דרושים System Engineer בנתניה

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