welcome to the world of Faster Growth, Higher Learning, and Stronger Impact.

Join CitiusTech. Be You. Be Awesome.

To learn more about CitiusTech, visit and follow us

Skills

Business Analysis | Laboratory Diagnostics | Medical Devices | IVD | LIS/LIMS | HL7 | ASTM | FDA Design Controls | IEC 62304 | ISO 13485 | Azure DevOps