Mechanical Quality Engineer

Pi-Cardia is a Medical Device Company that develops devices in the Cardiology field. The company offers treatment options for structural heart disease that provide safe, effective, and affordable non-implant-based catheter solutions and is in the advanced stages of clinical trials.

Job description:

• 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.)
• Subordination to the Vice President of Operations

Requirements:

• Education - Engineering, biotechnology, materials, biomedicine, preference for machines
• 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