R&D System Engineer

Who are we?

MeMed develops innovative diagnostic solutions that harness the body’s immune response to help physicians make better-informed treatment decisions. Our mission is to improve patient care by addressing critical clinical dilemmas with data-driven solutions.

Our flagship platform focuses on one of the most common medical encounters — the evaluation of fever — enabling differentiation between bacterial and viral infections at the point of care. (www.me-med.com).

The Role

We are seeking a strong Systems Engineer to join our R&D team in Haifa. This role is responsible for system-level architecture definition, requirements, interface definition, and risk management for a multidisciplinary IVD platform integrating hardware, software, and biological/chemical components. The Systems Engineer role includes cross-functional technical leadership and close collaboration with internal teams and external partners. The position reports to the Director of Systems Engineering.

Key Responsibilities

• Lead system-level requirements activities throughout the product lifecycle, including definition, decomposition, traceability, and change impact assessment.
• Own and maintain the risk management file and associated deliverables in accordance with ISO 14971.
• Develop and support system integration plans in collaboration with internal teams and external partners.
• Provide technical leadership for cross-disciplinary initiatives, including requirements definition, interface alignment, review of design outputs, and verification readiness.
• Support investigations of system issues and field complaints, including data analysis, root cause identification, and hands-on laboratory or technical work as required.
• Participate in defect management and resolution processes.
• Lead and participate in design reviews and design control activities
• Support audits and regulatory documentation as needed.
• Serve as the technical focal point for global third-party engineering partners
• Collaborate closely with R&D, QA/RA, Product Management, Operations, and external vendors to ensure timely, high-quality delivery.

Required Qualifications

• B.Sc. in one of the following fields: Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Computer Science, Physics, or a related discipline.
• 2–5 years of experience in systems engineering in multidisciplinary development environments.
• Experience in medical devices or regulated product development; IVD experience is an advantage.
• Demonstrated experience performing risk management activities in accordance with ISO 14971.
• Experience working with and coordinating external engineering partners in regulated development environments
• Strong analytical and problem-solving skills, including structured investigation and root cause analysis.
• Clear written and verbal communication skills in English; ability to work effectively across functions.

Preferred Qualifications

• M.Sc./M.E. in an engineering or science discipline.
• Experience working with external development partners, subcontractors, or suppliers.
• Experience with point-of-care diagnostics systems.
• Experience integrating chemistry or biology within engineering systems.
• Proficiency in scripting for data analysis and automation (e.g., Python).
• Familiarity with statistical analysis techniques for verification and investigations.
• Familiarity with relevant standards and regulations (e.g. FDA, IVDR, IEC 61010, IEC 60601)

Key Competencies

• Strong ownership mindset and attention to detail.
• Systems thinking mindset.
• Self-directed, able to manage multiple priorities.
• Ability to drive alignment and execution across functions without direct authority.