Engineer II R&D

Johnson & Johnson Innovative Medicine•Irving, TX

About The Position

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech 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.

Requirements

Bachelor’s degree in mechanical or biomedical engineering or related field, or equivalent required.
At least 2-4 years related engineering experience required.
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.
Requires understanding and application of a theoretical or scientific discipline – including the underlying principles involved, as opposed to practices (e.g. chemistry).
Applies 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.
Proficiency with MS Office required.

Nice To Haves

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.
Experience with polymer-based manufacturing and/or device design preferred.
Working knowledge of Design Control preferred.
Designing with 3D CAD tools, including SolidWorks and rapid prototyping, including hands-on manual prototyping, SLA and FDM is desired.

Responsibilities

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 troubleshoot.
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

Benefits

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours