Engineer - Degreed IV - 28568

The primary responsibility is in mechanical/device engineering and drug delivery with the focus on design functions for continuous improvement of drug/device combination product line. The design shoul have hands on experience in PRO-E or Solidworks. Support biotech/ biopharmaceutical products with the skills for drug delivery in device design / tool design / molding, development and manufacturing for high volume productions utilizing GPM and ISO standards. Experience in partnering with third party manufacturing for production MAJOR RESPONSIBILITY: * Responsible for mechanical /design in medical device 3-D design with focus on CAD/CAM system such as PRO-E or Solidworks, for device parts design and tool/mold design for high volume injection molded plastics production of components and assemblies * Responsible for geometric dimensioning and tolerancing (GD&T) of device part and tool/mold and design system stackup analysis * Responsible for MoldFlow (fill, pack, cool, warp, gate and vent) analysis for mold/tool design and their simulation to determine the manufacturability of device parts*Experience in system integration of design, materials, process, equipment and assembly for medical device and experience in device functionality testing of components and subassemblies * Experience in verifying and testing functional prototypes and verifying specs for commercial production * Experience in design FMEA analysis for combination drug/device, user FMEA analysis and process FMEA analysis of disposable medical devices

• Mechanical, chemical, materials/polymer engineering or engineering science with 7-12 years of experience in combination drug/device products and medical device field * Knowledge in drug delivery system for proteins based biotech drugs to meet product functionality, manufacturing reliability and user friendly applications. * Involved in continuous improvement of drug-in-device systems and their modifications to improve quality and reduce cost * Capable of determining critical factors of drug dosage delivery compliance via device and prefilled syringes.