Mechanical Design Engineer

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Mechanical Design Engineer

Mechanical Engineering
  • Location: Clearwater, Florida
  • Type: Direct
  • Job #1909

The Single-Use Disposables Engineer (mechanical design engineer) will be focused on single-use design products for machines that they manufacture. Single-use design, Soildworks 3D design and Single-use workflow for disposables. Single-use components are assembled in different facilities throughout the United States and shipped worldwide to be put in service with the required regulatory compliance built in the design.

This person will travel to vendor sites to validate product designs.  The position requires the understanding of Life Sciences for cell culture harvest, centrate clarification, cell therapy, human and animal vaccine, harvesting of CHO and Stem cells.

REQUIRED EXPERIENCE & SKILLS:
5+ years of experience with pharmaceutical or biopharma EQUIPMENT VALIDATION
5+ years of experience designing with Solidworks
Experience with pharmaceutical single use development
Experience with RF and Ultrasonic welding used to join thermoformed plastic
Experience with plastics manufacturing
Experience with FMEA analysis
Experience with ISO13485/ ISO 9001 standards for clean rooms
Project engineer or project management experience
Ok with up to 30% travel
BS in Engineering (BSME preferred)

DESIRED EXPERIENCE & SKILLS:
Experience in selection of tubing, tubing connectors and tube set filter’s
Experience Class VI Clean Room environment
Experience with gamma irradiated guidelines for sterilization
Experience with particle elimination and imbedded particles according to Tappi Charts

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