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R&D System Engineer
·Israel
On-siteFull-timeFrontend DevelopmentBiotechnology
Seeking a Systems Engineer to lead system-level architecture, requirements, and risk management for a multidisciplinary IVD platform integrating hardware, software, and biological components. The role involves cross-functional technical leadership and collaboration with global partners, reporting to the Director of Systems Engineering.
Responsibilities
- Lead system-level requirements activities including definition, decomposition, traceability, and change impact assessment throughout the product lifecycle.
- 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, design output review, and verification readiness.
- Support investigations of system issues and field complaints, including data analysis, root cause identification, and hands-on laboratory or technical work.
- 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.
Requirements
- B.Sc. in 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.
Nice to have
- 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).