Responsibilities :
- 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
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