Generate/review Risk Management File documents including User FMEA, Design FMEA, Process FMEA and material selection rational for biocompatibility.
Execute/participate in/coordinate R&D development activities such as design of prototypes, design of experiments, design of test fixtures, perform testing activities, draft experimental protocols and reports. Perform product and process root cause analysis and problem solving.
Generate/review design output documentation such as component and assembly drawings, bill of materials generation.
Execute/review product commercialization activities such as design or assembly, part and cost reduction including interfacing with the device manufacturer, component suppliers, and assembly equipment vendors.
Generate, execute, and/or review Design Verification protocols as well as write technical reports
Implement transfer of design to manufacture of product. Generate/review manufacturing documentation such as assembly work instruction, validation protocols and reports, batch records, and IQ OQ PQ equipment qualifications.
Follows Teva Safety, Health, and Environmental policies and procedures.
Other projects and duties as required/assigned.
University Bachelor of Science in Mechanical/Biotechnology/Quality or Biomedical Engineering - required
Pharmaceutical / Medical Device industry experience, with extensive experience in medical devices -2-5 years Required
Process validation and manufacturing experience
Polymer Science and/or Injection Molding
Experience in Quality and regulation of medicinal product
Experience in leading Risk management process
Ability to work in a team and on your own
Speak fluent English
The position located in Kfar Saba