Senior Biomedical Engineer – ReliefWeb

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USA
Additional Job Description
The Senior Biomedical Advisor is responsible for providing senior-level technical and operational advice across FHI 360, serving as a lead technical advisor and providing assistance to field programs in the area of COVID-19 biomedical services. This position will provide assistance in the following four major areas;
Build national and subnational level capacity in installation, repair and maintenance of the medical equipment 2) Contribute to the development or revision of national strategies, guidelines, tools and resources for bio-medical equipment for management of COVID-19 3) Lead implementation of surveys and rapid assessments in collaboration with local partners 4) Provide global scientific leadership in the maintenance of COVID-19 related equipment and infrastructure. This position reports to the Epic COVID-19 Technical Director.
Accountabilities:
Provide technical assistance to developing countries in the field of bio-medical engineering with a focus on improving quality of services for COVID-19 patients.
Lead development of rapid assessment protocols, its implementation, data collection, analysis and its presentation to national and subnational governments.
Support development or revision of national regulations, strategies and implementation plans to improve maintenance of equipment required for COVID-19 case management.
Identify and prioritize items that play a vital role in the delivery of medical oxygen to COVID-19 patients and provide assistance to countries to build capacity at national and regional level to maintain these items.
Provide hands-on equipment preventive maintenance training, including but not limited, analytical instrument qualification and validation as per the requirement of ISO/IEC and WHO Good Practices for Pharmaceutical Quality Control
Develop analytical instrument, preventive maintenance protocols and procedures (SOPs) to be used and applied at the national and sub-national levels.
Work with ministries of health and other national biomedical engineering groups to develop a list of recommended spare parts and source.
Build capacity of biomedical technicians in target hospitals and health facilities on preventive maintenance, installation, and repair of equipment.
Develop tools and check lists and train local biomedical technical to continuously supervise equipment such as PSA/VSA plants, cylinders, oxygen tanks, oxygen transfer pipes, oxygen concentrators, and other oxygen delivery equipment.
Collaborate with country offices, public and private, national, and international partners on international programs and strategies to strengthen biomedical engineering services.
Provide technical mentorship on the implementation of systems for quality management and biosafety of medical devices, and biomedical equipment in the target countries, including support for the development of work-plans and budgetary proposals.
Support development of accurate records of maintenance activities by biomedical technicians in developing countries.
Contribute to the establishment of communities of practice and regional networks on biomedical engineering services to promote sharing of standard methodologies and learning.
Monitor, evaluate and report on progress in improving access to quality biomedical engineering systems and services in the region, using standardized methodologies and tools, and propose strategies for improving universal access to services.
Work closely with other Epic team members to ensure technical work plans are being implemented in a timely and technically sound manner, and productively use.
Perform other related responsibilities as assigned, including replacing and backstopping for others as the need arises.
collaboration with key government and other stakeholders and partners.
Required Minimum Education:
Master’s in biomedical engineering or degree related with health technological products.
At least 12 years of proven experience in regulation of health technological products with a focus on medical device’s registration, import/export control, vigilance of the health technology product or equipment
Considerable experience in the development of standard technical specifications, manuals for medical devices, quality testing references, assessment of technical files prior to listing and performance of quality audits for medical devices manufacturers.
Experience in the development of training materials and, coordinating and implementing training events!
Experience in development of manuals for health technology products including medical devices materials
Experience in developing guidelines and SOPs for classification and listing medical devices
Prior work experience in a non-governmental organization (NGO), government agency, or private organization. International or Domestic (US) Program Development or Program management preferred.
Typical Physical Demands:
Typical office environment.
Ability to spend long hours looking at a computer screen and doing repetitive work on a keyboard.
Ability to sit or stand for periods of time.
Ability to move 5 – 25 lbs
Technology to be Used:
Travel Requirements:
https://fhi.wd1.myworkdayjobs.com/FHI_360_External_Career_Portal/job/USA-Any/Senior-Biomedical-Advisor_Requisition-2021202249
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