Cleanroom Preparation Technician - 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.

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.

• 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.