Job Description Summary

We are looking for a proactive and detail-oriented Manufacturing Engineer to support and optimize production processes within a regulated medical device manufacturing environment. This role is critical in ensuring that products are manufactured efficiently, safely, and in compliance with FDA, ISO, and GMP standards. The ideal candidate will work cross-functionally to drive process improvements, support new product introductions, and maintain high standards of quality and reliability.

Job Description

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.

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.