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Engineer II, Research & Development

Orange County Metro Area, CA

Posted: 05/28/2019 Job Type: Engineering Job Number: JN -052019-24962
Engineer II, Research & Development
Life Sciences Industry
Irvine, CA

Description

The Engineer II, Research & Development will support the Critical Care Mechanical team working on new product designs, technology development and sustaining of core product lines with an emphasis on hands on new product development.

Key responsibilities:
  • Support the development of critical care devices or subsystems thereof from concept to commercial launch
  • Apply engineering principles to the design of electro mechanical medical devices, effectively use tests and simulations to expedite development in a fast paced environment
  • Design, prototype and test components of medical devices, develop new test methods to evaluate devices
  • Work with internal and external resources to contribute to the design and development, testing and release of electromechanical components used in medical device systems
  • Solve technical issues working as a contributing member of a diverse engineering team
  • Integrate development of medical technology by assuring the design of technology interfaces and system elements works together as a whole
  • Write design verification and validation protocols and reports in accordance with quality procedures assuming full ownership as the Study Director
  • Provide solutions to the technical aspects of product design and development as well as the translation of marketing requirements into product specifications
  • Work with R&D technical teams (Mechanical, Electrical, Systems, Software) and internal partners in the Marketing, Regulatory, Quality, Clinical, Manufacturing and other departments to deliver project objectives
Qualifications
Required:
  • Bachelor s Degree in Mechanical Engineering with a minimum of two (2) years experience (Master s or PhD degree lessens the experience required for the position)
  • Must have good 3D CAD skills in SolidWorks
  • Must have demonstrated the ability to solve engineering problems, through testing, analysis, simulation (FEA, CFD) modeling etc.
  • Working knowledge of basic statistics and six-sigma principles
  • Requires strong technical aptitude, leadership, communication, writing and coordination skills
  • Requires a high-energy individual who has excellent teamwork, partnering, and negotiation skills
  • Must be a highly motivated self-starter who is able to achieve results with minimal direction
  • Must be proactive and creative in achieving goals
  • Must have strong conflict resolution skills
Preferred:
  • Previous mechanical design experience with disposable devices, capital equipment, and/or sensors (pressure, flow, optical).
  • Proficiency in mechanical design, tolerance stack-up analysis, design for Manufacturability (DFM), and specification development
  • Experience in design verification & validation within an FDA regulated industry
  • Experience with design control procedures
  • Experience with Solidworks, LabView, MatLab, and quantitative analysis of data
  • Knowledge of relevant manufacturing processes like injection molding, extrusion etc.
  • Comfortable in a dynamic working environment with multiple priorities
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