Business Requirements Analyst

Job Title: Software Requirements & Product Risk Analyst Location: Tucson, AZ About the Role We are seeking a detail-oriented Software Requirements & Product Risk Analyst to support end-to-end product delivery within a regulated environment. The ideal candidate will have strong experience in writing software requirements, defining product specifications, and performing comprehensive product risk analyses. This role requires effective collaboration with cross-functional teams as well as the ability to work independently to drive clarity and alignment throughout the product lifecycle. Key Responsibilities • Develop clear, detailed, and traceable software requirements and product specifications for new and on-market products. • Perform product risk analysis, identify potential hazards, and work with engineering and quality teams to define mitigations. • Collaborate with cross-functional stakeholders (Engineering, QA, Product, Regulatory, Customer Support) to gather needs and perform trade-off analyses. • Create and update Lucid Charts, process flows, and system diagrams to support design clarity. • Work within the SAFe Agile framework, participate in ceremonies, and maintain accurate work items in Azure DevOps. • Ensure all requirements, risk artifacts, and documentation comply with regulatory and quality standards for medical device development. Required Skills & Qualifications • Bachelor’s degree in Engineering, Computer Science, Biomedical Engineering, or related field. • Proven experience writing software requirements and defining detailed product specifications. • Strong background in product risk analysis, hazard identification, and regulatory compliance (preferably in medical devices). • Hands-on experience working in a regulated industry (FDA, ISO 13485, IEC 62304 preferred). • Proficiency with Lucid Charts, process maps, and system diagramming tools. • Familiarity with SAFe Agile methodology and experience using Azure DevOps for requirements and backlog management. • Ability to work collaboratively across teams and independently with minimal oversight. • Strong analytical, documentation, and communication skills.