This role is responsible for establishing, validating, and improving manufacturing processes for medical device production while ensuring regulatory compliance, product quality, and operational efficiency
Job Summary
This role is responsible for establishing, validating, and improving manufacturing processes for medical device production while ensuring regulatory compliance, product quality, and operational efficiency.
The position supports new process setup, new product introduction (NPI), and continuous improvement initiatives, working closely with production, quality, and engineering teams.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits.
Matching Summary
This role is responsible for establishing, validating, and improving manufacturing processes for medical device production while ensuring regulatory compliance, product quality, and operational efficiency.
Skills & Requirements
Must-have
Process validation and qualification
PFMEA risk assessment
New Product Introduction (NPI) support
Lean manufacturing initiatives
Regulatory compliance
Nice-to-have
Strong analytical problem-solving skills
Solid understanding of materials and quality standards
Working knowledge of company technologies
Leadership experience
Key Requirements
Bachelor’s degree in Mechanical Engineering
4+ years of experience in Manufacturing Process Engineering
Experience in handling regulatory and process audits
Experience with FDA and regulatory requirements
Hands-on experience with design change processes
Experience using ERP systems (Oracle or SAP)
Experience with Six Sigma methodologies and CAPA processes