The individual will contribute in the development of existing and new medical technologies and applications.
Duties and Responsibilities:
· Define and guide development of elegant mechanical designs that meet requirements for product performance, cost, reliability, and manufacturability.
· Develop designs for all phases of product development from proof-of-concept through manufacturing.
· Drive design verification by testing design performance in the lab and design validation by developing fast-turn clinical prototypes for use in the research clinic.
· Contribute regularly to technical design reviews, project scheduling, and development of new product concepts and applications.
· Use FEA simulation tools to model mechanical assemblies and guide design development.
· Other duties as assigned.
· B.S. in Mechanical engineering with 5+ years related mechanical design experience for capital equipment, laser, or medical devices. Graduate degree a plus.
· Experienced in design of opto-mechanical assemblies. Experience designing mechanical actuation assemblies such as laser beam scanning systems, translation and rotation stages is a plus. Knowledge of strain-free mounting techniques for optics using adhesives is a plus.
· Strong understanding of GD&T principles and ability to evaluate and apply them to precision mechanical designs.
· Proven 10+ years of CAD design experience. SolidWorks preferred.
· Extensive knowledge of leading manufacturing technologies including plastic injection molding, sheet metal manufacturing, and high precision machining.
· Proven communication skills and ability to make design recommendations based on cross-functional inputs (Engineering, Clinical, Manufacturing, Quality, and Regulatory).
· Ability to apply FEA simulation tools to develop designs by correlating simulation results with empirical test data.
· Basic working knowledge, electronics, optics, and numerical data analysis (Excel, Matlab, or equivalent). Data acquisition skills such as LabView is a plus.
· Familiarity with FDA Quality Systems Regulations/Design Control requirements and their application to projects from design inception to manufacturing release.
· Knowledge and experience with IEC 60601 compliance standards and ISO14971 Risk Management requirements and techniques.
|Job Category||Mechanical Engineering, Medical|