Manufacturing Engineer
: Job Details :

Role: Manufacturing Engineer

Location: Irvine, California, United States

Key Responsibilities:

🔧 Process Development: Design, implement, and optimize manufacturing processes to improve efficiency, quality, and scalability for medical devices.

🔧 Validation & Documentation: Conduct process validations (IQ, OQ, PQ) and maintain compliance documentation aligned with FDA, ISO, and other regulatory standards.

🔧 Production Support: Troubleshoot and resolve production issues, collaborating with cross-functional teams to implement effective solutions.

🔧 Design for Manufacturability (DFM): Work with R&D teams to optimize product designs for manufacturability and scalability.

🔧 Continuous Improvement: Drive Lean Manufacturing and Six Sigma initiatives to enhance process efficiency.

🔧 Equipment & Tooling: Design, procure, and validate manufacturing equipment and tooling to support production.

Requirements:

🎓 Education: Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field.

💼 Experience: Minimum of 3+ years of experience in manufacturing engineering, preferably within the medical device industry.

🛠️ Skills:

• Hands-on experience with process validation and equipment qualification.
• Knowledge of FDA, ISO 13485, and other medical device industry standards.
• Proficiency in CAD (e.g., SolidWorks) and statistical analysis tools.
• Experience with Lean Manufacturing or Six Sigma methodologies is a plus.