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

R&D Engineer III

Kasmo Global • Irvine, CA, United States

30+ days ago

Job type

Full-time

Job description

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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