Manufacturing Engineer

5 days ago


Plymouth, United States Intellectt Inc Full time

Role: Manufacturing Engineer

Location: Plymouth, Minnesota, US


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.


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