System Engineer - Israel

ART MEDICAL is a well-funded medical startup transforming ICU care through advanced technology and innovation.
Our smART+™ platform is an intelligent, sensor-based solution that optimizes nutrition delivery while reducing the risks of ventilator-associated pneumonia and malnutrition .Supported by clinical trials, we are setting a new standard in critical care by achieving nearly 100% feeding efficiency and reducing ICU stays by an average of 3.3 days.

We are looking for an experienced System Engineer for the System Engineering team at the R&D department at ART MEDICAL.
As a System Engineer, you will be part of a multidisciplinary group of system, hardware, firmware, software engineers maintaining and developing the current and future multidisciplinary systems.

Role & Responsibilities

• Convert user, product, and marketing requirements into practical system, subsystem level and software requirements.

• Manage system, sub system level and software requirements, specifications, and working parameters.

• Lead the risk management activities and documentation for the current platforms.

• Defining, planning, and leading system design and integration using a cross-disciplinary team of engineers.

• Lead problem solving and escalations from different stakeholders within and outside of the organization.

• Drive verification and validation activities for the current platform, including system , subsystem level and SW testing.

• Work in collaboration with different stakeholders in the company including R&D engineers, regulatory and quality, Product and SQA, to provide and maintain medical system compliance.

• Work with project and program managers to create and manage projects schedules and perform tasks breakdown.

Requirements

• BSc. in Bio-medical, Mechanical, Electrical, Computer science from a leading university; master’s degree is an advantage.

• 2-4 years of experience in development of multi-disciplinary medical devices is a must.

• 2-4 years of experience in a system engineering role is a must.

• Experience with risk management from a medical device company.

• Experience from multidisciplinary systems including HW, SW, mechanics, algorithms from medical device companies is an advantage.

• Knowledge and understanding of Medical Device Compliance and Medical standards (60601, 62304, 14971, 13485 etc.)

• Interpersonal skills and excellent teamwork capabilities.

• Experience with Medical Regulatory submissions.

• Experience with verification and validation activities and knowledge of testing methodologies.

• Good documentation skills and the ability to communicate effectively at all levels of the organization.