Manufacturing Engineer II (Shift B M-F 2 pm - 10 pm)

General Summary

The mission of the Manufacturing Engineering group is to provide manufacturing technology and robust solutions that commercialize new products and support continuous improvement in production. This role focuses on hands-on process engineering in cleanroom environments, collaborating with cross-functional teams to resolve production floor issues and implement improvements. The position involves applying engineering techniques and judgment to optimize product quality, equipment performance, and manufacturing processes in compliance with GMP and ISO 13485 standards.

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering.
• 2+ years of engineering experience
• English Level: B2+ Advanced proficiency required for regular interaction with global teams and documentation in English.
• Detailed knowledge of GMP/ISO 13485 regulations and cleanroom environment practices.
• Experience with Lean manufacturing, Six Sigma, IQ/OQ/PQ, and FDA/ISO regulations.
• Competence using CAD software and MS Office (Excel, PowerPoint, Word).