• Design sub-assemblies to meet broad design goals, establish requirements and specification
• Use empirical, numerical and experimental analysis to analyze designs.
• Involved in test method and model development
• Identify and mitigate sub-assembly risks
• Support invention disclosures
• Work with internal departments and external vendors to obtain prototype parts and to understand their capabilities and limitations
• Support pre-clinical and clinical testing of devices
• Support design reviews and physician visits.
• Gain a detailed understanding of the developing clinical environment (i.e. current treatment methods, evolving clinical needs etc.).
• Gain a detailed understanding of the quality and regulatory requirements of SJM, FDA and ISO regulations, manage project within these requirements
• Gain a detailed understanding of overall schedule, manage time and task within schedule
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.