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medical device Systems Analyst

1 month ago

Alameda, United States KYYBA Full time
Job DescriptionJob Description

·        Responsible for configuration of IBM Rationale SaaS systems, specifically DOORS Next Gen (DNG) and Engineering Test Management (ETM). –

·        Must have significant experience leading implementation and configuration of those systems. - Including project management, working cooperatively with subject matter experts, knowledge and implementation of best practices of medical device product development utilizing the specific IBM systems. –

·        Nice to have additional expertise in medical devices computer systems validation and 21 CFR Part 11 requirements.

Additional description:

·        Responsible for configuration and management of DOORS, DOORS NG, and IBM Publishing Engine.

·        Must have experience leading implementation and configuration of those systems.

·        Including project management, working cooperatively with subject matter experts, knowledge and implementation of best practices utilizing the specific systems.

·        Nice to have additional experience with ETM.

·        Nice to have additional expertise in medical devices product development or medical devices computer systems validation and 21 CFR Part 11 requirements.

·        No degree requirement

·        Working for R&D in a remote position, primarily self-directed day to day

·        Working R&D and QA stakeholders who interact with the system

Minimum 5 years experience