Operations

Validation Expert

Tel Aviv

Description:

Vectorious has developed the world’s first in-heart microcomputer and is on a mission to transform heart failure treatment. As part of our first in-human clinical study, we have successfully implanted our sensory device in patients across Europe, while demonstrating a huge potential in helping millions of people living with heart failure to take control and manage their disease. As an increasingly growing company we’ve been accepted to FDA’s prestige Breakthrough Device Designation program.

We are looking for a talented Validation Engineer to join our Operations team

What will you do?:

1. Establish Performance and Quality Criteria- develop criteria to evaluate the effectiveness of processes.

2. Design and Execute Testing Protocols:

• Create and implement testing procedures.
• Analyze data from validation tests and document results.

3. Evaluate Production Systems and Processes:

• Assess the functionality, safety, and performance of systems.
• Identify areas for improvement and recommend corrective actions.

4. Troubleshoot Issues:

• Investigate and resolve any system-related issues.
• Collaborate with engineers and technicians to address challenges.

What do you need to bring with you?:

• Experience: 7+ years in validation engineering, development, or a related role, with 3+ years in a senior or leadership position within the medical device industry (Class II/III).
• Validation & Quality Assurance: Deep expertise in validation processes (IQ, OQ, PQ), PFMEA, test method validation, and quality management systems. Proven ability to lead and approve projects with a focus on process capability, risk management, and continuous improvement.
• Technical Background: Strong product development or engineering foundation, with additional experience in design and quality roles being a significant plus.
• Statistical & Analytical Skills: Proficient in statistical analysis tools ) JMP, Minitab) and capable of driving decisions through data analysis.
• Leadership & Collaboration: Demonstrated leadership in guiding multidisciplinary teams, with excellent problem-solving and communication skills to work effectively across functions.
• Education: Bachelor’s or Master’s degree in Materials, Mechanical, Electrical Engineering, or a related field. Advanced degrees or relevant certifications are a plus.