Principal System Engineer
Genentech, Inc
San Jose
hace 5 días

As a Principal System Engineer, you will be responsible for analyzing and managing the technical and functional requirements for software projects in support of Roche’s on-market IVD software products and Roche’s CAP / CLIA laboratory.

You will also manage technical and change control reviews, and traces all software requirements and specification documents in the requirements management tool.

You will work closely with the System Engineers, Software Developers, and Software Test Engineers to maintain alignment with the established customer and product requirements at each point in the development process.

Job Description : Defines software technical requirements and prepares written specifications and documentation according to standard templates, using a simplified language methodology.

Breaks down high level feature requirements and Use Case specifications into functional requirements to an appropriate level of detail suitable for use by System Engineers and Verification testers.

Defines quality attributes, external interfaces, constraints, and other nonfunctional requirements. Represents system interaction requirements using alternative views.

Creates and manages risk registers, and traces matrices. Leads peer reviews and inspections of requirements documents. Leads peer reviews of work products derived from requirements specifications to ensure that the requirements were interpreted correctly.

Enters, manipulates, and reports on requirements stored in a requirements management tool. Defines requirement attributes and facilitates their use throughout the project.

Manages requirements traceability information and tracks requirements status throughout the project. Manages changes to baselined requirements through effective application of change control processes and tools.

Implements effective requirements practices, including use and continuous improvement of a requirements process. Assists with the development of the organization’s requirements engineering policies, procedures, and tools.

Leads efforts in finding ways to reuse requirements across projects. Qualifications : BS degree in Computer Science, Biomedical Engineering, Electrical Engineering, or equivalent in a directly related discipline 5+ years of industry engineering experience Experience in a regulated software product development environment preferred.

In-depth knowledge of systems engineering processes Experience with requirements management tools Knowledge of contemporary requirements elicitation, analysis, specification, and verification and the ability to apply them in practice.

Ability to practice requirements engineering according to development life cycles in a team environment. Ability to critically evaluate information from multiple sources, reconcile conflicts and break down high level information into details.

Strong product sensibility, with the ability to translate customer needs into pragmatic solutions Strong communication skills, with the ability to explain complex technical problems to non-technical audiences Strong interpersonal skills, with proven ability to navigate complex corporate environments and influence stakeholders and partners Experience in healthcare is not required, but familiarity with healthcare systems and data and workflows is a plus

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