PROFESSIONAL SUMMARY Delivers creative and focused service by blending technical issues, including: installation, troubleshooting, calibration, inspection, preventive maintenance, repair, innovation, documentation and research of biomedical equipment. Provides qualitative and quantitative clinical management to serve organizational goals. * More than three years of experience in areas of quality assurance, manufacturing and clinical engineering * Knowledge of FDA design control guidelines, 510 (K) Pre-market notifications, IDE submissions * Strong knowledge of FDA 21CFR part 820, ISO 13485, ISO 14971, EU medical device directives. * Excellent experience in engineering fundamentals, project management and medical device technology * Formally trained on CAPA, FMEA and ISO13485 auditing at Jimma University * Understanding of engineering tools like Six Sigma, Design of Experiment and statistical process control * Extensive knowledge of human physiology, surgical procedures and operating room environment * Problem solving, analysis, and mathematics * Self-motivated, organized, proficient team player with excellent communication and interpersonal skills

Highlights:

• Biomedical Industry
• Audit
• C++ Programming Language
• Clinical Management
• Data Management
• Database
• Diagnostics
• Documentation