SolidWorks Engineer

SolidWorks Engineer

Direct Hire. 105-120k

Buena, NJ

Talentry is looking for an experienced SolidWorks Design Engineer who can help design rigid plastic packaging for medical device products. The right engineer will develop products through CAD designs. He or she will ensure clear written design histories, risk evaluations, V&V, testing protocols, drawings, specifications, and other appropriate engineering design documentation in support of a high-quality compliant device that conforms to FDA, ISO, GMP, and other appropriate standards.

This engineer will use his or her design experience in the mechanical or electromechanical medical device field to develop strong 3-D designs developed with manufacturability and FEA in mind. He or she will create prototypes, define appropriate outputs, perform FEA and Mold Flow Analyses, etc.

Requirements

BS in Mechanical Engineering, or similar engineering field and 5+ years of experience.

4+ years of mechanical / electromechanical design experience in an FDA regulated GMP environment.

Plastics design experience is a firm requirement.

Experience with 21CFR820 and ISO 13485 requirements.

Proven SolidWorks expertise.

ERP and PDM system experience.

Strong communication and documentation experience.