Recruitment | Chicago Recruiters | Process Engineer | Medical Devices

Kappa Search Inc. is a Chicago recruiter that specializes in engineering, manufacturing, supply chain and technical sales recruitment and placement.

Our client, a leading medical device manufacturer, is seeking a Process Engineer to support new technology, new devices product development, and the manufacturing of products. This is a hands-on position. The person will work in conjunction with manufacturing and development teams and with other technical associates.

* designing, building and testing prototypes
* performing and writing validations of product, processes and equipment in accordance with FDA and ISO guidelines
* designing, executing, and analyzing experiments based on statistical techniques
* develop, troubleshooting and refining medical device manufacturing processes and equipment
* conceptualizing and instituting improvements to a medical product and its manufacturability
* evaluating proposed improvements to processes and products based on analysis of regulatory requirements, product quality needs, ergonomics, safety, environmental and economics
* driving the efficient scale-up of manufacturing processes
* developing and carrying out performance tests on a device to characterize and document its safety
* documenting work via reports, technology notebooks, and design file entries

Critical success factors are:

* a work style of hands-on involvement with all phases of his/her projects
* a demonstrated ability to prioritize, initiate, and drive projects to completion
* solid knowledge of engineering fundamentals and ability to apply this knowledge to manufacturing and product design
* knowledge of the fundamentals of statistics
* ability to work effectively in team situations as well as independently
* demonstrated excellent communication skills, both written and oral
* ability to network and interface effectively with a broad range of associates spanning varied disciplines and responsibilities
* working understanding of GMP, ISO 9000 and ICH requirements