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Engineer

My name is Savina and I represent The Fountain Group. We are a national staffing firm and are currently seeking a Engineer prominent client of ours. This position is located in North Chicago, IL. for the position are as follows:

Job Description:
Seeking a Medical Device Engineer to be responsible for the development of formulation and analytical development of new products.

Responsibilities:
Knowledge and experience in medical device Design Controls is a must(ISO 13485, 21 CFR 820)
Basic understanding/knowledge of industry standards (ISO, IEC, etc.) medical devices
Scientific memos and/or other form of documents required for the design and development of the infusion pump accessories, e.g. draft and share with team; verification plans, protocols, verification and validation records/reports
Technical writing for authoring design control DHF documents in general. Includes: User needs, Product Requirements, Risk Management documentation, Tracematrix, Verification records/reports.
Demonstrate in lab testing and develop/modify the protocols for typical device and drug-device combination product tests, e.g. force testing of components, environmental testing, etc.
Develop project plans and execute against strategy, maintain timeline for projects and tasks
Must be very driven and work independently and with cross-functional teams(QA, RA, Manufacturing)
Work directly with manager to lead the design and development efforts of a medical device by managing key sub-projects within development scope: e.g. participate as one of the core team members, work with internal cross functional team members and with external design verification firms, assist in design development documentation and reviews to achieve program milestones.
If interested in the role above, please respond to this email with your resume attached.


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