Mechanical Engineer - Principal R&D Engineer

Pleasanton, CA 94588 | Direct

Job ID: 7986 Category: Mechanical Engineer

Qualifications:

  • BSME, or equivalent hands-on experience
  • Over 12 years experience in medical device development 
  • Solidworks 3D Modeling
  • Hands-on design, protoyping experience
  • Experienced in all product development stages - design,prototyping, implementation, verification, validation, and manufacturing scale-up
  • Demonstrated success taking devices/products to market
  • Familiar with FDA, ISO 13485, MDD reguations

Responsibilities:

  • New product development and improving current products 
  • Prototyping and testing, V&V
  • Create and share Design Reviews with the team
  • Investigate root cause of product failures and create design solutions
  • Initiate action based on CAPA under FDA 21 CFR 820
  • Support manufacturing team in new and sustaining manufacturing process
  • Help in create plans, budgets, schedules for new product development
  •  
high volume, mechanical systems, ISO 13485, FDA, protyping, design of experiment, root cause, analysis, validation, verification, SolidWorks

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