Sr. Verification and Validation Engineer - 14000005RZ

Organization
Abbott Molecular
Job Location
Des Plaines, IL (Chicagoland),
Salary
Benefits
Job Description

As part of an R&D team, the Sr. Verification and Validation (V&V) Engineer will be responsible for leading the verification and validation activities for a new product system according to FDA requirements and internal quality standards. This role will support the Systems Engineering group and activities includes generating V&V protocols and reports, performing testing, data analysis, and participates in troubleshooting issues throughout the product development cycle. In addition, it is expected this role will support the traceability of the V&V results to the design input and output elements, document and maintain system configuration, and ensure that all test equipment are appropriately validated and controlled. This position will ensure that the project progresses as planned, and meets the project’s goals and deliverable per Abbott quality system. This position will work with a multidisciplinary team and external vendors to resolve V&V issues, engage in troubleshooting, and contribute to project development activities.

Essential Duties and Responsibilities:
•Primary lead for the V&V activities, and coordinate activities with other V&V members
•Define and develop V&V protocols based on design inputs.
•Perform testing, analyze results, resolve deviations, and generate V&V reports.
•Maintain and control configuration of systems and validated test equipment.
•Monitor progress via V&V plan, project schedule, and work with cross functional team.
•Supporting role for systems engineering, and requirements engineering activities.

Requirements

Minimal Qualifications
•BS Degree in technical discipline
•3+ years experience in V&V activities, including hands-on protocol, testing, and report generation in regulated industry
•3+ years experience in GLP environment, and lab safety practices
•Must be willing to work in biohazard lab with internal and clinical samples.
•Knowledge of FDA, and ISO standards.
•Work with cross functional team including HW, SW, Science, and external vendors.
•Strong organizational, documentation, and communication skills
Additional Desired experience:
•5+ years experience development of medical device, diagnostics related systems
•1+ complete product development cycle with V&V engineering experience in medical industry.
•Practical and working experience with GLP, FDA, ISO, and medical industry standards
•Working experience in BSL 2 or greater environment.
•IBM DOORS experience.

How to Apply

If you are interested in being considered for this opportunity, please visit our career page at: www.abbott.com. You can immediately apply using the following link: https://abbott.taleo.net/careersection/2/jobdetail.ftl?lang=en&job=14000...

To learn more about other opportunities at Abbott, visit the Abbott Facebook Careers page and access via the "Work for Us" link.

About Our Organization

Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 69,000 people.

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