Cleanroom Preparation Technician

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 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.