Job Description Summary
The Industrial Engineer will optimize manufacturing processes for medical devices to ensure compliance with regulatory standards (FDA ISO 13485) while improving efficiency reducing costs and maintaining the highest quality and safety standards. This role involves applying Lean and Six Sigma principles to streamline production enhance throughput and support continuous improvement initiatives in a highly regulated environment.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition turn ideas into world-changing realities and join an organization where every voice makes a difference and every difference builds a healthier world. For more information visit: Description
Roles & Responsibilities
Analyze and improve manufacturing workflows assembly processes and equipment utilization for medical device production.
Develop and implement process optimization strategies while ensuring compliance with FDA regulations ISO 13485 and GMP (Good Manufacturing Practices).
Conduct time studies capacity analysis and line balancing to improve efficiency and reduce waste.
Collaborate with Quality Assurance to ensure processes meet stringent quality and validation requirements.
Support Design for Manufacturability (DFM) during new product introduction and scale-up.
Drive autonomation initiatives digitization and integration of advanced technologies to improve precision and consistency. Hands on experience in Karakuri will be an advantage
Monitor KPIs such as yield cycle time and cost per unit; implement corrective actions as needed.
Lead continuous improvement projects using Lean Six Sigma and Kaizen methodologies.
Develop Value Stream by minimizing NVA processes. Well versed with production planning monitoring
Ensure compliance with health safety and environmental standards in all operations.
Qualifications & Skills:
Education: Bachelors degree in industrial engineering.
Experience: 712 years in manufacturing or other regulated industries (pharma biotech Automotive).
Technical Skills:
Knowledge of FDA 21 CFR Part 11 ISO 13485 and GMP requirements.
Proficiency in CAD tools simulation software and ERP systems.
Expertise in Lean Manufacturing and Six Sigma methodologies.
Soft Skills: Strong analytical ability problem-solving communication and project management skills.
Preferred Certifications:
Lean Six Sigma Green Belt or Black Belt
ASQ Certified Quality Engineer (CQE)
Experience with Industrial Engineering Skills
Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race color religion national or ethnic origin sex sexual orientation gender identity or expression age disability protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus and drive ownership always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support
Additional Information
Relocation Assistance Provided: No
Job Description SummaryThe Industrial Engineer will optimize manufacturing processes for medical devices to ensure compliance with regulatory standards (FDA ISO 13485) while improving efficiency reducing costs and maintaining the highest quality and safety standards. This role involves applying Lean...
Job Description Summary
The Industrial Engineer will optimize manufacturing processes for medical devices to ensure compliance with regulatory standards (FDA ISO 13485) while improving efficiency reducing costs and maintaining the highest quality and safety standards. This role involves applying Lean and Six Sigma principles to streamline production enhance throughput and support continuous improvement initiatives in a highly regulated environment.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition turn ideas into world-changing realities and join an organization where every voice makes a difference and every difference builds a healthier world. For more information visit: Description
Roles & Responsibilities
Analyze and improve manufacturing workflows assembly processes and equipment utilization for medical device production.
Develop and implement process optimization strategies while ensuring compliance with FDA regulations ISO 13485 and GMP (Good Manufacturing Practices).
Conduct time studies capacity analysis and line balancing to improve efficiency and reduce waste.
Collaborate with Quality Assurance to ensure processes meet stringent quality and validation requirements.
Support Design for Manufacturability (DFM) during new product introduction and scale-up.
Drive autonomation initiatives digitization and integration of advanced technologies to improve precision and consistency. Hands on experience in Karakuri will be an advantage
Monitor KPIs such as yield cycle time and cost per unit; implement corrective actions as needed.
Lead continuous improvement projects using Lean Six Sigma and Kaizen methodologies.
Develop Value Stream by minimizing NVA processes. Well versed with production planning monitoring
Ensure compliance with health safety and environmental standards in all operations.
Qualifications & Skills:
Education: Bachelors degree in industrial engineering.
Experience: 712 years in manufacturing or other regulated industries (pharma biotech Automotive).
Technical Skills:
Knowledge of FDA 21 CFR Part 11 ISO 13485 and GMP requirements.
Proficiency in CAD tools simulation software and ERP systems.
Expertise in Lean Manufacturing and Six Sigma methodologies.
Soft Skills: Strong analytical ability problem-solving communication and project management skills.
Preferred Certifications:
Lean Six Sigma Green Belt or Black Belt
ASQ Certified Quality Engineer (CQE)
Experience with Industrial Engineering Skills
Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race color religion national or ethnic origin sex sexual orientation gender identity or expression age disability protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus and drive ownership always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support
Additional Information
Relocation Assistance Provided: No
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