R&D Engineer

This is an initial year-long contract with the intention to convert to a permanent role after the contract period.

My client is leading in their field and is looking to build out it's world class Research and Development team. The R&D engineer will play an integral part in bringing new products to market. The role will include designing and analyzing intravascular medical devices, developing design/process characterization, praparing experimental and per-clinical plans/timelines, writing testing plans/protocols/reports and transferring designs and processes to manufacturing engineer at product launch.

Duties and Responsibilities:

* Design and analyze intravascular medical devices or medical device components.
* Develop and execute design/process characterization, verification, and validation plans, protocols, and reports.
* Help prepare experimental and per-clinical plans and timelines, execute plans/experiments, and report progress to plan to core engineering team.
* Create and rationalize product and anatomical test method design specifications
* Understand, use, and complete engineering drawings with specifications and tolerances
* Write testing plans, protocols and reports
* Effectively transfer designs and processes to manufacturing engineering at product launch
* Work effectively in a cross-functional collaborative team environment
* Perform job functions in accordance with applicable GMP and ISO standards
* Comply with applicable FDA and International Regulatory laws/standards and the Code of Conduct

Qualifications:

* Bachelor's degree in Chemical, Materials, Biomedical Engineering, or related technical field; Graduate degree in a technical discipline preferred
* 3 - 5 years of applicable work experience in an engineering role
* Proficient in Design FMECA/Process FMECA
* Application of statistical and analytical methods such as SPC, SQC, and DOE
* Test method development, protocols, execution, and report writing
* Process background (development, capability, optimization, validation) within a regulated industry and/or design development experience.
* Experience with vascular catheter products, processing and technologies preferred
* Combination Medical Device Experience preferred
* Pre-clinical and anatomical in-vivo/in-vitro method development experience desired
* Project management associated with new product development and the successful transfer into manufacturing
* Good verbal and written communication skills

Apply now for immediate consideration or contact Colleen Kalland on 312.453.9088. If your profile is not a fit for this position, but you are interested in similar opportunities please apply and I will be in contact.
To find out more about Real please visit www.realstaffing.com