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