What are the responsibilities and job description for the Business Requirements Analyst position at Tranzeal Incorporated?
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.