Manage the Design Control and product design and change Risk Management processes for sterile catheter-, software-, electromechanical-based medical device product families. Provide Quality Engineering support for Product Development Projects throughout all phases of Design Controls (Concept to Launch) and Design Risk Management.
This is a key contributor position working closely with R&D, Operations, Commercial, Regulatory and Operations Quality to ensure compliance with AVI's QMS and FDA QMSR requirements, with particular focus on Design Controls and Risk Management.
