System Engineer

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.

If you are a self driven, team player, have a can-do and problem-solving attitude, and want to work in a collaborative, multi-disciplinary workplace and impact the future of patient care in the ICU, then you may be the person we are looking for!

Main position duties:

Translate clinical and regulatory requirements into system and software specifications and architecture.
Define and develop software systems for medical devices, ensuring compliance with industry standards (e.g., IEC 62304, ISO 13485, Cyber security guidance).
Define robust, scalable, and maintainable software components and architecture for embedded systems, cloud platforms, and GUI applications.
Collaborate with mechanical, electrical, V&V and SQA engineers to ensure seamless integration of software and hardware.
Develop and execute system-level verification and validation protocols to meet regulatory requirements.
Conduct risk analyses to ensure System and software safety features are implemented and tested.
Create and maintain detailed technical System and SW documentation, including system & SW design specifications, SW test protocols, in compliance with regulatory standards.
Support regulatory submissions by providing technical documentation and participating in audits.
Work closely with cross-functional teams, including R&D, Product, clinical, quality assurance, and regulatory teams, to ensure alignment on project goals.
Provide technical mentorship to team members and contribute to knowledge sharing across departments.
Monitor software performance in deployed devices and recommend updates or improvements based on user feedback and post-market surveillance.
Stay updated on emerging technologies and methodologies relevant to medical devices.

Requirements:

Bachelor’s or Master’s degree in Software Engineering, Computer Science, Biomedical Engineering, or a related field.
3+ years of experience in software system engineering, preferably within the medical device industry.
Demonstrated experience with Class I, II, or III medical devices is highly desirable.
Demonstrated experience with Agile and/or Scrum methodology.
Demonstrated experience with writing SW requirements, specifications and user stories.
Knowledge of software development frameworks and tools (e.g., Git, Jenkins, Docker).
Experience with system modeling and design tools.
Familiarity with hardware-software integration and embedded systems.
Familiarity with GUI design tools.
Strong understanding of medical device standards (e.g., IEC 62304, ISO 14971).
Experience with FDA and/or MDR regulatory processes is a plus.
Strong written and verbal communication skills, particularly in cross-functional environments.
Ability to manage multiple projects and meet deadlines in a fast-paced, regulated environment.