MECHANICAL DESIGNER

Lead sustenance activities (MLD) and remediation projects Lead and support CAPA investigations with RCA Support ongoing MDD and MDR regulatory compliance projects Support DHF (design history file) remediation for mechanical engineering deliverables which includes; defining strategy and planning, gap analysis, creating new and revising DHFs, reviewing and releasing DHFs DHFs accountability and responsibility for mechanical and mechatronic parts and sub systems (Gas path, valves, sensors (air, O2 and Pressure), manifold, patient interface, solenoid valves, filters, blowers, motors and enclosure) Review, mentor correctness and approve design documentation including requirements specification, design docs, engineering analysis & simulation studies, calculations, capture, test plans, test procedures, test records & reports Lead project team members to produce development plans and identify and mitigate development risks