Senior Business Analyst - Medical, Healthcare, LifeSciences

📋 Description

• • Own the end-to-end product backlog for high-impact medical, healthcare, and life-sciences solutions, translating complex clinical workflows, regulatory mandates, and patient-care objectives into a clear, prioritized roadmap that drives measurable business value.
• • Serve as the primary bridge between business stakeholders (hospital administrators, payers, clinicians, regulatory bodies) and cross-functional engineering squads—ensuring every feature, user story, and acceptance criterion is grounded in real-world medical practice and compliant with FDA, HIPAA, GDPR, and other relevant standards.
• • Write, refine, and decompose epics into granular user stories that are INVEST-compliant (Independent, Negotiable, Valuable, Estimable, Small, Testable), embedding traceability to regulatory requirements and clinical evidence so that each increment can be audited and validated.
• • Lead backlog grooming and prioritization sessions using WSJF (Weighted Shortest Job First) and value-risk matrices, balancing urgent patient-safety fixes, long-term strategic initiatives, and technical debt to maximize ROI and maintain system reliability.
• • Facilitate PI Planning within a SAFe 5.x framework, collaborating with Release Train Engineers, architects, and DevOps teams to sequence features across multiple Agile Release Trains while highlighting cross-team dependencies, capacity constraints, and regulatory submission timelines.
• • Champion transparency by publishing living roadmaps, dependency maps, and risk registers in Jira Align or similar tools, ensuring executives, medical affairs, and QA teams always have an accurate view of scope, velocity, and compliance posture.
• • Validate every deliverable against pre-defined acceptance criteria and clinical test cases, coordinating user-acceptance testing with physicians, nurses, pharmacists, and patients to confirm usability, safety, and efficacy before release.
• • Drive continuous process improvement by analyzing post-release metrics (adoption rates, adverse-event reports, audit findings) and leading Kaizen events that reduce cycle time, eliminate waste, and enhance patient outcomes.
• • Partner with regulatory-affairs and quality-assurance teams to ensure that software increments meet 21 CFR Part 820, ISO 13485, and IEC 62304 standards, maintaining a living traceability matrix that links requirements, design, code, tests, and risk controls.
• • Support release planning and deployment governance, coordinating with DevOps to implement blue-green or canary releases that minimize downtime in clinical environments and enable rapid rollback in the event of patient-safety issues.
• • Mentor junior analysts and product owners on domain-specific nuances—such as HL7 FHIR, DICOM, LOINC, and SNOMED CT—fostering a culture of clinical literacy and regulatory rigor across the product organization.
• • Identify and quantify new value opportunities through market research, competitive benchmarking, and voice-of-customer interviews, translating insights into data-backed business cases that secure funding and executive sponsorship.
• • Collaborate with data-science teams to embed AI/ML capabilities (predictive risk scoring, clinical decision support, population-health analytics) while ensuring algorithmic transparency, bias mitigation, and regulatory approval pathways.
• • Maintain a deep understanding of emerging trends—telehealth, digital therapeutics, SaMD (Software as a Medical Device), and value-based care models—positioning the product to capitalize on shifts in reimbursement and patient expectations.
• • Present quarterly business reviews to C-suite and medical advisory boards, articulating progress against OKRs, regulatory milestones, and patient-outcome KPIs, and securing strategic alignment for the next PI.