The SOFTWARE PRODUCT ANALYST (Software Requirements Engineer) creates product specifications based on customer and stakeholder requirements for the development of new products or changes to existing products.
* Elicit requirements using interviews, document analysis, requirements workshops, storyboards, site visits, business process descriptions, use cases, scenarios, and/or task and workflow analysis.
* Write requirements specifications according to standard templates, using natural language simply, clearly, unambiguously, and concisely.
* Lead requirements analysis and verification, ensuring that requirement statements are complete, consistent, concise, comprehensible, traceable, feasible, unambiguous, and verifiable, and that they conform to documented processes and standards.
* Perform complex research, analysis, and documentation.
* Perform validation of functional requirements, use cases, workflows, and data models.
* Participate in requirements prioritization.
* Participate in peer reviews and inspections of requirements documents.
* Participate in peer reviews of work products derived from requirements specifications to ensure that the requirements were interpreted correctly.
* Enter, manipulate, and report on requirements stored in a commercial requirements management tool.
* Manage requirements traceability information and track requirements status throughout the project.
* Identify requirements errors and defects, and write requirements defect reports.
* Manage changes to baselined requirements through effective application of change control processes and tools.
* Establish and implement effective requirements practices, including use and continuous improvement of a requirements process. Assist with the development or improvement of the organization’s requirements engineering policies, procedures, and tools.
* Implement ways to reuse requirements across projects and products.
* An understanding of contemporary requirements elicitation, analysis, specification, verification, and management practices, and the ability to apply them in practice; familiarity with requirements engineering literature and resources.
* An understanding of how to practice requirements engineering according to several software development life cycles in a team environment.
* Knowledge of product management concepts and how enterprise software products are positioned and developed.
* Interviewing skills, to talk with individuals and groups about their needs and ask the right questions to surface essential requirements information.
* Listening skills, to understand what people say and to detect what they might be hesitant to say.
* Analytical skills, to critically evaluate the information gathered from multiple sources, reconcile conflicts, decompose high-level information into details, abstract up from low-level information to a more general understanding, distinguish presented user requests from the underlying true needs, and distinguish between solution details and requirements.
* Facilitation skills, to lead requirements elicitation workshops.
* Observational skills, to validate data obtained via other techniques, such as site visits, and expose new areas for elicitation.
* Modeling skills, to represent requirements information in graphical forms that augment textual representations in natural language. Candidates must have knowledge and (preferably) experience with at least three of the following line items:
o Use cases
o Context Diagrams
o Decision Tables / Decision Trees
o Activity Models (also called Workflow Diagrams or Process Maps)
o State Diagrams
* Writing skills, to communicate information effectively to the department’s customers and stakeholders.
* Organizational skills, to work with the array of information gathered during elicitation and analysis and to cope with rapidly changing information.
* Interpersonal skills, to help negotiate priorities and to resolve conflicts among project stakeholders (such as customers, product management, and engineering).
Knowledge and skill of any of the following items is a plus
* FDA Design Control regulations, and associated standards and guidances
* Microsoft Team Foundation Server
* DOORS Requirements System
* Experience with medical diagnostic devices / analyzers
* Experience on an Agile/Scrum team
* IREB Certification (or the equivalent)
* Database fundamentals
* Communication protocols, such as POCT1A, HL7, ASTM
* Statistical Data Analysis
* BS/MS in Computer Science or Engineering, or 5-8 years of successful experience in a related field and the successful demonstration of Key Responsibilities, Knowledge and skills as presented above.
* An appropriate advanced degree may be substituted for experience, where applicable.