Ali Homaida
Basingstoke
Summary
Experienced in Constructional Safety of medical devices from working for many years with global certification bodies (Test Houses) conducting compliance assessments and evaluation of medical devices and laboratory equipment to IEC 60601 and IEC 61010 series of standards respectively including Medical Software Lifecycle, Usability Engineering, Risk Management, and Home Healthcare Equipment.
This is combined with my biomedical engineering educational background and other experiences with the NHS Hospitals in England conducting In-Service Safety Testing, Technical Investigations, and Management of Medical Devices.
Overview
20
20
years of professional experience
7
7
years of post-secondary education
Work history
Senior Compliance Engineer
601 Consultancy Ltd, Active Medical Devices
Basingstoke
06.2022 - Current
- Providing consultancy services for medical devices manufacturers in constructional safety and the requirements of the relevant standards including IEC 60601 Series, ISO 14971, IEC 62304, IEC 82304, IEC 62366, and IEC 61010 Series
- Pre-Compliance evaluation - preliminary investigation on the design, markings, risk management file, usability file, IEC 62304 processes, and documentation to identify potential non-compliances (non-conformities) prior to product submission for certification assessments/testing
- Non-compliances resolution - supporting medical devices manufacturers in addressing non-compliances (non-conformities) received following product assessments/testing
- Provide training for medical devices manufacturers on the requirements of IEC 60601 Series, ISO 14971, IEC 62304, IEC 82304, and IEC 62366 including relevant processes that may be adopted in their technical files such as risk management process, software maintenance, software problem resolution, … etc
Senior Project Engineer
Underwriter Laboratories
Basingstoke
03.2020 - 06.2022
- Laboratories, IT and Audio, Electrical safety and compliance assessments of Medical Electrical Equipment / Systems against IEC/EN 60601-1 series of standards including physical testing
- Examination of risk management files against ISO 14971 in conjunction with the requirements of IEC/EN 60601-1 series, IEC 62304, and IEC 62366
- Assessment of medical device software (SaMD or part of medical device) to IEC 62304 including all the applicable requirements in the standard (development, risk management process, software maintenance, software problem resolution, and configuration management processes)
- Assessment of Medical devices for home use to IEC 60601-1-11
- Examination of usability engineering files to IEC 60601-1-6 and IEC 62366
- Electrical safety and compliance assessments of Laboratories Equipment / Systems against IEC/EN 61010 series of standards
- Compliance Assessment of IT & Audio equipment to IEC 60950 and IEC 62368
- Carrying out and supervising medical electrical safety testing and design assessment
- Identification of compliance requirements and strategies
- Project management activities
- Conduct technical meetings with customers and internal reviewers/certifiers
- Participation in workshops by providing insights into the testing process
- Participation in internal and external audits to demonstrate competence
- Preparation and creation of test methods.
Senior Engineer
TUV SUD Product Service UK, Active Medical Devices
Fareham
05.2015 - 03.2020
- Electrical safety and compliance assessments of Medical Electrical Equipment / Systems against IEC/EN 60601-1 series of standards including physical testing
- Examination of risk management files against ISO 14971 in conjunction with the requirements of IEC/EN 60601-1 series, IEC 62304, and IEC 62366
- Assessment of medical device software (SaMD or part of medical device) to IEC 62304 including all the applicable requirements in the standard (development, risk management process, software maintenance, software problem resolution, and configuration management processes)
- Assessment of Medical devices for home use to IEC 60601-1-11
- Examination of usability engineering files to IEC 60601-1-6 and IEC 62366
- Electrical safety and compliance assessments of Laboratories Equipment / Systems against the IEC/EN 61010 series of standards
- Compliance Assessment of IT & Audio equipment to IEC 60950 and IEC 62368
- Carrying out and supervising medical electrical safety testing and design assessment
- Identification of compliance requirements and strategies
- Project management activities
- Conduct technical meetings with customers and internal reviewers/certifiers
- Participation in workshops by providing insights into the testing process
- Participation in internal and external audits to demonstrate competence
- Preparation and creation of test methods.
Clinical Engineer
Portsmouth Hospitals NHS Trust
Portsmouth
08.2014 - 05.2015
- Provide medical devices management services including deployment, maintenance, calibration, and commissioning to a wide range of medical devices such as Electrosurgical units, Ventilators, Syringe drivers, Infusion Pumps, Defibrillators, Pacemakers, Pulse Oximeters, ECGs, Vital Signs Monitors, Operation Tables, and Nerve stimulators in addition to various diagnostic laboratories devices
- Provide training to medical staff on the use of new systems
- Support medical staff on the operation of medical devices when required
- Order the required spare parts from suppliers and manufacturers
- Provide technical opinion to medical staff on the quality of medical devices before purchasing
- Ensuring that the department's measurement devices are calibrated and performing the tasks correctly.
Clinical Engineer
Plymouth Hospitals NHS Trust
Plymouth
11.2012 - 08.2014
- Carrying out diagnostic and fault-finding tasks,
- Performed planned preventive and corrective maintenance, acceptance, performance, and safety checks on a wide range of medical devices Such as the above.
Field Service Engineer
Ministry of Health
09.2003 - 05.2005
- Commissioning of new medical devices & equipment
- Provide training to clinical staff in using and operating medical devices such as dialysis machines, infant incubators, ECGs & vital signs monitors
- Performs corrective maintenance and repair on a variety of medical devices.
Education
BEng with Honours - Biomedical Engineering
09.2010 - 07.2012
The main areas of study include Biomedical instrumentation, Electronic Circuit Design, Biomedical Optics, Biomedical Sensors & Instruments, Respiratory and Cardiovascular Measurements, Radiation Physics & Imaging, Medical Imaging Modalities, and Individual Project was conducted on Image Enhancement in Ultrasound Imaging.
BSc - Biomedical Engineering
09.1998 - 07.2003
This is a 5-year program that includes various medical and engineering subjects such as human physiology, anatomy, medical physics, electrical & electronics engineering, medical imaging, and programming languages.
Skills
- Electrical Safety Testing
- Fault Analysis
- Application of Risk Management to Medical Devices
- Installation/Commissioning
- Troubleshooting
- Creation of test methods & procedures
- Systems Engineering
- Bilingual in English and Arabic
Additional Information
- Awards - business excellence award 2018
Languages
Arabic
Native
English
Fluent
Certification
- Risk management applied to Medical Devices (ISO 14971:2019)
- Product Reviewer – 2017/745 UE regulation
- Introduction to Usability Engineering and IEC 62366-1 (2020)
- Project management
- ISO 9001:2015 lead auditor Training Course
- ISO 13485:2016 Lead Auditor Training
- Software Basic Training
- (PEMS, IEC 62304)
- Biocompatibility (ISO 1093-1) of Medical Devices
- Functional Safety – Medical Devices
- Risk Management (ISO 14791:2012)
- IEC 60601-1:2005+A1:2012
- Product Certification
- Usability Engineering – Medical Devices
- Electronic Product Safety Management
- Electronic Product Safety Design
- CE Marking
- V60 Ventilator
- Continuous Infusion Pumps
- Servicing of Nippy Ventilators
- Medical Equipment Technologies
- Servicing Dental equipment
- T34 Syringe Driver
- BodyGuard Syringe Driver
- HeartStart MRx Defibrillator
- Alaris Syringe Pump
- IVAC PCAM Syringe Pump
- Introduction to clinical Engineering
Timeline
Senior Compliance Engineer - 601 Consultancy Ltd, Active Medical Devices
06.2022 - Current
Senior Project Engineer - Underwriter Laboratories
03.2020 - 06.2022
Senior Engineer - TUV SUD Product Service UK, Active Medical Devices
05.2015 - 03.2020
Clinical Engineer - Portsmouth Hospitals NHS Trust
08.2014 - 05.2015
Clinical Engineer - Plymouth Hospitals NHS Trust
11.2012 - 08.2014
City University London - BEng with Honours, Biomedical Engineering
09.2010 - 07.2012
Field Service Engineer - Ministry of Health
09.2003 - 05.2005
Sudan University for Sciences & Technology - BSc, Biomedical Engineering
09.1998 - 07.2003
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