Johnson & Johnson is looking for an R&D Engineer to support the process of developing foot and ankle orthopedic products with a focus on improving surgeon experience and patient outcome.
Requirements
- Experience in the design and development of medical devices, mechanical products, or biomechanical systems.
- Experience and proficiency using parametric solid modeling and CAD software (PTC Creo, SolidWorks, etc.) to create and document parts and assemblies.
- Ability to develop test protocols, and experience with medical device and creation/maintenance of design history files (DHFs).
- Knowledge of MDR/FDA (510(k) submissions) process and regulation controls, and/or IDE clinical studies.
- Experience working in medical device regulations, including GMP (Good Manufacturing Practices), QSR (Quality Systems Regulations) and ISO (International Organization for Standardization) quality requirements.
- Knowledge of component manufacturing processes (including CNC machining, laser cutting, rapid prototyping, injection molding, etc.) is preferred.
- A Mechanical Engineering degree is preferred.
Responsibilities
- analyzing and collecting voice of customer
- defining/interpreting project requirements
- using 3D modelling software along with your engineering skills to design and develop surgical implants, instruments, and/or test fixtures
- work with product development engineers to complete design verification and validation activities such as drawing reviews, tolerance stack analysis, mechanical testing, finite element analysis and simulated surgical cadaveric labs
- develop test protocols
- creation/maintenance of design history files (DHFs)
- methods of rapid design iteration including 3D printing
Other
- A minimum of a Bachelor's degree in Engineering or related degree from an accredited university or college and 2-4 years of experience.
- Highly motivated and can work independently on multiple projects under general direction and can exhibit attention to detail.
- The ability to apply a “hands-on” approach to find creative solutions to complex and exciting problems.
- Able to establish and cultivate collaborations and partnerships internally and externally.
- Able to prioritize project priorities.
