The Principal Mechanical Engineer is responsible for design, development, implementation, and analysis of medical devices. Performs engineering design evaluations. May develop a range of products. Recommends alterations to development and design to improve quality of products and/or procedures. Identifies functional problems and suggests resolutions. Complies with applicable quality systems, medical device regulations and pharmaceutical regulations. Works under minimal supervision and is expected to be able to lead the work of other more junior engineers as well as technicians. Coordinates their work with Teva Device Design Centers, Teva Drug-Device Project Teams and manufacturing sites, Contract Development Organization (CDO) or Contract Manufacturing Organization for feasibility, device development and design control activities.
Essential Duties & Responsibilities:
|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 utilizing SolidWorks, bill of materials generation, tolerance analyses, FEA and Flow Simulation reports|
|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/review Risk Management File documents including User FMEA, Design FMEA, Process FMEA and material selection rational for biocompatibility.|
|Generate, execute, and/or review Design Verification protocols as well as write technical reports. Must have a working knowledge of statistics including determination of sample size, design of experiments and ANOVA.|
|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.|