System Engineer

Duties Responsibilities: Key Words “ to search -Sr. System Engineer - Rational DOORS database, Agile development framework, Requirement management, Rationale publishing engine Mechanical, manage project requirements, Medical device products, Perform data acquisition, Manage requirements traceability information. Job Role ● This role is responsible for creating and maintaining the system and subsystem requirements for a complex project that is underway. A large portion of the requirements are already developed and in the requirements software tool. The project is in the stage of reviewing, identifying gaps, and clarifying the requirements as the project progresses. This project utilizes an Agile development framework, and this position will be part of a dedicated team to manage project requirements. ● Accessing, creating, and revising requirements the DOORS software tool. ● Understanding the product technical specifics sufficiently interfacing with subject matter experts, designers, developers, and project stakeholders to define and clarify requirements. ● Understanding the product architecture as well as the requirements hierarchy to insure proper requirements decomposition and linkages. ● Using templates to publish using Rationale publishing engine to create word documents for the design history file ● Complying with the applicable Requirements Management and Document Management Multi-Site Work Instructions. ● Manage requirements traceability information and track requirements status throughout the project. ● Knowledge needed -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 Product development life cycles in a team environment. ● A solid working knowledge of the IBM requirements management tool DOORS to create product structures and build and maintain them. ● Navigate within a Rational DOORS database. ● Create, modify, and review structured data in a Rational DOORS formal module. ● Create and report link relationships in a Rational DOORS database. ● Create reports on relationships in a Rational DOORS database. ● Apply change control, configuration management, and backup strategies to DOORS data. ● Familiarity with agile development practices Skills needed ● Analytical skills, to critically evaluate the information gathered from multiple sources, to develop optimized requirements. ● Observational skills, to validate data where applicable, and expose new areas for elicitation. ● Writing verbal skills, to communicate information effectively to the team’s customers and stakeholders. ● 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 guidance ● Experience with medical diagnostic devices / analyzers ● Database fundamentals ● Networking Experience ● 5-8 years of successful experience in a related field and the successful demonstration of key responsibilities, knowledge and skills as presented above. ● Demonstrated use of and proficiency in DOORS. ● Requirements management practice for complex products.