Senior Manufacturing Engineer ( ME )

Nevro   •  

Redwood City, CA

8 - 10 years

Posted 237 days ago

This job is no longer available.

Overview

This position plays a key role in supporting the manufacturing of a Class III implantable Neuromodulation system for pain management. This position reports to the Senior Director of Operations.

Role Requirements

• Supporting the manufacturing of Class III implantable Neuromodulation system components.
• Defining manufacturing processes and executing manufacturing activities including qualification and validation.
• Write, review and oversee verification and validation activities.
• Resolving technical issues encountered during manufacturing.
• Providing troubleshooting training to contract manufacturing engineers and technicians.
• Driving process improvements affecting yields, capacity increases, cycle time reductions and cost reduction initiatives.
• Oversee technology and process transfers.
• Participate in developing Process and Design FMEAs
• Initiate and review ECOs.
• Interfacing with other departments such as R&D, Regulatory, and Quality.
• Working in accordance with Quality System procedures and actively enforces its objectives.

Skills and Knowledge

  • B.S. Mechanical Engineering, or similar degree. Advanced degree (M.S.) is preferred.
  • A minimum of 8years of experience within the Medical Device industry, preferably manufacturing and/or designing implantable Leads and Implant Tools. 
  • Strong electro-mechanical design/manufacturing and analysis skills.
  • Experience with Solidworks.
  • Good analytical and problem solving skills.
  • Functional familiarity with the FDA Submission process, ISO Requirements and QSR requirements is also preferred.
  • Strong interpersonal and technical writing skills.
  • Experience managing contract manufacturers. 
  • Knowledge and experience using structured project management tools.
  • Requires the ability to travel approximately 20% of the time throughout the United States and internationally.

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2018-2146