Overview
The Product Development Engineer is part of a cross-functional engineering team driving the design, development, verification, and manufacturing transfer of novel interventional medical devices. The individual reports to the Director of Product Development.
Responsibilities
�Summary and refinement of product specifications �Brainstorming of innovative device design concepts �CAD design of device concepts �Prototyping and evaluation of design concepts �Engineering design analysis, including tolerance analysis �Development and maintenance of drawing packages �In-vitro test method development and fixture design/fabrication �In-vivo and in-vitro study protocol development, execution, reporting �Development of manufacturing processes and documentation �Creation and maintenance of design controls documentation �Generation of product risk analyses �Initiation of document change orders, purchase orders or other business processes in support of product development activities �Fostering of client relationships and provision of responsive service in a contract environment �Adherence to Quality Management System procedures/design controls
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