System Engineer

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