The Job:

Our client is looking to add a Manufacturing Engineer to their rapidly growing team. This engineer will play a hands-on role in supporting and enhancing manufacturing processes for cutting-edge single-use medical devices.

Must Haves:

• Bachelor's degree in engineering.
• Minimum of 5 years of experience in medical device manufacturing.
• Proficiency in SolidWorks designing fixtures and tooling preferred.
• Preferred experience in plastics processing (e.g., extrusion, injection molding, fiber forming).
• Exposure to ISO 13485 standards is a plus.

Responsibilities:

• Evaluate and enhance manufacturing process flow and facility layout to improve safety, quality, and efficiency.
• Diagnose equipment issues and devise corrective measures.
• Develop and execute validation protocols (IQ/OQ/PQ).
• Collaborate with the product development team to design manufacturing tooling and fixtures.
• Optimize production processes through methods.
• Devise and deploy automation solutions.
• Collaborate with Quality Control to address production and supplier quality concerns.
• Provide direct support to production staff to ensure compliance with Good Manufacturing Practices and Standard Operating Procedures.