Design Engineer

Employer: Graphic Controls Acquisition Corp. dba Nissha Medical Technologies Requirements: Bachelors degree (or foreign equiv.) in Biomedical Engr., Mechanical Engr., Aeronautical Engr., or related Engineering Discipline + 3 years experience as a Design Engineer, Field Engineer, or a related engineering occupation. Experience is required and must include the following: Computer Engineering Analysis Software (CFD, FEA) to design, simulate and evaluate that the product solutions meet the customer requirements; Design verification (incl. tolerance and sensitivity analysis) to ensure product quality and reliability; Defining conditions for laboratory tests to verify product conformance to the customer requirements; Conducting technical investigations of irregular product outcomes to identify the root cause of issues and taking decisive actions to prevent their recurrence; Communicating complex technical concepts to a diverse range of stakeholders, from engineers to non-technical personnel, to facilitate understanding and collaboration across all levels of the organization; Designing and developing custom test methodologies to evaluate the performance of new technology.Duties: Lead development projects involving Medical Wearable Devices. Conceptualize innovative product solutions that meet customer requirements; may involve solid mechanics, fluid mechanics, thermodynamics, thermal mechanics, and electronics. Perform engineering analysis on new product concepts to evaluate whether they can meet product specifications, including the use of mathematical models and compliance with standards such as EN ISO 14971, EN 60601-1, ASTM D4169-16, ISO 10993-1, and ISO 20417. Develop detailed CAD designs of product solutions using SolidWorks while incorporating Design for Manufacturability and Assembly principles. Identify material selections most suitable for product applications. Create drawings and component specifications. Develop detailed drawings of components and assemblies identifying critical criteria required to meet quality standards. Identify and coordinate with suppliers capable of providing prototype and production components. Direct and oversee prototype development activities, including the review and evaluation of prototype performance data, to determine compliance with product specifications. Performance evaluations may include mechanical, electrical, and chemical characteristics. Create Engineering Studies documenting prototype performance, testing methodologies, test results, data analysis, and engineering conclusions. Collaborate with and distribute work among engineers with specialized skill sets to support efficient project execution and successful product development. Develop test methods used to verify that designs meet product specifications. Prepare protocols and reports supporting design verification activities, including statistical analyses utilizing software such as Minitab, Microsoft Excel, and Mathcad. Develop and approve procedures and work instructions for the assembly of product designs. Provide technical direction regarding production processing equipment requirements and manufacturability considerations, including custom fixture design and implementation. Create 3D CAD models and drawings in SolidWorks and identify materials approved for use in clean-room environments. Coordinate with external suppliers and internal stakeholders regarding the manufacture, assembly, qualification, and troubleshooting of fixtures and manufacturing aids. Research, evaluate, and recommend custom manufacturing processes appropriate for biomedical device applications. Design manufacturing fixtures and aids in SolidWorks and review installation and qualification results to ensure compliance with design requirements. Identify, document, and verify critical in-process and final acceptance quality criteria. Review and approve validation protocols, qualification activities, test results, and statistical analyses related to pr