About Pi-Cardia Pi-Cardia is a growth-stage medical device company focused on developing innovative solutions for structural heart disease. Founded in Israel, with expanding operations in the United States, Pi-Cardia combines clinical excellence, technological innovation, and entrepreneurial agility. Our team works closely with leading physicians and global partners to bring meaningful, life-improving therapies to patients worldwide. We are building a high-performance organization that balances rapid growth with operational discipline, regulatory excellence, and a strong people-first culture. Position Overview The Process Quality Engineer is responsible for managing production deviations, leading root-cause investigations, and coordinating engineering changes to ensure product quality and compliance. The role includes developing technical documentation, validating processes and equipment, and providing ongoing support across R&D, production, QC, and subcontractors. Additionally, the position drives continuous improvement initiatives to streamline production lines and enhance operational efficiency. Responsibilities - The Quality Engineer will be responsible for handling deviations in production and managing the revision processes - Opening exceptions for malfunctions in production In-house, in the QC, or at sub-contractors - Investigating abnormalities in production and locating the route cause - Opening and managing engineering changes - Writing product/production files - Writing production/testing instructions and defining technical specifications - Validation of production processes and equipment - Ongoing product support while communicating with R&D, logistics, marketing, production, and subcontractors - Streamlining the production lines (by new technologies, reducing costs, reducing times, etc.) REQUIREMENTS - 2 - 4 years of experience as an engineer preferably in medical devices - Knowledge of production technologies and experience working with produc
