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.