As a Senior R&D Mechanical Engineer in Teva's Innovation Technology Group, working on medical device or combination product development, you will be responsible for the delivery of Mechanical Engineering R&D best practices within Teva’s Global R&D organization. You will have applied knowledge of the regulations, directives, guidelines and standards relevant to the development of medical devices and combination products. Your breadth of engineering expertise, knowledge and practices will be applied to creatively solve complex problems. You will also have experience in the design of precision mechanisms and plastic injection molded components. You will be identified as a Subject Matter Expert in mechanical engineering as it relates to medical device and combination product design, both within the Sterile Device Team and other Teva business units. As such you will also contribute to the development and maintenance of departmental operating systems and processes.
PLANNING, ORGANIZING & CONTROLLING
CONTACT WITH OTHERS
BS/MS in Mechanical Engineering and 3-5 years’ experience with MS or 5-8 years’ experience with BS in Mechanical Engineering; Medical device/Combination products experience preferred in the pharmaceutical industry.
Training in ISO 13485 Design Controls, ISO 14971 medical device risk management and European Medical Device Directive/Regulations
Experience in design for medical device development, manufacturing and assembly processes, failure analysis, stress analysis, DFM, DFSS, high volume manufacturing processes, rapid prototyping, hands on engineering, materials testing, Inspection and measurements
Experience in Quality engineering, reviewing of technical drawings, documents and reports
Competent in the use of statistical methods, Tolerance Analysis GD&T (geometric dimensioning and tolerancing)
Proficient in the use of Solidworks 3D CAD, MS Office Suite, MS Project, simulation and Minitab
Ability to work in a global team environment.