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Occupational Qualification Standards: Diploma Biomedical Engineer, EstQF Level 7

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General Data
Use of Occupational Qualification Standard: An occupational qualification standard is a document which describes the set of skills, knowledge and attitudes, i.e. competence requirements, needed to successfully accomplish duties. Occupational qualification standards are used for compiling curricula and awarding qualifications.
Name in English: ET: Diplomeeritud biomeditsiinitehnikainsener, tase 7
EN: Diploma Biomedical Engineer, EstQF Level 7
Specialisations:
Partial occupational qualifications:
Valid from: 31.01.2020
Valid to: 05.11.2024
Occupational qualification standard version no.: 5
Versions:
Awarding Body: Andmed puuduvad
A Description of work
A.1 Description of work
Biomedical engineers work in health institutions, companies manufacturing, installing, maintaining and/or repairing medical devices, universities, test laboratories or other companies. The goal is to support the safe and high-quality functioning of contemporary medicine through engineering, medical ...physics and medical information technology applications.
The activities of Diploma Biomedical Engineer, EstQF Level 7 consist of medical physics, medical information technology or engineering works, incl. tasks related to the selection, installation, operation and repairing of medical devices.
The job entails operating in situations requiring an interdisciplinary approach both independently and in teams.
When working in health care institutions, the requirements in force in clinical environments must be observed. There is a possibility of contact with poisonous materials, infectious materials or ionising radiation, which requires the use of protective equipment in accordance with the nature of the job.

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A.2 Work units
A.2.1 Operating medical devices and systems
A.2.2 Improving medical devices and systems
Elective areas of work
A.2.3 Developing medical devices and systems
A.2.4 Management
A.3 Professional preparation
Diploma Biomedical Engineer, EstQF Level 7 has a professional Master's degree and sufficient work experience and has undergone further training.
A.4 Most common occupational titles
Medical engineering technologist, quality engineer, medical physicist, medical technology specialist, sales engineer, etc.
B Competency Requirements
B.1 Structure of occupation
Competency Requirements: Competences B.2 and B.3.1 - B.3.2 must be certified when applying for the qualification of Diploma Biomedical Engineer, EstQF Level 7.
Certification of optional competences B.3.3 and B.3.4 is not mandatory.
B.2 General skills of Diploma Biomedical Engineer, EstQF Level 7
1. In their activities, Authorised Biomedical Engineering Technologist, Level 7 relies on knowledge of engineering and medical physics:
a) general science (higher mathematics, higher physics, physiology and anatomy);
b) engineering (information technology, engineering graphics, electrical engineer...
ing, measuring technology and signal- and image-processing);
c) concepts of biomedical technology, research methods, potential applications, theoretical trends and topical issues;
d) principles of the organisation of medical technology and project management;
e) national and international performance, safety and environmental standards pertaining to operations and quality control;
f) principles of medical informatics.
2. They participate in team work, share all necessary and useful information with others and work to achieve the best joint result.
3. They create a positive communication environment and act in accordance with best practice in communication.
4. They make use of opportunities for self-improvement and keep informed of developments in professional technology.
5. They use at least Estonian and English at the B1 level (see Annex 1 – Language skills level descriptions).
6. They are guided by the professional ethics and code of conduct of engineers (see Annex 2).
7. They use the sub-skill of digital skills in their job: safety and content creation at the Basic user level and problem-solving, information-processing and communication at the Independent user level (see Annex 3 – Scale of self-assessment in digital competence).

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B.3 Competences
Mandatory competences
    Competence EstQF Level
B.3.1 Operating medical devices and systems 7

Performance indicators:
1. Follows all procedures for operating existing devices and systems, in line with quality standards.
2. Defines and solves engineering tasks using general and specialised expertise in engineering or medical physics.
3. Advises users on the operation of devices and systems and offers technical support.
B.3.2 Improving medical devices and systems 7

Performance indicators:
1. Analyses and optimises the performance of devices and systems and carries out compliance checks.
2. Identifies the need for changes, instigates the changes and implements them, bearing in mind technological developments.
3. Analyses the combined impact of system-wide risks and takes measures to manage them.
Optional Competences
Certification of optional competences B.3.3 and B.3.4 is not mandatory.
    Competence EstQF Level
B.3.3 Developing medical devices and systems 7

Performance indicators:
1. Devises, engineers and tests devices or their components.
2. Puts together the technology for manufacturing a device and the product's technical documentation.
B.3.4 Management 7

Performance indicators:
1. Initiates activities, manages their progress and goal-oriented development and makes management decisions.
2. Manages activities: Sets goals, guides and informs, supervises and controls the performance of employees, following the principles of management and organisational behaviour.
3. Develops and finds resources, monitors and analyses processes and organises problem-solving.
C General information and Annexes
Designation of occupational qualification standard in register: 24-31012020-01/5k
Field of occupational activity: Engineering, Manufacturing and Processing
Occupational Qualification Council: Engineering, Manufacturing and Processing
No. of decision of Occupational Qualification Council: 14
Date of decision of Occupational Qualification Council: 31.01.2020
EstQF level: 7
Reference to European Qualifications Framework (EQF): 7
Field: ENGINEERING, MANUFACTURING AND PROCESSING
Subfield: Engineering (technical and mechanical)
Occupation: Biomedical engineer
International Standard Classification of Occupations: 2 Professionals
21 Science and Engineering Professionals
214 Engineering Professionals (excluding Electrotechnology)
2149 Engineering Professionals Not Elsewhere Classified
ISCED Fields of Education and Training (ISCED-F 2013): 09 Health and welfare
091 Health
0912 Medicine
Statistical Classification of Economic Activities in the European Community (NACE): M PROFESSIONAL, SCIENTIFIC AND TECHNICAL ACTIVITIES
71 Architectural and engineering activities; technical testing and analysis
Annexes
Annex 1 Language skills level descriptions
Annex 2 Engineer's Professional Ethics and Code Of Conduct
Annex 3 Scale of self-assessment in digital competence
Occupational qualification standard compiled by
Name Organisation
Andres Kaalep SA Põhja-Eesti Regionaalhaigla
Andrus Aavik SA Tartu Ülikooli Kliinikum
Annika Mikola SA Põhja-Eesti Regionaalhaigla
Eduard Gerškevitš SA Põhja-Eesti Regionaalhaigla
Jaanus Lass AB Medical Group, Eesti Biomeditsiinitehnika ja Meditsiinifüüsika Ühing
Joosep Kepler SA Pärnu Haigla
Kalle Kepler Tartu Ülikool
Maie Bachmann Tallinna Tehnikaülikool
Marko Parve AS Ida-Tallinna Keskhaigla

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