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Engineer II
Engineer II
Department: Quality (Risk Management)
Summary
This role will be responsible for representing the global risk management process in leading Risk file generation for legacy 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.
Responsibilities
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.
Qualifications
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
Bachelor of Science in Mechanical Engineer
Experience with GDPs and GMPs
Experience with Design History File (DHF), strongly preferred.
Previous project coordination/management experience strongly preferred. Even candidates that have project engineering degrees and experience highly desirable.
Software: Excel (Pivot Tables, V-lookups, etc.)-required, PowerPoint, Outlook, Word, SharePoint
Nice to have Software: Trackwise 8, Minitab & DOORS
Previous compliant experience, nice to have
Soft skills: adaptable, resourceful, ability to follow up and knowledge of when to escalate.