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Position : Data Engineer 3

Duration : 12 Months

Location : Sunnyvale, California, USA

Description
Primary Function of Position:
The data steward is responsible for execution of our UDI global data and GLM management strategy. The Data Steward will also play a key role in data integrity of our Agile UDI submission tool and being an integral part of future expansion of UDI, Labeling, and global data attribute needs (EUDAMED, GDSN, etc).

Roles and Responsibilities:
Act as expert for proper Agile UDI attribution and maintain data integrity.
Review, maintain, and correct UDI data attributes.
Partner with engineering, global labeling, regulatory, and PMO on proper attribute work flows and entry points.
Work with software teams to implement new attributes or improvements to existing system and work flows.
Expert in GTIN enumeration and practices as part of UDI & Basic UDI-DI attributes for EU MDR.
Work on Global labeling management software project to help support data driven labeling.
Maintain knowledge of existing and emerging regulations, standards, and guidance documents related to global UDI and GLM
Recommend changes to data attributes in response to regulations or standards UDI and GLM
Manage change orders (ECOs) to release, correct and update any incorrect items
Support other projects as needed including internal training software and QMS driven changes.
Drive conformance of data quality standards across GUIDID, EUDAMED, GDSN, etc.


Skill/Job Requirements
Experience with GS1 standards preferred
2+ years of experience with Oracle Agile or similar PLM system
Bachelor's Degree or Associates degree with additional 2+ years of work experience required
Excellent attention to detail and love of keeping order of data elements is required
Previous experience in ECO workflows preferred
Ability to multi-task and work under tight timelines is required
Managing data attributes and single source of truth in a regulated environment for medical devices preferred.
Knowledge of global labeling systems preferred