Stefanini Group is hiring!
Stefanini is looking for Engineer I at Round Lake, IL Location
For quick Apply, please reach out to Jaykiprasad Gupta - call: 248-728-2636/ email: jaykiprasad.gupta@stefanini.com
- Position will be responsible for developing and executing verification and validation protocols related to Renal therapy.
- Experience in translating product requirements into test / use cases, essential. The position will be responsible for a portion of a fluid handling system.
- Responsibilities include design and development of precision plastic devices and components, developing test plans for functional testing, biocompatibility testing of materials and qualification of sterile packaging.
- As the primary job function of this position is in the design arena, the Engineer will manage /update the Design History File (DHF), direct experimental design, author protocol development and technical reports when needed.
- This position will report progress weekly to a management team and will require excellent communication skills to work globally and cross functionally.
- In this role the engineer will manage routine small projects without assistance, recommending design improvements as needed.
Qualifications:
- Technical writing, solid modeling, statistical analysis, cross functional communication, experimental design, and verification and validation of requirements and user needs.
- Experience working in a Design Control governed environment is desirable.
- Knowledge should include experience with device Design History File structure, Risk Management documentation and Product Requirements management, statistics and Test Method Validation.
- Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- Knowledge of the basic principles in various engineering disciplines.
- Must have initial training in concepts of 'Six Sigma' quality techniques.
- Must know how to effectively run projects, coordinate contractors, and direct the activities of a technician
- BS in Mechanical/ Biomedical/ Chemical Engineering.
- 2-5 years Medical Device experience.
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