R&D Engineer III

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.