Þveloper

Knowledgeable in ISO 13485 Medical Device Quality Management System Requirements. Knowledgeable in ISO 14971. Experience with Systems Architecture Design, Technology Development, and Systems Integration with Microfluidic or Flow-cytometry Instruments is Highly Desirable. Knowledge of manufacturing and process development activities such as qualification, validation, design of experiments (DOE), and FMEA. Working Knowledge of Statistics, DOE, DFSS, and/or Signal Processing Algorithm Optimization is Desirable. General Knowledge or Experience with Molecular Biology, Immunology, or Biological Sciences is Desirable. Extensive Hands-on Experience with Pumps, Valves, Sensors, Feedback controls, and Firmware for Microfluidic Applications is Required. Applies system engineering principles to develop cost-effective, reliable, high-quality systems that satisfy customer needs and drive business strategies. Establish master design verification & validation plan for a product in development. verification & Validation of development protocols