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Engineer II in Round Lake, IL at Integrated Resources, Inc

Date Posted: 9/13/2018

Job Snapshot

Job Description

Engineer II

This role will be responsible for representing the global risk management process in leading Risk file generation for legacy Baxter products (disposable devices and/or drug products). The individual in the position will be required to facilitate the collaboration of information from medical, R&D, quality engineering and maintain compliance to the quality system in order to generate a risk management file. The incumbent will perform other duties assigned as required to support the larger risk management goals and initiatives.
1) Act independently with minimal supervision to conduct smaller approved projects. Expected to make suggestion on improvements based on recent technical knowledge.
2) Contribute to the planning and execution of components of the development process, which apply to product revision or enhancement or a defined piece of a larger project.
3) Ability to manage routine small projects without assistance.
4) Investigate and analyze customer complaint data and design documentation.
The individual must be proficient in working and generating documents in a GDP environment and a working knowledge of risk management (ISO 14971) or ability to quickly gain knowledge in this area.
1) Knowledge of the basic principles in various engineering disciplines.
2) Must have initial training in concepts of
¿Six Sigma
¿ quality techniques.
3) Must know how to effectively run projects, coordinate contractors, and direct the activities of a technician
Education / Experience
1) Bachelor of Science in either Engineering or Science
2) 1 - 3 years recent, related experience in a regulated environment.
3) Experience with GDPs and GMPs
4) Experience with Design History File (DHF).
3) Software: Excel (Pivot Tables, V-lookups, etc.)-required, PowerPoint, Outlook, Word, SharePoint
Nice to have Software: Trackwise 8, Minitab & DOORS
4) Previous compliant experience, nice to have

Interview platform: may vary, but right now 1.5 hours onsite interview 30 minute individual with the report to manager followed by an hour panel interview with other team members.