GE HealthCare Manufacturing Engineer 

United States, Wisconsin 

519321994

Key Responsibilities:

• Develop, implement, and optimize manufacturing processes for medical devices, ensuring compliance with regulatory and quality standards.
• Support new product introductions (NPI) by collaborating with Design Engineering, Quality, and Production teams.
• Create and maintain process documentation including work instructions, process flow diagrams, PFMEAs, and control plans.
• Lead root cause analysis and implement corrective and preventive actions (CAPA) for process-related issues.
• Identify and implement continuous improvement initiatives using Lean and Six Sigma methodologies.
• Support equipment selection, validation (Equipment Qualifications), and maintenance planning.
• Monitor key process metrics and drive improvements in yield, cycle time, and cost.
• Ensure compliance with internal quality systems.

Qualifications:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or a related field.
• 2+ years of experience in a manufacturing engineering role, preferably in the medical device or regulated life sciences industry.
• Strong understanding of GMP, FDA regulations, and ISO.
• Experience with process validation, statistical analysis, and root cause investigation.
• Proficiency in CAD software (e.g., SolidWorks, AutoCAD, Creo) and Microsoft Office tools.
• Excellent problem-solving, communication, and project management skills.

Preferred Qualifications:

• Experience with cleanroom manufacturing.
• Lean Six Sigma certification (Green Belt or higher).
• Familiarity with ERP and MES systems.
• Knowledge of automation and manufacturing technologies such as Automated Pick and Place, Adhesive Dispense, Contact and Non-Contact Measurement systems and Wirebonding Equipment.