Quality Engineer

The Product Quality Engineer is responsible for providing quality engineering support to the manufacturing line and supporting finished goods release for structural heart implant, delivery, and robotic devices. Product and Operations Quality responsibilities include: Collaborate with R&D and Regulatory Affairs teams to ensure that biocompatibility requirements are met for medical devices. Provide guidance on sterilization processes and validations to ensure product safety and compliance. Facilitate sterilization activities including batch release, sterilization validation, and coordination with third party sterilizers. Oversee packaging validation activities to ensure product integrity and stability during storage and transportation.…