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R&D Engineer III
R&D Engineer IIIKasmo Global • Irvine, CA, United States
R&D Engineer III

R&D Engineer III

Kasmo Global • Irvine, CA, United States
Hace más de 30 días
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

R&D Engineer III

Location : Irvine, CA

Employment Type : Contract / Onsite

Job Duties :

  • Design and development of combination products and medical devices, ensuring compliance with industry standards and regulations.
  • Apply knowledge of system engineering, risk management, and usability engineering throughout the product lifecycle.
  • Perform design work using 3D CAD, 2D drawings, and Finite Element Analysis (FEA) tools.
  • Conduct and document design verification and validation testing, including test method development.
  • Implement and maintain design control processes , including risk analysis, design input / output, and design reviews.

Required Skills :

  • B.S + 5 years or M.S + 3 years direct experience in Pharma, BioPharm, or medical devices.
  • 3+ years of Design control experience is required.
  • Experience in SolidWorks, FEA, Fixture Development, Test Method Development, Test method Validation (must).
  • Hands-on experience in design and development of medical devices and combination products.
  • Solid understanding of design controls (end-to-end), system engineering, risk management, usability engineering, and global regulatory requirements.
  • Exposure to high-volume manufacturing, device packaging (including biologics), and materials such as plastic (injection molding), glass, rubber, and hypodermic syringes.
  • Proficient in 3D / 2D CAD, FEA analysis, and related engineering tools.
  • Strong background in test method development, protocol creation, and report documentation.
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