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EsophyX (EndoGastric Solutions, Inc.) RandD Design Engineer in Redmond, Washington

Title: RandD Engineer Reports to: Vice President, RandD and Operations, RedmondStatus: Regular, Full-Time, Exempt Job Summary: Responsible for moderately complex research, development, testing and implementation of mechanical systems and systems design with human factors considerations for medical products/devices. Works with the cross-functional teams to develop specifications for product development and prototyping. Develops product design specifications and documents in accordance with company, ISO-13485, FDA and other requirements. Builds product prototypes. Test and verifies product design and prototypes and writes design verification/validation protocols. Writes verification and validation test reports. Job Responsibilities: * Responsible for the initiation, design, development, execution, and implementation of medical devices using engineering and scientific principles. *Invents prototypes and reduces to practice concepts in a rapid prototyping environment and submits idea disclosures. *Designs components or functional systems and modifies existing designs to develop or improve products and facilitate manufacturing operations. *Gathers information, makes studies; prepares original rough sketches; performs necessary calculations; coordinates design criteria with engineering, manufacturing, tooling, material, and planning groups. *Checks completed layout and details drawings and specifications prepared by others for design assignments. *Participate in analyzing, evaluating, and designing solutions to problems affecting product manufacturability or reliability. *Interact with Marketing/Sales, Quality and Manufacturing Engineering (where appropriate) to resolve manufacturing issues associated with product design. *Provide support in new product transition to Manufacturing. *Interact with vendors, where appropriate, to provide processing improvements through outside technology. *Plans and executes laboratory research and draws conclusions from test results. *After training, may work in tissue lab. *May train and/or provide direction to technicians. *Designs, procures, and fabricates tooling and fixtures. *Prepares standard reports/documentation to communicate results to the technical community. *Design and coordinates standard engineering tests and experiments, *Perform related duties as assigned by Lead or Manager. Position Requirements: *A typical minimum education/years of experience : BS in Mechanical Engineering/Technical field 3+ years’ experience *Training and expertise in a discipline related to device development, i.e., polymer engineering and processing, joining methods, metals, etc. *At least one year of experience in medical device industry, including QSR/ISO experience *Experience building and bench testing prototypes *Experience with CAD/SolidWorks *Experience using common shop tools such as drill press, milling machine, lathe *Excellent written, verbal and sketch/drawing communication skills Preferences: *Experience in the design and development of instruments used in the Medical Device Field is desired including laparoscopic and/or endoscopic surgical instruments, catheters, and other related mechanistic medical device platforms. *ISO, FDA or other regulated industry training and experience *Experience in product development from conception to release *Experience in mechanical design of medical devices *Previous experience in a “start-up” working environment Equipment to be used in

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