Process Quality Engineer

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 production lines • Experience in writing production and QC instructions and specifications • English at a very high level with an emphasis on writing • Good ability to read and understand drawings and specifications • HANDS-ON approach • Ability to lead processes • Multitasks ability • Takes responsibility • High self-learning capability • High interpersonal communication • Energetic, diligent • B.Sc. in Mechanical Engineering or another engineering discipline, with strong experience in mechanical product manufacturing