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Staff Process Engineer
Requisition ID: 5744180312
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 Staff Process Engineer will serve as a project leader and working technical member of the Manufacturing Engineering Project Team supporting the Absorbable Products Business Unit in Cornelia, GA.
· You will lead and/or participate as a key technical team member in cost improvement projects (CIPs), capacity expansion projects and material and supplier qualification projects.
· Provide the technical feedback to plan, design, develop, and validate the manufacturing processes for new products.
· Collaborate with multi-functional teams including: Manufacturing, Research and Development (R&D), Quality Engineering, Product Management, Analytical Labs, Procurement and Environmental/Safety.
· Prepare process development, process validation and material qualification protocols.
· Lead all activities related to their execution, including the preparation and approval of the company’s change control process deliverables, including completion reports, detailed process specifications and work instructions.
· The Staff Process Engineer will act as a mentor to more junior members of the staff.
· The areas in Absorbable Business Unit to be supported by the position are to be Synthesis Processes for Absorbable Polymers, Extrusion Processes, and Fiber and Textile Processes.
· The Staff Process Engineer will use knowledge of scientific techniques and Process Excellence to design and develop safe, effective and efficient processes in support of the company's strategies, goals, and objectives.
· Observe all regulatory requirements such as Good Manufacturing Practices (GMPs), ISO, FDA and internal policies applicable to their area of responsibility and align with Johnson & Johnson Safety/Environmental requirements and safe working conditions and practices.
· Make decisions independently on engineering problems and methods and prepare technical reports, project updates and status reports for team and senior management.
· A minimum of a Bachelor's degree in Chemical Engineering, Plastics Engineering, Mechanical Engineering, Polymer Science, Materials Science or a related technical discipline
· An advanced degree in Engineering is preferred.
· A minimum of 7 years of Process Engineering experience or alternatively 5 years of Process Engineering experience with an Advanced Degree in Engineering
· Experience working in a regulated industry (i.e. Pharma, Medical Device) strongly preferred.
· Prior experience leading the execution of cost improvement projects (CIPs), capacity expansion projects, new process development and validation preferred.
· Knowledge of polymer melt processing, polymer synthesis, and/or polymer extrusion is strongly preferred.
· Knowledge of the validation requirements for Medical Device manufacturing is strongly preferred.
· Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook) is required. Knowledge of statistical data analysis tools (e.g. Minitab) preferred.
· Knowledge of Six Sigma/Process Excellence Tools and Methodologies (i.e. DMAIIC, DMADV, Lean), including Design of Experiments, capability analysis and sampling statistics and techniques preferred. Process Excellence/Six Sigma (Green or Black Belt) Certification is preferred.
· Experience in the development and execution of project plans is preferred.
· Strong project management skills, with the ability to manage numerous projects is required.
· Must have excellent written and verbal communication skills.
· Must have strong interpersonal and influencing skills.
· The ability to collaborate with all levels of management in a multi-functional team environment is required.
This position requires up to 10% travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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Ethicon Inc. (6045)