Staff External Manufacturing Engineer
Location:
Cincinnati , Ohio
Posted:
April 02, 2017
Reference:
8330170109-en-us

Ethicon, Inc. is a surgical care company within the Medical Devices sector of Johnson & Johnson family of companies.  We are currently recruiting for a Staff Manufacturing Engineer for External Operations to be based in Cincinnati, Ohio.
 
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 External Manufacturing Engineer is responsible for functioning as an integral member of a team in support of manufacturing operations performed by external manufacturers, providing technical services to insure quality, cost and performance objectives are met. The Staff External Manufacturing Engineer will also be responsible for ensuring supply continuity of mechanical purchased finished goods.  Additional responsibilities include:
 
  • Completing failure investigations for customer complaints, CAPA's and NCR's
  • Work with external suppliers to validating process changes related to mechanical devices, and replacement of materials or tooling
  • Completing component or system qualifications to meet international regulatory and quality standards (ISO, RoHs, etc.);
  • Initiating/leading/supporting cost improvement projects and business continuity initiatives
  • Interface with External Manufacturers and Ethicon External Operations groups and assist by providing technical support to insure External Manufacturers are properly evaluated/selected/qualified
  • Provide technical support to assist in establishing and maintaining GMP compliant processes
  • Perform engineering studies and analyses on existing manufacturing processes to improve process reliability, product quality and cost
  • Using appropriate statistical techniques to develop validation protocols, complete process capability studies and process validation on both internal and supplier processes
  • Actively participate in other team activities to help insure total team success; take an active role in learning for self and others to further company objectives; complete assignments involving a specific phase of an engineering project and or line support activity.
  • Assist in determining objectives and planning schedules of specific task within a given project activity; provide line support responsibilities for specific products.
  • Coordinate technical and or business issues with internal and external customers {typical scope is at a business unit level)
  • Apply comprehensive and diverse knowledge of engineering business principles to a broad range of assignments
  • Plan, conduct and direct engineering business projects to completion {typical scope is at business unit and or External Manufacturing level)
  • Coordinate and direct activities of other technical support staff and delegate their assignments as required
  • Apply comprehensive and diverse knowledge of engineering business principles to a broad range of assignments
  • Plan, conduct and direct technical business projects to completion (typical scope is at External
  • Manufacturing or Operations level)
  • Devise or adapt new methods, using a full understanding of procedures and various product support improvement techniques
  • Maintain clear communication with internal and external business partners regarding expectations, satisfaction, or quality of results
  • Contribute to or lead development, design, and the validation of existing & start up manufacturing & assembly operations that meet objectives for product quality, cost & performance.
  • Partnering with NPD to ensure product is properly designed for manufacturability & assembling & Manufacturers are properly selected & qualified and manufacturing processes are robust & reliable.
  • Lead, manage or complete assignments involving a specific phase(s) of an engineering projects, design changes projects, Technology Transfer projects & / or line support activities.
  • Execute seamless and timely transition of design or process changes with external partners ensuring all quality and regulatory requirements are met
  • No direct reports.  Up to 50% travel, including international.  Some travel may be on short notice.
  • Other responsibilities may be assigned; not all responsibilities listed may be assigned

Qualifications
  • A minimum of a Bachelor’s degree in engineering is required for this position.  A Master's Degree in Mechanical Engineering is preferred.
  • A minimum of 9 years’ experience in industry is required with a minimum of 3 years’ experience in the mechanical field of engineering. A demonstrated ability within a Medical Device environment is an asset for this role.
  • Knowledge and practical experience with process development, process controls and process validation {e.g. control plans, pFMEAs, SPC, etc.) is required.
  • Familiarity with manufacturing techniques such as device assembly is preferred.
  • The ability to perform independent assessment of component or process alternatives or modifications is preferred
  • The ability to lead technical projects with external manufacturers and suppliers is required.
  • Ability to develop cross-functional partnerships (R&D, Commercial Operations, Quality, RA, etc.) is required.
  • Experience in service & repair operations for mechanical medical devices is a plus.
  • Experience with packaging of sterile devices is highly desired.
  • Experience working with global supply chain and non-US raw material and finished goods suppliers is highly desired.
  • Prior experience participating in process efficiency improvement, technology transfer into base business, or cost reduction projects is highly desired.
  • Process Excellence training or certification is highly desired (Six Sigma and/or Lean Green or Black Belt)
  • Knowledge of statistical tools such as ANOVA, DOE, or Hypothesis Testing Tools is a plus.
  • Experience in an environment where trade secrets and intellectual property needs to be protected, would be a plus.
  • All candidates must possess excellent verbal and written communication skills, strong decision making and problem solving skills, and outstanding interpersonal relationship and people skills. The ability to function as a team player and work in a matrixed, cross functional organization is a must.
  • This position is based in Cincinnati, Ohio and may require up to 50% travel both domestic and international.

Primary Location
United States-Ohio-Cincinnati
Organization
Ethicon Endo Surgery Inc (6041)
Job Function
Engineering (Generalist)
Requisition ID
8330170109

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