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    R&D Engineer - Irvine, United States - Katalyst HealthCares & Life Sciences

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    Description
    Responsibilities:
    • The R&D Engineer conceives and implements Client testing approaches to answer test engineering questions.
    • He/she investigates, identifies, develops, and optimizes new test methods and techniques, as a critical contributor to feasibility, development, and verification stages of product development through creation and release of design verification plans, protocols, records and reports, while developing productive collaborations and communications with other groups across engineering disciplines.
    • Routinely demonstrate engineering initiative and creativity in the CPD research and development activities.
    • Highly autonomous and productive in performing experimental research or test method development, requiring only minimal direction from or interaction with supervisor.
    • Formulate conclusions and design follow-on tests as needed based on multidisciplinary data.
    • May propose and initiate new areas of investigation that are engineeringly meaningful, reliable, and can be incorporated directly into a CPD research and development program.
    • Be a primary author of publications, presentations, regulatory documents and/or primary inventor of patents.
    • Demonstrates high proficiency across a wide range of relevant technologies, in his/her projects as well as the overall program, while maintaining a high level of productivity in the lab.
    • Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, GxP compliance, and animal care where applicable.
    • Direct mentorship of other junior engineers.
    Requirements:
    • A degree in an engineering field (mechanical, materials, chemical, bioengineering): BS or equivalent education and extensive, typically 10+ years of experience; MS or equivalent education with typically 6+ years ofbexperience; PhD or equivalent education with 2 years of experience.
    • Possess thorough theoretical and practical knowledge to carry out lab testing and other lab-based activities.
    • General understanding of the safety requirements for the lab-based activities.
    • Adept experience with tooling and test fixture design.
    • Experience with work in the regulated environment desired, developing test tools and test methods conforming to industry standards.
    • Demonstrated experience of good documentation practice (GDP) and good laboratory practice (GLP) essential.
    • V&V testing experience
    • Test method development/validation
    • Good communication skills, both written and oral.
    • Ability to develop and execute design verification and validation plans, protocols, data processing, and test reports.
    • Proficiency in MS Office, Minitab, Visio, MATLAB, LabView.
    • Fixture design CAD/SolidWorks, execution, test.
    • A team attitude with positive outlook is a must.
    • Test Method Validation
    • Test method development
    • Test Fixture design

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