R&D Medical Device System Engineer
4 days ago
Roles and responsibilities
• Overall responsibility for system validation and verification procedures and NPI process.
• Define and conduct the system V&V procedures, including documentation (protocol & report).
• Support the regulatory validation processes.
• Define create, and run the required testing tools for the R&D and production line and conduct their
qualification process.
• Review and analyze requirements, specifications, and technical design documents.
• Perform software and system validation procedures and analyze bugs and errors found during tests
and document all found issues.
• Corrective and preventive action implementation.
• Collaborate with the software and algorithms developers, other R&D team members, QA, and
clinical teams, and subcontractors to enhance and improve system performance.
• Lead the Go to Manufacturing Engineering process and the manufacturing process.
Requirements:
• Experience of at least 2-3 years as a hands-on multi-disciplinary system engineer, including robotics
and optical modules integration and testing.
• Experience in quality assurance processes of development and manufacturing.
• Experience in testing embedded Linux software running on a device.
• Experience in writing and using Python for automated testing and calibration utilities.
• Hands-on experience in the assembly of electromechanical and motorized devices.
• Exceptional attention to the finest details.
• Good oral and written communication skills in English.
• Experience in writing technical documentation in English.
• Great team player and able to work efficiently with minimal supervision.
Advantages:
• BSc. In Electrical or Mechanical Engineering, and a higher degree in System Engineering.
• Understanding and using debug tools for C++-based embedded applications.
• Experience in testing medical devices.
Position:
• Reporting to the company SVP R&D.
• Full-time position.
• Flexible hours, but significant team face-to-face collaboration activities are required.
• A significant office and lab presence is required.
• Traveling to subcontractors outside of the company offices is required.
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