HireDiversity

Somerville, NJ, US

Staff Process Engineer-1415120802

Description

Ethicon, Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for a Staff Process Engineer in the Franchise Operations Development organization located in Somerville, NJ.

The Ethicon Surgical Care business offers a broad range of products, platforms and technologies-including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon Surgical Care 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 electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.

The Staff Process Engineer serves as the operations technical team lead and working member for new product development programs. Provides the technical input to plan, design, develop, and validate the manufacturing processes for new products working with cross-functional teams including: R&D, Quality Engineering, Clinical Teams, Analytical Labs, Procurement, Manufacturing, and Environmental/Safety. The Staff Process Engineer will prepare and review process development and validation protocols, coordinate all activities related to their execution, including the preparation and approval of completion reports, detailed process specifications and work instructions. This individual will lead and coordinate the design and development of mechanical components and systems in support of medical device manufacturing processes. The incumbent is also accountable for appropriate development and execution of process development and validation activities at external suppliers.

The Staff Process Engineer uses knowledge of scientific techniques and Process Excellence to design and develop safe, effective and efficient processes in support of the company's strategies, goals, objectives and product portfolio. They observe all regulatory requirements (GMP's, ISO, FDA, internal policies) applicable to their area of responsibility and comply with J&J Safety / Environmental Requirement and safe working conditions and practices. Makes decisions independently on engineering problems and methods and prepares technical reports, project updates, and status reports for team and senior management. Reviews the work of senior engineers and technicians, estimates manpower needs and schedules, and assigns work to meet completion date.

Qualifications


A minimum of a Bachelor's degree in Engineering or a related discipline is required. An advanced degree and/or MBA is a plus. A minimum of 10 years of Process Engineering experience is required, preferably in the regulated medical device industry. Experience in new product process design and development for new products / processes with multiple factors, responses and interactions is required. Experience with design and development of mechanical components and systems in support of manufacturing production processes is preferred. Working knowledge of the validation requirements for Medical Devices with demonstrated experience is required. The ability to select and execute the appropriate statistical tools and provide the practical conclusions and inferences during the process development and validation activities is required. Knowledge of Six Sigma/Process Excellence Tools (DMAIIC, DMADV, or Lean) which include Design of Experiments, capability analysis, sampling statistics and techniques, CTQ flow down, C/E Matrix, pFMEA, fish bone diagrams, etc., are required. Proficiency with Microsoft Office, CAD, and a working knowledge of statistical software is required. Demonstrated experience in the development and execution of project plans is preferred. Excellent communication skills, making complex issues easy for others to understand and the ability to prepare communications for team and senior management, will be needed. Experience in leading teams and influencing is strongly preferred. Experience mentoring less senior engineers is preferred. Strong time, budget, and program management skills will be required. The ability to travel up to 25% globally will be required.

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Primary Location:North America-United States-New Jersey-Somerville
Organization: Ethicon Inc. (6045)
Job Function: Process Engineering