Process Quality Engineer
Description 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
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