Johnson & Johnson Careers
SR SUPPLIER QUALITY DEVELOPMENT ENG, SURGICAL ROBOTICS
Requisition ID: 4480190117
Ethicon, is recruiting for a Senior Supplier Quality Development Engineer supporting the Digital Surgery Franchise to be located in Cincinnati, OH.
Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made meaningful contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. This is an opportunity for a key role in bringing exciting new products to market to support the J&J / Google robotics venture. For more information, visit www.ethicon.com.
The Senior Supplier Quality Development Engineer will partner with the Research & Development, Product Management and Advanced Sourcing & Innovation teams throughout both the development & qualification processes as well as the development of the supplier’s quality systems. Key areas include: component requirement reviews, CTQ cascade, component development, test method verification, risk mitigation and component qualification.
The Senior Supplier Quality Development Engineer primary function includes but is not limited to:
- Component development as part of New Product or Process Introduction process.
- Support selection of suppliers for highly engineered components.
- Implementation of Critical to Quality requirements for externally manufactured components ensuring robust processes at suppliers that meet CTQ’s.
- Qualification of highly engineered components including validation, requirements review, and risk management (for example FMEA’s and process control plans).
- Demonstrating strong proficiency in applying established tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions, as well as process and business improvements.
- Leading and/or contributing to test method validation (TMV) and measurement system analysis (MSA), and development of inspection strategies. Practical application of differentiation of test methods utilized (i.e. CMM vs. vision methods) for appropriate tolerances and manufacturing methods.
- Leading and/or contributing to the utilization of various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode and effects analysis).
- Leading and/or contributing to the reliability assessments of product design.
- Leading and/or contributing to root cause investigations using various problem-solving techniques and tools, and assesses effectiveness of corrective actions.
- Conducting and supporting the development of test methods in equipment, process, and product qualifications/validations.
- Developing, implementing, and/or maintaining process control plans that are in accordance with product or process risk level, and ensures those plans are consistently followed.
- Developing, implementing, and/or maintaining production and process controls using appropriate techniques and tools (for example, advanced process monitoring and control tools, methods of statistical process control, process performance metrics).
- Perform or guide completion of gage repeatability and reproducibility (GR&R).
- Interpreting standard and non-standard sampling plans.
- A minimum of BS in engineering from an accredited engineering or relevant science is required. A relevant advanced degree is preferred.
- A minimum of 5 years of work experience is expected. Experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) strongly preferred.
- Applies advanced Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, GxP requirements, and industry best practices to assignments.
- Plans and conducts projects with moderate technical responsibility, complexity, or strategic input.
- Receives summary instructions from technical Quality leaders at various levels, in addition to other functional stakeholders.
- Black Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean) strongly preferred.
- Certified Quality Engineer from ASQ and additional certifications are preferred.
- Advanced knowledge of Quality Engineering/Scientific Method techniques and principles. Applied statistics of increasing complexity
- Strong understanding of GD&T application and ability to transform GD&T requirements for practical application in manufacturing.
- Strong technical understanding of manufacturing equipment and processes.
- Understanding of new product or process introduction processes, and expertise in component qualifications/process validations.
- Experience implementing appropriate risk mitigation with knowledge of product or process and process Risk Management (FDA & ISO standards).
- Experience working in a regulated environment. This includes knowledge of, and experience with, applicable standards, GxP requirements and regulations.
- Design control
- Good documentation practices
- Good manufacturing practices
- Organizational requirements
- Root cause analysis and Corrective Action / Preventive Action (CAPA)
Up to 25% travel required in support of projects.
Ethicon Endo Surgery Inc (6041)