Medical Device Manufacturing Engineer

San Jose, CA

Job ID: 127154 Industry: Med

 

Medical Device Manufacturing Engineer

Environment:
Our client is a leading provider of medical devices and software for the life sciences industry. They are in the midst of a facility shutdown and will be transferring to a new site.  

Project Scope &  Responsibilities:

Our client is a large Medical Device manufacturer of a number of Class II and III medical devices. They will be responsible for the technical issues related to maintaining current production line and maintaining regulatory compliance. They will be part of a team that is moving operations to a new facility. They will create, modify and train on manufacturing assembly or test methods and associated forms. They will prepare documents necessary to complete Engineering Change Orders. They need be comfortable enough supporting Master Validation Plan for relocation. They will be working with Quality Engineering to write Validation Protocols – Equipment IQ and OQ as well as direct execution and/or execute Validation protocols and write Reports. They should have experience solving mechanical and /or software issues from production floor, working closely with electrical engineering, technicians, assemblers, quality engineering, software engineering and Development Engineering. This individual will be working with suppliers and quality engineering on nonconforming material, Analysis of Non-Conforming Material for root cause and corrective actions. Having experience with electromechanical products would be a huge plus. They are looking for someone with a casual attitude that “ can do, will do”. This consultant should have at least 7 years’ experience and must be comfortable in a fast paced environment hit the ground running.

Required:
  • Medical Device Experience 10 years
  • Manufacturing 7+ years
  • Facility Transfer

Desired:
  • Electromechanical products

  Job Type: Contract 

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