פורסם לפני 2 שעות לפי חסוי
"For a hi-tech company developing instruments for the beauty care sector, with offices in the North area
The ideal candidate possesses the ability to work both independently and as part of a team, with strong written and verbal communication skills. The person must be organized, detail oriented. The candidate ensures quality-engineering work and collaborates with experts in various disciplines (DQA, NPI, Sustain and Regulatory groups) in the integration, test, and evaluation of laser systems.
Provide hands-on engineering support for development, integration, and verification of laser systems
Ability to develop and execute V&V test plans, protocols, reports and test procedures to meet product requirements in accordance with internal company processes and international medical regulations
Verification planning, assembly, test preparation, and maintenance of engineering prototype medical systems.
Troubleshooting; optic, mechanic, hardware and software; test data analysis.
Support in preparation for medical compliance tests
Provide input into completion of product traceability analysis from marketing and product requirements through product risk mappings in relation to verification specifications
Uses Defect Tracking System, report and/or resolve product issues."
"Degree in Electrical / Software/Biomedical Engineering or similar related field or equivalent work experience. רפואה ופארמה
מהנדס ביו-רפואי | אלקטרוניקה וחומרה
5+ years of experience in Verification and Validation under Medical Device Regulations
Ability to create robust documentation and having a strong attention to detail
Experience in an FDA regulated environment that meet internal quality requirements and regulatory standards for Class II medical devices
Familiarity with FDA 21 DFR 820.30, ISO 14791, IEC 62304, IEC 60601
Familiarity with SW and System automated test tools - strong advantage
Strong Analytical and problem-solving skills"
משרה מספר 6814044