Reliability Engineer


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

Job Description:
This position will be responsible for supporting parenteral/injectable medical device / combination product development being performed with external development partners and suppliers.
Supporting technical staff and the contract medical device manufacturers and technical consultants for the development of drug delivery devices and related components.
Developing appropriate system-level requirements, specifications, test methods and technical protocols and reports in support of combination product development activities as required to support the Design History File (DHF).
Establishing engineering laboratory capabilities for device functional testing, characterization and measurement method development.
Generating Design and User FMEAs.
Developing and executing both system and component level test plans to identify design robustness and potential weaknesses.
Assessing component manufacturing process capability.
Evaluating the impact of component tolerances on design performance and reliability.
Evaluating device subassembly and final assembly processes using parenteral sterile product manufacturing experience.
Managing multiple project plans to ensure that deadlines are met on time and on budget.

Experience in medical devices, preferably in PR&D, Manufacturing or Quality.
Experience with medical device design and development, mechanical systems integration and testing.
Some measurement method development experience.
The ability to effectively communicate, both written and verbal, with all levels of the organization and with development and manufacturing partners and suppliers.
Basic understanding of medical device regulations (QSR 820 and cGMP Parts 210 / 211) and applicable guidance.
Strong project management and leadership skills.

If you are interested in hearing more about the position please respond to this posting with your resume attached.

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