Ethicon, Inc., a member of the Johnson & Johnson Family of Companies is currently recruiting for a Staff Process Engineer, Product Management - Biosurgery, located in Somerville, NJ.
Ethicon Biosurgery is a leading provider of proven solutions to address a range of bleeding and leaking situations, from routine to problematic, during surgical procedures. Our product portfolio includes proprietary oxidized regenerated cellulose hemostats; gelatin powder and sponges; a flowable hemostatic matrix; human thrombin, and fibrin sealants.
The Staff Process Engineer, Product Management will be responsible for designing and developing new medical devices from concept through product launch. This individual will conduct research toward new product development or existing product improvement and contribute inventions, new design or techniques to solve technical problems or improve existing products or processes.
Principal Duties and Responsibilities:
- 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 Research & Development or other transferring partners into the Supply Chain (Johnson & Johnson or external) and the launch of products into regional or global commercial markets.
- Plan and direct 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.
- Develop 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.
- Participate or lead strategic decision making process including make vs. buy analysis, site selection decisions, and make balanced recommendations to management with regard to short-term and long-term program objectives.
- Actively participate in Quality Function Deployment, design Failure Mode Effects Analysis (FMEA), project plan development, updates to management board and other core team activities to help establish project direction and ensure total team success.
- A minimum of a Bachelor’s degree in Engineering, Science or a related technical discipline is required. Advanced degree preferred.
- A minimum of 6 years of process engineering experience is required.
- Experience working in a FDA regulated environment is preferred.
- Experience in the Medical Device, Pharmaceutical, Consumer and/or Biologics industries is preferred.
- Demonstrated experience in new product process design and development for new products/processes required.
- Demonstrated experience in new product process design and development and implementation of these processes into manufacturing operations preferred.
- Knowledge of validation requirements for Medical Devices, Pharmaceuticals and/or regulated industry is required.
- Aseptic and/or Clean Room processing experience is preferred.
- Demonstrated experience in the development and execution of project plans (time, budget and program management) is preferred.
- Experience leading technical teams and mentoring less senior engineers preferred.
- Global experience is preferred.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook) is required.
- Knowledge of statistical software (i.e. Minitab) is preferred.
- Knowledge of Six Sigma/Process Excellence tools and methodologies (DMAIIC, DMADV, Lean), including Design of Experiments, capability analysis, sampling statistics and techniques, CTQ flow down, C/E Matrix, pFMEA, fish bone diagrams, preferred.
- Lean or Six Sigma Green or Black Belt Certification is preferred.
- Must have excellent communication skills.
- The ability to select and execute the appropriate statistical tools and provide the practical conclusions and inferences during process development and validation activities is required.
- The ability to collaborate effectively with all levels of management and influence decision-making across a matrix organization is required.
- This position is based in Somerville, NJ and will require up to 35% domestic and international travel.
United States-New Jersey-SomervilleOrganization
Ethicon Inc. (6045)Job Function
Process EngineeringRequisition ID