Manufacturing Engineer - Intellectt INC

Job Description:

We are looking for a Manufacturing Engineer to improve our processes for surgical products in the medical device industry. The ideal candidate will have experience with installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), strong SolidWorks skills, and knowledge of medical device regulations and cleanroom practices.

Key Responsibilities:

• Work with teams in Quality Assurance, Purchasing, and Manufacturing to enhance production processes.
• Design and procure manufacturing tools and equipment.
• Implement and validate new manufacturing processes and equipment.
• Assist with material selection and validation.
• Write and update manufacturing procedures and instructions.
• Create and maintain Bills of Materials (BOMs) and Device Master Records (DMRs).
• Resolve manufacturing issues and improve processes.
• Support quality investigations and improvements.
• Suggest new manufacturing technologies and practices.

Qualifications:

• Bachelor's degree in Mechanical, Manufacturing, Materials, or Biomedical Engineering.
• At least 6 years of engineering experience, preferably in the medical device field.
• Knowledge of GMPs, ISO 13485, and qualification processes (IQ, OQ, PQ).
• Familiarity with metal and plastics processing and mechanical assembly.
• Experience in a cleanroom is preferred.
• Six Sigma knowledge preferred; ability to mentor others is a plus.
• Experience with Agile and Oracle data systems is a plus.