Overview
Process Quality Engineer Jobs in Rehovot, Center District, Israel at Pi-Cardia
Title: Process Quality Engineer
Company: Pi-Cardia
Location: Rehovot, Center District, Israel
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
