Senior Mechanical Engineer

Brisbane, CA

Posted: 04/22/2019 Employment Type: Direct Hire Industry: IT Job Number: JOS000008611

Position Summary: 

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 company 
  • 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. 

Position Requirements: 

  • 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. 

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