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

<h3>General Summary</h3>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<strong>hands-on process engineering</strong>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<strong>GMP and ISO 13485 standards.</strong>
<h3>Qualifications</h3><li>Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering.</li><li>2+ years of engineering experience</li><li>English Level: B2+ Advanced proficiency required for regular interaction with global teams and documentation in English.</li><li>Detailed knowledge of GMP/ISO 13485 regulations and cleanroom environment practices.</li><li>Experience with Lean manufacturing, Six Sigma, IQ/OQ/PQ, and FDA/ISO regulations.</li><li>Competence using CAD software and MS Office (Excel, PowerPoint, Word).</li>