Sr. Reliability Engineer

Job description

Position Description: Support engineering function within new product development for large development lifecycle of complex electro-mechanical & electronic medical devices. Design test methods and statistical process control procedures for achieving required levels of product reliability. Compiles and analyzes performance reports and process control statistics & investigates and analyzes relevant variables potentially affecting product and processes. Responsible for Medical Device Risk and deliverables to include Risk Analysis, Design, Use and Process Failure Mode Effects Analysis (xFMEAs), and Risk Assessment. Author reliability studies and evaluations of engineering design concepts and DOE constructs. Follow guidance within standards to include IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-2, IEC 62304, and IEC 62366. Navigate the complexities of various government and industry regulations to include FDA 21 CFR part 820, ISO 9001, ISO 13485, and ISO 14971. Coordinate Complaint and Product Failure Investigations, pre and post market root cause analysis, and CAPA. Design Control Deliverables to include Product Performance Specifications, Design Verification, Design Valida...