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Mechanical Engineer
Ref No.: 18-66945
Location: Irvine, California
Position Type:Full Time/Contract
Experience Level: 7 Years
Start Date: 09/12/2018
Technical/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.
Experience Required
  • Ability in CFD modelling of multiphase systems
    Assist in developing product concepts, specifications, drawings
    Review invention submissions, work with patent attorneys to assess their patentability, and other patent related activities, including IP landscape search, freedom to operate search, patentability search, and prosecution of patent applications.

  • Ability to derive product requirements from customer needs, apply critical thinking and lead the process of identifying the few critical requirements
  • Must have experience in the medical devices industry as well as a basic understanding of the regulatory requirements
  • Must have experience in Engineering Documentation for medical devices (Product Design & Development Documents, Protocols, Test Reports, MEMOs and Rationales for Engineering Activities)
  • Good knowledge in design program/project approach and governance
  • Knowledge of change management and communication plans
  • Preferred to have experience with design, engineering and functioning of  surgical devices
  • Experience in CAD tools (like Unigraphics NX/ Solidworks), Component and Assembly Drawings, Engineering Analysis Reports,
  • Experience in GD&T and Tolerance Analysis
  • Experience writing Functional Requirements, Design Specifications and Risk Management Documents
  • Should have basic Knowledge of Plastic and Metal manufacturing processes
  • Experience working with medical device regulations
Roles & Responsibilities
  • Participate in development projects core teams as the R&D representative and technical lead
  • Ability and discipline to adhere to schedules and tasks based on instructions/guidance from engineering leadership.
  • Ability to maintain & operate equipment, such as 3D printers, and CNC machine
Design Engineering activities for Product Sustenance teams and New Product Development Teams
  • Creation of Engineering Documents
  • Execution of Device Verification Tests and creating of related documentation
  • Liaison with offshore counterparts and cross-functional teams
  • Creation of Requirements Management Documents
  • Design and develop new products for customer's product roadmap; the role of the Product Design Engineer ranges from early concept exploration to implementation of the final product for mass production
  • Develop 3D CAD, engineering drawings, and specifications as part of the product development process, for prototypes and final products
  • Develop and implement plans for research, design for manufacturing, design validation, qualification, etc. in partnership with Program Management, R&D team members, Quality, Consumer Insights
  • Documentation and communication of design history, engineering change orders, etc. to multifunctional team and third party suppliers
  • R&D support for manufacturing and operations as needed.
  • Overall responsibility to his/her Manager for the attainment of technical goals agreed in relation to project objectives with the appropriate level of guidance and within agreed deadlines
  • Participation in and facilitation of face-to-face events with customers and stakeholders