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Senior Design Quailty Engineer, Medical Device

Location: Billerica, Massachusetts, United States
Reference ID:

Our client is an incredible start-up that has a very disruptive technology that decreases an industry challenge with blood clotting by 98%.  They are in a new growth phase with significant new product development in their pipeline and we are supporting the Head of Quality for multiple opportunities including a Design Quality or Senior Design Quality Engineer opportunity that will help support NPD/NPI for design controls, inputs/outputs, the DHF, risk assessment and management, TMV, and technology transfer.  Our client has had 5 new 510 (k) submissions approved by the FDA and there is exciting growth on the horizon.  Every new hire comes in with stock/equity, as well.

The Right Talent:

BS in Engineering or relevant field 

3+ Years of Medical Device, Pharma, or Biotech Design Quality Experience 

Experience with Design Control inputs/outputs, DHF, FMEA, Design V&V, Risk Management, & ISO 14971

Project Management skills preferred

Experience with statistical analysis and Minitab

Works well in start-up environment 

 

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