Engineer 2, R&D - Johnson and Johnson

Mentor Worldwide LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Engineer 2, R&D located in Irving, Texas or Raritan, NJ.

Mentor is a leading supplier of breast implants in the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow breast surgery patients to improve their quality of life. The company is focused on two strategic areas: breast reconstruction and breast augmentation. MENTOR ® is the only manufacturer whose silicone breast implants are made in the U.S.A. For over 20 years, more than 5 million women have chosen MENTOR ® Breast Implants.

Position Summary: Provides engineering and design services to manufacturing and production engineering groups. Develops concepts, designs and details for machines, tools, fixtures, and products. The Engineer II will contribute to cross-functional multidisciplinary project teams (R&D, manufacturing, marketing, regulatory, etc.) in the design, development and manufacturing of breast implants, tissue expanders, and related products and processes to fulfill clinical needs within regulatory requirements.

Duties & Responsibilities:

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Supports bench and pilot scale up operations, including equipment assembly, medium preparation, in process sample analysis, and the operation of reactors.
• Participates in the scale up of and optimization of processes and technologies.
• Assists in performing downstream processing by preparing equipment, preparing and controlling standard operating procedures, batch records and other compliance documents.
• Provides technical support to purification operations in pilot plant, including equipment cleaning/setup/prep, buffer preparation, in process testing and so on.
• Supports and helps troubleshooting and problem solving.
• Participates in the transfer and implementation of new processes and technologies into the pilot plant, commercial manufacturing and contract manufacturing.
• Provides input to the development process validation plan. May develop procedures and processes within broader protocols.
• Conducts research, analysis or processes within a larger R&D activity
• May develop and implement standards for reporting and operations
• Ensures completion of activities within compliance and on-time
• May identify and implement process level efficiencies
• Supports safety and environmental initiatives by testing equipment prior to starting production.
• Uses analytical/technical expertise to contribute to product development/testing.
• Ensures that project guidelines are followed, and processes are complete.
• May coordinate with outside vendors or regulatory officials
• May oversee reporting or regulatory processes or parts of processes
• May be responsible for project or process reporting and tracking
• May provide limited oversight of more junior staff on initiatives and projects
• Provide training of new employees on covered jobs, and answering job-related questions in one or more areas
• May monitor budgets as part of process administration
• Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).
• Responsible for communicating business related issues or opportunities to next management level
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

Qualifications:

Required :

• A minimum of a Bachelor's degree in mechanical engineering, biomedical engineering OR other related degree is required.

• A minimum of 2-4 years related industrial engineering experience with a Bachelor's degree OR 1-4 years of experience with a Master's degree is required.

• Experience with standard practices and techniques in specific situations, adjusts and correlates data, and follows operations through a series of detailed steps and processes.
• Working knowledge of basic statistics is required.
• Experience designing with 3D CAD tools, including SolidWorks and rapid prototyping, including hands-on manual prototyping
• Proficiency with MS Office required

Preferred :

• MS degree is preferred

• Experience in design, development and commercialization of Class I-II medical devices is preferred.

• Experience with mechanical testing and/or laboratory test method development is preferred.

• Skills and experience to develop appropriate protocols for conducting analysis.
• Specialized knowledge level, with sufficient experience and skill in techniques to independently determine how to set up and execute complex analysis.
• Experience with polymer-based manufacturing and/or device design preferred.
• Working knowledge of Design Control preferred.

At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .