About Us: GE Healthcare’s Surgery business offers a range of market-leading intra-operative and interventional imaging products. Surgery's C-arm imaging products are integral in many fields including general surgery, orthopedics, neurosurgery, urology, cardiology, and GI, and for specialized procedures such as pain management. Surgery prides itself on offering imaging products with superb image quality and an unparalleled technical and clinical support team that ensures the products deliver optimum performance. GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. 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.
Role Summary: Responsible for developing and deploying advanced manufacturing methods in their assigned area across the Global Supply Chain driving process and product quality rigor. As a subject mater expert, they will provide technical leadership for the production teams, and drive manufacturing excellence through new processes and methods that will improve safety, reduce product cost and improve product quality.
Essential Responsibilities: • Qualification of equipment, tooling and processes using accepted methods of IQ, OQ and PQ. • Manage preventative maintenance and repair of manufacturing equipment • Drive “Brilliant Factory” initiatives to implement automation of assembly and test processes, as well as automated data management of factory key performance indicators, KPI. • Drive improved product quality by identifying manufacturing issues, developing advanced manufacturing cost-effective solutions, and overseeing successful implementation into production. • Ensuring regulatory compliance through Qualification & Validation. Responsible for ensuring rigor in determining processes requiring validation, development of plans and analysis criteria, execution and final analysis and acceptance. • Work with manufacturing leadership to identify and resolve manufacturing and quality problems related to methods, processes, tooling, equipment and product design. • Ensure early focus on manufacturability in NPI programs. Drive rigor in process capability assessment, process layout, tooling and equipment development and QMS Design Transfer execution • Ensure the use of Six Sigma and Lean for continuous improvement and in new product programs. • Monitor and improve productivity, while ensuring all customer commitments are met in a timely, quality and cost-conscious manner. • Recognized as a key manufacturing technology leader across the Global Supply Chain, demonstrating strong communication and influencing skills. • Lead initiatives with wide business impact. Ensure consistent and effective deployment across the Global Supply Chain.
Quality Specific Goals: 1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position 2. Complete all planned Quality & Compliance training within the defined deadlines 3. Identify and report any quality or compliance concerns and take immediate corrective action as required 4. Knowledge and understanding of CAPA, document control, design transfer, verification, validation, acceptance activity, DMR, DHR and electronic signature requirements to ensure that product, equipment, tools, processes, software, training and documentation meet requirements.
Qualifications/Requirements: 1. Bachelors of Science in Engineering or related field (Science) 2. Minimum of 5 years of industrial experience in a manufacturing environment. 3. Demonstrated experience owning production processes, and growing capability, yield and quality. 4. Strong Six Sigma skills in DMAIC 5. Strong communication Skills, written and verbal. 6. Demonstrated ability to develop metrics and consolidate /distill data for both upward and horizontal interpretation. 7. Strong Lean background and training as well as Six Sigma skills in DMAIC 8. Demonstrated experience and leadership in process validation and equipment qualification. 9. Good Strategic Thinker; Strong Influencing Skills; Resourceful and inclusive, comfortable working thru pushback. 10. Experience working with global teams 11. Willing to travel internationally and domestically up to 20% of the time
Desired Characteristics: 1. 10+ years industrial experience in Manufacturing Engineering 2. 6-sigma DMAIC BB/MBB certified 3. Experiences in HLA and Process Intensive manufacturing 4. Product and Process Development experience 5. Solid working knowledge of GEHC QMS procedures for GMP 6. Experienced owning business initiatives and driving behavior of large teams 7. Experienced developing tools and templates 8. Demonstrated program or project management skills 9. Working knowledge of GEHC IT Tools and Mfg Systems. 10. Experience developing SW requirements and supporting SW developments
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