System Engineer

Eitan Medical is a fast-growing global medical device company, developing and manufacturing innovative drug delivery and infusion solutions across the continuum of care- from the hospital to the home. We are looking for an excellent Engineer to join the R&D system team.

• Analyze and manage risk analysis and assurance case reports for various company products
• Serve as risk analysis focal point across the organization
• Analyze and define system requirements and system development plan
• Develop algorithms for various system components
• Design and implement experiments for various projects
• Participate in departmental tasks that include problem solving and critical/root cause analysis
• Lead, process, and track R&D-driven Engineering Change Orders:
• Review and approvals of ECR/ECO
• Collaborate with stakeholders from all departments to efficiently manage and process changes in existing products Track and manage ECO implementations
• Track and manage of ECO closure
• Timely report ECO implementation status
• Education: B.Sc. in Biomedical Engineering or similar from an established university
• Job skills:
• Strong management skills, with experience leading cross-functional teams and complex engineering projects - must
• Strong communication skills, with the ability to lead technical initiatives
• Experience in a medical devices company with active multidisciplinary devices – advantage
• Knowledge and experience with regulatory requirements (FDA, ISO 13485, ISO 14971) - advantage
• Computer skills:
• Full control of all MS-Office applications
• Background in programming – advantage
• Language skills: Fluent English – written and spoken
• Personality:
• Friendly, analytical, motivated, meticulous, analytical mind, creative, expressive, excellent organizational and problem-solving skills

Direct Manager: System Manager