Description
Primary responsibility:The primary responsibility is in mechanical/design engineering and drug delivery for existing and new and pipeline device delivery for device-drug combination products. Support biopharmaceutical products with the skills for drug delivery in device design / design modeling / materials / tooling / molding / lab testing, development and manufacturing for high volume productions utilizing GMP and ISO standards. Experience in partnering with third party manufacturing for production is preferred.
Major Responsibilities:
* Responsible for medical device 3-D design with focus on CAD/CAM system for device parts design and tool/mold design for high volume injection molded plastics components and their assemblies
* Responsible for geometric dimensioning and tolerancing (GD&T) of device part and tool/mold and design system stack-up analysis
- Responsible to conduct product component and assembly design and using Pro/E, Pro/Mechanica, Pro/Surface CD tools for product design, development, analysis and improvement
Skills Requirement
- Experience in device design (Pro-E, Solidworks) by using scientific approach to conduct part design, subassembly design and system design integration for combination product
- Experience in polymeric materials for medical device design and molding process for disposable medical products for device-drug delivery systems
- Experience in system integration of design, materials, process, equipment and assembly for medical device and experience in device functionality testing of components and assembly
- Experience in design FMEA analysis for combination drug/device, user FMEA analysis and process FMEA analysis of disposable medical devices
- Experience in electromechanical fields for medical device design and assembly and qualification in system integration experiences.
- Mechanical, manufacturing, chemical, materials/polymer engineering or engineering science with 5+ years of experience in combination drug/device products and medical device field
To find out more about Real please visit www.realstaffing.com