Sr. Mechanical Engineer

Huntington Beach, CA 92648

Employment Type: Direct Category: Mechanical Engineer Job Number: 8653

Job Description

Qualifications:

  • BS/MS Mechanical Engineering or Biomedical Engineering
  • 5 + years of experience in the medical device industry preferably in cardiovascular devices/implants, catheters
  • Experience using SolidWorks, Simulation
  • Strong familiarity of FDA regulations for medical devices ISO 13485, ISO 5840 (Cardiovascular implants)
  • Experience in medical device research and development, Delivery systems Design (catheters), familiar with design for extrusions, Nitinol fabrication (stents’...)
  • Experience medical device development up to and through clinical trials and 510K approval
  • Experience in developing test protocols, writing test reports
  • Strong interpersonal and communications skills

 

Responsibilities:

  • Design, prototype catheters for delivery of implantable devices
  • Ownership of design, development, and testing activities
  • Interpret safety, effectiveness results data, compile and analyze data from applicable sources
  • Drive schedule for feasibility testing activities, design verification testing, clinical release testing
  • Ensure product is optimized for DFM, qualify manufacturing and suppliers’ partners, work with manufacturers and suppliers to ensure smooth transition to manufacturing
  • Support transition and ramp up of manufacturing and assembly operations including qualification of tools, fixtures, processes
  • Support quality activities such as FMEA, V&V…etc.

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