- Evaluate and maintain the safety, efficiency, and effectiveness of custom CAD/CAM milling machine and 3D body and foot scan
- Quality control and project management
- Organizing patient database
- Processing biomedical tenders
senior biomedical engineer
- Consult or negotiate with clients to prepare marketing specifications.
- Plan, direct, or coordinate survey work with other maintenance activities.
- Administer highway planning, calibration, or maintenance.
- Perform Plan Preventive Maintenance, troubleshooting, breakdown and repairing.
- Volunteer Internship in the Biomedical department working in both the administrative and technical aspects
- Administered, cataloged and organized biomedical assets for JCI audit
- Facilitated in management and procurement of biomedical assets
- Introduced to CSSD and ICU medical equipment and processes
junior biomedical engineer
- Evaluated in hospitals, nursing homes and clinical environments.
- Performed repairs, calibration and preventative maintenance of medical instrumentations.
- Serviced various equipment and apparatus. Patient monitors, Defibrillator, Diagnostic equipments etc..
- Support service at Hospital UiTM Kampus Sungai Buloh.
biomedical engineer (raqa)
- Underwent training on basic principles and processes followed in different departments of an effective Quality Management System. Expertise in creating Clinical Evaluation Report (CER) for CE Marking of class I and II medical devices along with preparing work Instruction (WI) and training materials on how to create a CER.
- Coordinating, conducting regular RA/QA meetings and leading a Project to establish a Quality Management System as per the ISO 13485, CE Mark and FDA registration requirements.
- Worked on Risk Analysis documents, i.e. review and customization of Risk Management Standard Operating Procedure (SOP), Risk management File, Risk Management Plan, Risk Analysis Report, ER Checklist, Risk-Benefit Analysis (RBA), etc. in compliance with ISO 14971:2012.
- Worked extensively on conducting Predicate Search for Subject Devices undergoing FDA 510(k) submissions. My work focused around corresponding and closely working with clients in identifying predicates and doing a thorough evaluation of the different predicates by taking account of the device-specific product codes, product technological features, etc.
- Worked on product development document like System Requirements Specification (SYRS) document, checking and maintaining their compliance with all international standards applicable to the respective medical device. Also, worked in creating medical device specific intended use, indications for use and device description as per client specifications and requirements of their respective device.
- Worked towards Pre-Submission of class II first in use innovative medical device and compilation of documents required for the Pre-Sub process. Advice to the client regarding the Pre-Submission Process as per the FDA Guidance and worked towards and analyzed the various non-clinical testing’s to be carried out for a medical device undergoing FDA submissions as per device specific ISO standards.
- Assisted and advised clients with a review of Biocompatibility Test Reports against all applicable Regulatory standards.