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 descriptionB.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.
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 :
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