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.
עיקרי התפקיד
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
דרישות
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