"MUST have recent electrode lead design experience"

The position is based in Santa Clarita, CA (Valencia) = REMOTE IS NOT AN OPTION!

Primary Function:

• Research, design, and develop mechanical implantable devices, which meet performance, cost, and manufacturing goals.
• Design prototype tooling for proof-of-concept process development. Perform testing of designs to demonstrate performance and regulatory compliance.
• Transfer designs and processes to manufacturing.

Duties and Responsibilities: 

• Mechanical design and material selection for neurostimulation devices and surgical tools.
• Detailed mechanical engineering design, cost estimation, design reviews, risk analysis, hazard analysis, FMEA-Design/Process/Use, tolerance analysis, material analysis, force analysis, stress analysis, thermal analysis, dynamic analysis, molding analysis, and design verification testing.
• Mechanical and electromechanical modeling of devices when appropriate.
• Design of prototype tooling for proof of concept and process development.
• Proper design and process documentation required.

Knowledge and Skills:

• SolidWorks 3D CAD or Pro Engineer Creo & ANSI Y14.5 experience
• Strong materials and mechanical background
• Excellent Communication Skills (Written and Oral)
• Documentation Skills (Specifications, Test Plan, Test Report, FMEA, etc.)
• Experience with biomedical devices and/or specific knowledge relating to implantable & hermetically sealed biocompatible devices is preferred.
• The following are considered a plus:
  - Finite element modeling (Ansys)
  - Knowledge of micromachining techniques and injection molding
  - Knowledge of QSR, GMP, and Relevant Medical Standards
  - Experience with submission to regulatory bodies
  - Statistical process control, and experience with design for manufacturing

Education and Experience:

• Master or bachelor degree in mechanical engineering or equivalent.
• Min. 3-5 years of professional experience, with a combination of product development and manufacturing.

• Desirable industry background includes medical device, electromechanical systems or consumer electronics.
• Demonstrated execution of all phases of product development.