Responsible for component development of electromechanical systems for the diagnosis and treatment of cardiovascular disease.
Technology development, product design and development, test of materials or products, preparation of specifications, process capability studies, validations, process documentation, research investigation (animal and clinical studies), and report preparation.
Provides design support to manufacturing and sustaining. Recommends and implements modifications and corrective actions when appropriate.
Carries out projects with high degree of creativity, utilizing a cross-functional team of engineers and scientists on complex projects.
Drafting of test plans and protocols used for verification and validation.
Perform verification testing as required.
Assemble prototypes and develop initial manufacturing instructions.
Partner with manufacturing to investigate and solve critical production process problems as needed
Perform product and process risk analysis and statistical analysis of test data
Complete returned product complaint investigations as needed
Maintain R&D calibration records and team hardware as required.
Qualifications:
Associates or greater in related engineering degree.
0-2 years of medical device development experience
Experience with 3D CAD and Drafting (SolidWorks)
Experience with design for manufacturing and process development is preferred
Experience with component design of machined parts is preferred
Experience with component design of sheet metal parts is preferred
Experience with component design of molded parts is preferred
Experience with mechanical design of electromechanical or controls systems is preferred
Ability to independently organize/align project tasks with department priorities