Ethicon, Inc., a member of the Johnson & Johnson Family of Companies is currently recruiting for a Senior Process Engineer, located in Cornelia, GA.
The Ethicon business offers a broad range of products, platforms and technologies-including sutures, hemostasis products, surgical staplers, trocars, energy devices and synthetic mesh devices-that are used in a wide variety of open and minimally invasive surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of surgery.
The Senior Process Engineer will:
- Plan, coordinate, document and implement all qualification and validation activities of new or improved manufacturing process equipment and processes.
- Perform validations, and project engineering activities for complete project or portions of major projects to optimize or transfer manufacturing processes.
- Provide day-to-day troubleshooting and technical assistance to the site operations.
- Develop, monitor, and effectively use dashboards, control charts and operational indicators, taking action to correct those situations that are not in line with established controls or targets.
- Effectively manage resources allocated to assigned projects to meet quality, financial, Environmental, Health and Safety, and product/process improvement targets.
- Assist in new and existing process and equipment design.
- Execute Process Excellence projects directed toward Design Excellence of new products, as well as Lean/Six Sigma of both new and existing processes, including but not limited to safety and ergonomic improvements, quality improvements, cost reductions and productivity improvements.
- Prepare oral and written technical and progress reports regarding projects.
- Plan, conduct and direct product/process studies, including entire projects that require an advanced knowledge of injection, extrusion, needles or sutures processes.
- Work with manufacturing operators and supervisors to develop and install processes and control systems and then troubleshoot when necessary.
- Write technical experimental protocols and completion reports.
- Set objectives, plans, and schedule multiple projects to accomplish defined objectives to meet manufacturing goals.
- Work on projects to qualify new or improved equipment, processes and products.
- Develop and improve existing processes and methods for control and troubleshooting of manufacturing technical problems.
- Ensure fulfillment of all regulatory, safety, industrial hygiene and environmental requirements for implementation of new products, processes, and equipment.
- Ensure equipment uptime through the expedient, effective resolutions of production equipment problems to meet customer service objectives for line fill rates.
- Troubleshoot issues related to part quality, as well as lead implementation of changes to correct.
- Independently perform process and project activities with general instruction.
- Manage line priorities to assure that all activity is directed in alignment with Business Unit objectives and serve as the process technical expert for one area within the plant.
- Provide an ongoing analysis of current process capability to assure existing manufacturing systems are sufficient to achieve company objectives.
- Recommend and coordinate process improvement activities with the Line Support and Operations groups (Lean initiatives, etc.).
- Comply with all federally regulated programs.
- Adhere to Johnson & Johnson environmental and safety policies and guidelines.
- Comply with all job specific safety procedures and utilize Personal Protective Equipment (PPE) when necessary.
- Support Manufacturing Equipment Excellence (ME2) including 6S and Operator Asset Care.
- Support efforts to develop and sustain a culture of waste reduction and affect an ongoing and sustained improvement in product and process quality.
- A minimum of a Bachelor's degree in Engineering, a Science or a related technical discipline is required. Mechanical Engineering degree is preferred.
- A minimum of 5 years of related Engineering experience is required.
- Experience working in a manufacturing environment is required.
- Medical Device, Pharmaceutical or Consumer regulated industry experience is preferred.
- Knowledge of Good Manufacturing Practices (GMPs) required.
- Knowledge of ISO preferred.
- Experience with synthetic absorbable polymers, injection molding, extrusion technology, metallurgy preferred.
- Experience troubleshooting manufacturing equipment is required.
- Knowledge of manufacturing processes (e.g. Just in Time (JIT), KANBAN, Continuous Flow Manufacturing (CFM), Pull Systems, Lean/Six Sigma, Process Excellence) preferred.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) is required.
- Knowledge of AutoCAD required.
- Proficiency in Statistical Process Control (SPC) theory and its application is preferred.
- Knowledge of Design of Experiment (DOE) concepts preferred.
- Process Excellence/Six Sigma (Green or Black Belt) Certification is preferred.
- Project management experience is preferred.
- The ability to collaborate with all levels of management in a cross-functional team environment is required.
- This position will require up to 10% domestic and international travel.
Ethicon Inc. (6045)Job Function