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.