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Mechanical Engineer
Ref No.: 18-66929
Location: Irvine, California
Position Type:Full Time/Contract
Start Date: 09/12/2018
Mechanical Engineer
Irvine, CA
Fulltime Permanent


Required Skills:
1. Must hold bachelors or Masters degree in Mechanical Engineering
2. Knowledge in Solidworks, 3D and 2D
3. Exp working in cost reduction projects
4. Must have exp working in medical device industry
5. Exp in 3D printing, prototyping, visibility study, working with suppliers, validation and verification.

Technical and Functional Skills:
The R&D Engineer is responsible for designing devices using SolidWorks, prototyping by hand and instructing technicians on device assembly, as well as performing
bench testing as needed.
Ability to build prototypes, including device assembly
Understanding of Engineering principles, Product designs, Design Specifications, Product Requirements and Product mechanisms
Understanding of Medical Devices and related Regulatory Standards
Understanding and experience of Design, Development, Verification and Validation activities and creating related documents for medical devices
Engineering documentation for new product development and sustenance engineering activities for medical devices
Execution of Product Design Verification Testing Activities and creation of Test Protocols and Reports
Execution of Risk Management Activities (Design FMEAs, Application FMEAs, Process FMEAs, Fault Tree Analysis etc.) as per ISO14971 (Medical Device Standards)
Concept Design for medical devices/Instruments
3D CAD modeling and drafting in NX/ Solid works
Assign and interpret GD&T controls in Drawings
Understanding of product requirements management framework
Design change identification based on interpretation of engineering analysis (Tolerance Stack-up, force analysis, Mold Flow simulations, FE Analysis) results
Understanding of Manufacturing and Assembly processes
Perform Tolerance Analysis and Force Analysis
Coordinate with customers and mfg. vendors for design finalization
Value analysis of components/ products
Prepares detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols.
Design test fixtures for performing Design Verification & Validation tests.