System Engineer

HumanTouch Surgical (continuing Human Xtensions) is a cutting-edge startup developing a multidisciplinary product for minimally invasive surgery.  

We are seeking an experienced System Engineer to join our team and help shape the future of surgical innovation.  

Located in Netanya, we offer a dynamic, innovative environment where you can make a significant impact while working alongside dedicated professionals who are passionate about the future of medical technology. If you're ready for a new challenge and eager to grow, we'd love to hear from you! 

Responsibilities: 

• Collaborate effectively with cross-functional teams, including mechanics, electronics, and software specialists. 
• Lead the development of system- and sub-system-level requirements for a multidisciplinary medical device. 
• Participate in concept and design phases to define the system’s architecture. 
• Drive technical feasibility research to address unmet user needs. 
• Perform risk management activities throughout the product lifecycle. 
• Provide strategic technical leadership for system design, integration, verification, and validation processes. 
• Ensure system requirements are properly implemented, verified, and validated. 
• Contribute to establishing best engineering practices throughout the entire product development lifecycle. 
• Maintain safety and regulatory compliance in system design and documentation. 
• Lead root cause analysis for failure investigations. 
• Support regulatory submissions (FDA, EU) and participate in audits. 

Qualifications:  

• 5+ years of experience in the development of multi-disciplinary products 
• 2+ years of systems engineering experience in the medical device field 
• B.Sc / M.Sc Degree in mechanical or electrical engineering from a leading university 
• Master multidisciplinary system including mechanics, electronics, and software 
• Excellent knowledge of system lifecycle phases and design control processes 
• Familiar with systems engineering processes (e.g., requirements definition and risk assessment methodologies) 
• Proficiency in FDA Quality System Regulations, ISO 13485, and ISO 14971, with a strong emphasis on design controls. 
• Excellent documentation skills. 
• Able to collaborate across technical and non-technical disciplines. Good team player 
• Able to work in a start-up environment, with changing priorities and a high workload. Multi-Tasker  

Advantages 

• M.Sc in system engineering 
• Experience in medical software development 
• Experience in EMC and electrical safety certifications