Description
This new technical lead will work in the Global Device R&D organization and will provide new concept generation, product development and engineering expertise in complex electro-mechanical medical devices. A strong background in mechanical component design, system architecture, theoretical analysis, CAD, feasibility testing, manufacturing processes.Responsibilities:
- Propose and develop design concepts and solutions through 3D CAD modeling, theoretical analysis, prototyping and feasibility testing.
- Prepare and conduct technical reviews and design reviews for cross-functional team approval.
- Write test protocols, build test set-ups, manage testing activities and write test reports.
- Maintain compliance to current good manufacturing practices (cGMP) and Quality System Requirements.
- Submit documentation as required into Product Lifecycle Management (PLM) systems and Design History File (DHF).
- Apply state-of-the-art understanding of relevant engineering principles in areas such as drug delivery and drug packaging and plastics design.
- Develop new design / product concepts to increase the company's intellectual property portfolio
Experience:
- Must possess strong technical leadership skills with 10+ years of continuous engineering experience and proven expertise in designing and deploy high-tech products.
- High proficiency with SolidWorks 3D modeling, 2D drawing and Geometric Dimensioning and Tolerancing (GD&T).
- Capable of interpreting and performing tolerance stack up analysis for complex sub-assemblies.
- Familiarity in injection molded plastic, machined and sheet component /assembly design for manufacturability.
- Familiarity with current good manufacturing practices (cGMP) and knowledge of medical device quality systems are highly recommended.
- Experience in electro-mechanical medical device design is a plus.
- Team oriented attitude, excellent verbal and written communication skills are essential.
Qualifications:
- BS degree in Mechanical Engineering is required.
- 10+ years of engineering experience
To find out more about Real please visit www.realstaffing.com