Specific Duties and Responsibilities
• Fluently navigate quality management systems within scope and have general knowledge of quality systems beyond scope. * • Develop new processes for medical devices and components *
• Execute tasks independently and does not require assistance nor guidance. Recommends vetted solutions independently. *
• Thinks strategically within scope. *
• Create drawings for Production and Research and Development *
• Manage projects as a Project Leader within a multidisciplinary project team of peers independently. Leads other engineers independently. Influences other departments with guidance. *
• Provide technical support and perform tasks within multidisciplinary project team *
• Document manufacturing and production development process through lab notebooks, engineering protocols, and engineering reports *
• Identify and utilize vendors in the development of processes for Penumbra, Inc. products *
• Perform research and integrate new technologies into existing and future products and processes *
• Train engineers, technicians and assemblers in new processes and methods *
• Evaluate and troubleshoot problems to assess root cause and corrective action *
• Interpret and communicate test results *
• Solve practical problems encountered *
• Document findings and recommendations *
• Create and modify product design specifications *
• If in a supervisory position, select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans. *
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *
• Ensure other members of the department follow the QMS, regulations, standards, and procedures. *
• Perform other work-related duties as assigned. *Indicates an essential function of the role