Sustaining Engineer
Job Description
Interface with Contract Engineers, Development Engineering, Production Engineering, Product Management, Regulatory, Clinical, Quality Engineering, Quality Assurance, Operations, sourced vendors and physicians as necessary to progress projects/tasks. Manage multiple project timelines, resources and responsibilities to achieve team, departmental, and company goals. Analyze risk using CEA and current FMEAs.
Identify
Follow Design Control procedures and comply with requirements of 21CFR820 Quality System Regulations, ISO 13485 and ISO 14971 as applicable. Identify user needs and develop into design input requirements