GE HealthCare—Manufacturing Process Engineer

Job description

Description: Job Description Summary Responsible for developing, validating, improving, and sustaining manufacturing processes that ensure product quality, regulatory compliance, operational efficiency, and employee safety. This role partners closely with Manufacturing, Quality, Engineering, Supply Chain, Regulatory, and Product Development teams to optimize manufacturing performance, support new product introductions, and drive continuous improvement initiatives. The Manufacturing Engineer plays a key role in ensuring robust, compliant, and scalable manufacturing processes while fostering a culture of quality, safety, and operational excellence. 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. Job Description Key responsibilities include: In this role you will: - Develop, qualify, validate, and sustain manufacturing processes, equipment, tooling, fixtures, and test methods to ensure product quality, operational efficiency, and regulatory compliance. - Conduct process risk assessments using PFMEA and implement effective risk mitigation strategies to improve process robustness and reliability. - Create and maintain manufacturing documentation, including SOPs, work instructions, process specifications, and operator training materials. - Lead manufacturing process validation and ensure compliance with ISO 13485, GMP, company quality standards, and applicable regulatory requirements. - Investigate process deviations, non-conformances, customer complaints, and CAPA activities, partnering with Quality teams to implement sustainable corrective and preventive actions. - Drive Lean Manufacturing and continuous improvement initiatives using methodologies such as Kaizen, DMAIC, 5 Why, Poka-Yoke, statistical analysis, and data-driven decision making to improve productivity, yield, cycle time, FPY, and cost. - Monitor manufacturing performance metrics, identify process bottlenecks, and implement improvements that enhance operational excellence and customer satisfaction. - Support New Product Introduction (NPI) by collaborating with R&D and Product Engineering on Design for Manufacturability (DFM), process planning, tooling development, equipment qualification, and manufacturing readiness. - Lead implementation of engineering and manufacturing changes, evaluating their impact on quality, compliance, cost, and production continuity while coordinating cross-functional execution. - Promote a strong safety culture by ensuring manufacturing processes comply with Environmental, Health & Safety (EHS) requirements and by supporting risk reduction initiatives and incident investigations. - Partner effectively with Manufacturing, Quality, Engineering, Supply Chain, Regulatory, and Operations teams to achieve business objectives and resolve technical and operational challenges. - Provide technical guidance, training, and mentoring to operators, technicians, and junior engineers while fostering knowledge sharing and continuous capability development. - Influence stakeholders through technical expertise, effective communication, and collaborative problem-solving to achieve project and operational goals. - Demonstrate ownership and accountability by delivering projects, resolving manufacturing issues proactively, and balancing quality, compliance, customer expectations, and business priorities. - Continuously seek opportunities to improve manufacturing processes, adopt innovative solutions, and support long-term operational and business growth through strategic thinking and learning agility. Basic Qualifications - Bachelor's degree in Industrial Engineering, Mechanical engineering or related technical degree - Minimum 5+ years of experience in manufacturing engineering, process engineering, or process improvement within a regulated manufacturing environment. - Experience with manufacturing process validation, PFMEA, process capability, and statistical analysis tools. - Working knowledge of Lean Manufacturing methodologies including 5S, Kaizen, Poka-Yoke, and continuous improvement principles. - Experience leading structured problem-solving activities using methodologies such as DMAIC, 5 Why, and Fishbone Analysis. - Strong stakeholder management and cross-functional collaboration skills. - Excellent verbal and written communication skills with the ability to train and mentor manufacturing teams. - Demonstrated ability to manage multiple priorities while delivering high-quality results. Desired Characteristics - Experience working in a medical device or other highly regulated manufacturing environment. - Knowledge of Six Sigma methodologies and statistical process control techniques. - Strong ownership mindset with a commitment to quality, compliance, and operational excellence. - Excellent analytical and problem-solving capabilities with the ability to make data-driven decisions. - Customer-focused approach with an understanding of how manufacturing performance impacts product quality and patient outcomes. - Demonstrated ability to influence stakeholders without direct authority. - Experience mentoring junior engineers, technicians, or manufacturing personnel. - Continuous improvement mindset with a passion for innovation and operational excellence. - Ability to adapt quickly to evolving technologies, manufacturing processes, and business priorities. 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 you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. Disclaimer: GE HealthCare will never ask for payment to process documents, refer you to a third party to process applications or visas, or ask you to pay costs. Never send money to anyone suggesting they can provide employment with GE HealthCare. If you suspect you have received a fraudulent call , please fill out the form below: https://www.ge.com/careers/fraud Additional Information Relocation Assistance Provided: Yes