Required Senior System Engineer
Job Description Summary
As a Senior System Engineer, you will play a critical role in the design, development, integration, and verification of complex medical imaging systems. You will be responsible for translating clinical needs into technical requirements, ensuring the robust performance, safety, and regulatory compliance of our innovative healthcare solutions.
Job Responsibilities
Lead and participate in the full product lifecycle, from concept and requirements definition through design, development, testing, and deployment of medical imaging systems.
Translate high-level clinical and user requirements into detailed system and subsystem specifications, ensuring traceability and comprehensive coverage.
Perform complex system analysis, modeling, and simulation to optimize system performance, identify potential risks, and propose innovative solutions.
Collaborate closely with cross-functional teams including hardware, software, clinical, quality assurance, regulatory, and manufacturing engineers to ensure seamless integration and successful product delivery.
Define and execute system verification and validation plans, including test protocols, data analysis, and reporting, to ensure compliance with medical device regulations (e.g., FDA, CE).
Conduct root cause analysis for system-level issues, propose effective corrective actions, and drive their implementation.
Contribute to the continuous improvement of system engineering processes, tools, and methodologies within the organization.
Mentor junior engineers and provide technical guidance on complex system engineering challenges.
Stay abreast of industry trends, emerging technologies, and regulatory changes relevant to medical imaging systems.
Job Description Summary
As a Senior System Engineer, you will play a critical role in the design, development, integration, and verification of complex medical imaging systems. You will be responsible for translating clinical needs into technical requirements, ensuring the robust performance, safety, and regulatory compliance of our innovative healthcare solutions.
Job Responsibilities
Lead and participate in the full product lifecycle, from concept and requirements definition through design, development, testing, and deployment of medical imaging systems.
Translate high-level clinical and user requirements into detailed system and subsystem specifications, ensuring traceability and comprehensive coverage.
Perform complex system analysis, modeling, and simulation to optimize system performance, identify potential risks, and propose innovative solutions.
Collaborate closely with cross-functional teams including hardware, software, clinical, quality assurance, regulatory, and manufacturing engineers to ensure seamless integration and successful product delivery.
Define and execute system verification and validation plans, including test protocols, data analysis, and reporting, to ensure compliance with medical device regulations (e.g., FDA, CE).
Conduct root cause analysis for system-level issues, propose effective corrective actions, and drive their implementation.
Contribute to the continuous improvement of system engineering processes, tools, and methodologies within the organization.
Mentor junior engineers and provide technical guidance on complex system engineering challenges.
Stay abreast of industry trends, emerging technologies, and regulatory changes relevant to medical imaging systems.
Requirements:
Bachelor's or Master's degree in Electrical Engineering, Biomedical Engineering, or a related technical field.
5+ years of experience in system engineering, with a significant portion in the medical device industry (preferably imaging systems such as MRI, CT, X-ray, Ultrasound).
Proven experience in defining system requirements, architecture, and design for complex products.
Strong understanding of medical device regulations (e.g., IEC 60601, ISO 13485, FDA QSR, MDR).
Experience with risk management activities for medical devices.
Excellent analytical, problem-solving, and decision-making skills.
Strong communication and interpersonal skills, with the ability to effectively collaborate with diverse teams.
Ability to work independently and as part of a team in a fast-paced, dynamic environment.
Fluency in English and Hebrew (written and spoken) is required.
Bachelor's or Master's degree in Electrical Engineering, Biomedical Engineering, or a related technical field.
5+ years of experience in system engineering, with a significant portion in the medical device industry (preferably imaging systems such as MRI, CT, X-ray, Ultrasound).
Proven experience in defining system requirements, architecture, and design for complex products.
Strong understanding of medical device regulations (e.g., IEC 60601, ISO 13485, FDA QSR, MDR).
Experience with risk management activities for medical devices.
Excellent analytical, problem-solving, and decision-making skills.
Strong communication and interpersonal skills, with the ability to effectively collaborate with diverse teams.
Ability to work independently and as part of a team in a fast-paced, dynamic environment.
Fluency in English and Hebrew (written and spoken) is required.
This position is open to all candidates.
