Process Quality Engineer

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