Cleanroom Preparation Technician

Description 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. The Cleanroom Preparation Technician is responsible for cleaning, inspecting, and preparing components for the assembly of Pi-Cardia medical devices in a controlled ISO 7 cleanroom environment. The role requires strict adherence to approved work instructions, quality standards, and documentation requirements to ensure compliance with company and regulatory requirements. Responsibilities Work in an ISO 7 cleanroom environment in accordance with cleanroom procedures and gowning requirements. Clean, inspect, and prepare components for medical device assembly according to approved work instructions. Accurately record activities and maintain documentation within the ERP system. Complete production records, preparation documentation, and related forms in compliance with quality system requirements. Identify and report quality issues, deviations, or nonconformities to the Production Manager. Maintain a clean, organized, and compliant work environment. Collaborate effectively with Production, Quality, and Operations teams. Requirements Previous experience working in an ISO 7 cleanroom environment, preferably in the medical device industry. Excellent fine motor skills and manual dexterity. Strong attention to detail, accuracy, and consistency. Ability to follow written procedures and maintain accurate documentation. Ability to work effectively as part of a team. Ability to perform routine production tasks that require prolonged standing and manual handling of components and materials.