Kenda Daghash
Summary
A highly motivated biomedical engineer with a BS in Biomedical Engineering and over 3 years of experience working with advanced medical technologies, including PET systems and the Xeleris workstation. Proficient in complaint handling, clinical product surveillance, and regulatory compliance. Adept at problem-solving and committed to improving patient outcomes through the application of biomedical solutions.
Overview
4
4
years of professional experience
Work History
Lead Specialist, Product Surveillance, Clinical NM
GE HealthCare
05.2023 - Current
- Lead complaint handling processes for multiple medical devices, ensuring compliance with global quality procedures.
- Worked closely with engineering teams to diagnose and address technical issues, providing real-time feedback on device performance and functionality.
- Ensured that all complaint handling and post-market surveillance activities complied with regulatory requirements (FDA, EU MDR) and internal quality standards.
- Participated in internal audits for product safety and quality assurance, identifying areas for improvement and ensuring compliance with industry regulations.
- Enhanced team productivity by implementing efficient work processes and streamlining operations.
Verification Engineer
GE HealthCare
01.2021 - 06.2023
- Performed verification testing for PET systems and Xeleris workstation to ensure product functionality and safety.
- Collaborated with cross-functional teams to streamline testing processes and address product concerns.
- Enhanced team productivity with well-documented test plans and reusable test environments.
- Implemented coverage-driven verification techniques for improved test effectiveness and resource allocation.
- Developed comprehensive test cases to validate design specifications, increasing overall product quality.
Education
Bachelor of Science - BS, Biomedical Engineering
Technion - Israel Institute of Technology
Haifa, Israel08.2019
Skills
- Medical Device Verification & Validation
- Complaint Handling and Regulatory Compliance (GQP standards)
- Root Cause Analysis and Troubleshooting
- Cross-functional Team Collaboration
- Quality Assurance and Internal Auditing
- Data Analysis & Reporting
- Familiar with FDA and EU medical device regulations
Additional Information
Awards and Recognitions
- Award from the DMI 4.0 Program Team
Received for outstanding contributions to project success, ownership, and accountability. - Two Awards as Lead Specialist, Product Surveillance, Clinical NM
Recognized for excellence in complaint handling and quality assurance initiatives.
Languages
Arabic
Native language
English
Proficient
C2
Hebrew
Proficient
C2
Timeline
Lead Specialist, Product Surveillance, Clinical NM
GE HealthCare
05.2023 - Current
Verification Engineer
GE HealthCare
01.2021 - 06.2023
Bachelor of Science - BS, Biomedical Engineering
Technion - Israel Institute of Technology
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