HireDiversity

Somerville, NJ, US

STAFF PROCESS ENGINEER-8430120627

Description

Ethicon, Inc., now part of the Global Surgery Group of the Medical Device and Diagnostics sector of Johnson & Johnson is recruiting for a Staff Process Engineer - Biosurgery located in Somerville, NJ.

The Global Surgery Innovation organization has recently integrated in 2012 to support all 7 business units under Global Surgery, including General Surgery, Biosurgery, Energy, Acclarent, Mentor, Cardio Vascular, BWI and Sterilmed.

Ethicon Products, part of the General Surgery business unit, has a long history in both absorbable and non-absorbable polymers and leverages this expertise in designing clinically relevant medical devices, including sutures, meshes and films. The individual in this position must be a creative, hands-on engineer needed to design and develop new medical devices from concept through product launch. Responsibilities for this role include conducting research toward new product development or existing product improvement and to contribute inventions, new design or techniques to solve technical problems or improve existing products or processes.

General summary -To lead project teams and provide major input into the design, development, and implementation of processes for new products. Supports flawless transfer of new products and processes from R&D or other transferring partners into the Supply Chain (J&J or external) and the launch of products into regional or global commercial markets.

Principal Duties and Responsibilities (essential functions)

Plans and directs the process development activities for new product projects.

Act as a mentor to more junior staff. Serve as technical process design leader for moderate sized new product projects. Develops implementation cost models for project development and implementation. Provide input and assistance in development of business plan. Serve as Independent Observer for Technical Design Reviews.

Serve as Technical Expert for key technologies. Review and critique developmental protocols and completion reports. Review and critique data analysis and recommendations from testing and development protocols. Collaborate with internal functions and suppliers to finalize product design, material and process selection.

Participates or leads strategic decision making process including make vs. buy analysis, site selection decisions, and makes balanced recommendations to management with regard to short term and long terms program objectives.

Candidates will actively participate in Quality Function Deployment, design FMEA, project plan development, updates to management board & other core team activities to help establish project direction and ensure total team success.

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Qualifications


This position will require a BS in Engineering or relevant discipline, advanced degree preferred with 7 + years of process engineering experience preferred in FDA regulated industry such as medical device, consumer product or pharmaceutical industry.

Demonstrated experience in new product process design and development for new products / processes with multiple factors, responses and interactions is required in this role.

Candidates who possess demonstrated experience in new product process design and development and implementation of these processes into manufacturing operations for current product is preferred.

Candidates with a thorough working knowledge of the validation requirements for Medical Devices, Pharmaceuticals and/or Biologics with demonstrated experience are required. Having experience in Biologics is a plus for this position.
Aseptic Processing experience is a requirement for this position. Experience working with blood based products is preferred.

Demonstrated 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.

Working 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. is preferred for this role.

Proficiency with Microsoft Office and a working knowledge of statistical software is and asset. Candidates who have experience using MiniTab are preferred.

Demonstrated experience in the development and execution of project plans, including strong time, budget, and program management skills

Excellent communication skills; making complex issues easy for others to understand and the ability to prepare communications for team and senior management. Experience in leading technical teams and influencing is required. Mentors less senior engineers is preferred for this role.

Able to travel up to 35% both domestic and international.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

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