Master’s in Usability and Human Factors Engineering for Devices
Online master's programme of 1,900 hours in usability and human factors engineering for medical devices. 12 modules covering human error, the IEC 62366-1 framework, user research, use-related risk analysis, interface design, labelling, formative and summative evaluation, advanced measurement methods and usability across the life cycle, with an assigned technical tutor.
Master’s in Usability and Human Factors Engineering for Devices — studying from the United States
Health technology and biomechanics form a significant sector in the United States, anchored by medical device hubs in Minnesota, Massachusetts, California and New Jersey. Companies develop implants, diagnostic equipment, rehabilitation devices and wearable sensors under strict regulatory oversight. Engineers apply biomechanical modeling, human factors and operational safety analysis to improve device performance and worker well-being. Careers often involve close collaboration with clinicians and regulatory affairs teams.
Fees for the United States: US$7,730 (US Dollars), with instalments and employer sponsorship available.
Relevant bodies in the United States
Typical roles
Questions from the United States
Which professional bodies in the United States relate to this area, and does a SEIUM qualification make me a licensed engineer?
In the US, the Professional Engineer (PE) license is issued by state licensing boards and generally requires an ABET-accredited engineering degree, supervised experience, and passing the FE and PE exams. Biomedical and safety work also connects to bodies such as ASME and IEEE EMBS. A SEIUM qualification is a private qualification, not a state degree, and does not itself grant PE licensure. Recognition is decided by employers or the relevant licensing body.
Where do people with this training typically work in the United States?
Careers in this area commonly appear in medical device companies, wearable technology firms, hospitals and research institutions, and occupational safety departments in industrial employers. Hiring decisions depend on each employer's requirements and how they value private, non-accredited training, so you should check specific job postings and speak with target employers before enrolling.
Can I study this programme while working full time in the US?
The programmes are 100% online and taught in English, so you can study from home and no student visa is needed. Master's programmes total 1,900 hours, postgraduate diplomas 800 hours, and specialist courses 300 hours, so you should plan your weekly hours realistically. Fees are payable in instalments, and some employers offer sponsorship, which you can ask your employer about directly.
Take the controls.
Run a real engineering trade-off from this field. Move the sliders, watch the model react in real time and beat the challenge.
What you will be able to do
Apply the IEC 62366-1 usability engineering process.
Research the users and use contexts of medical devices.
Identify critical tasks and analyse use-related risks.
Design interfaces, alarms and labelling that prevent errors.
Plan and carry out formative evaluations.
Validate devices through rigorous summative studies.
Maintain the usability engineering file throughout the life cycle.
Who it's for
- Human factors engineers.
- Medical device usability specialists.
- Clinical interaction designers.
- User experience researchers.
- Usability regulatory consultants.
- Use-related risk managers.
- Engineering or science graduates looking to enter the medical device sector.
What you'll work with
- IEC 62366-1 (application of usability engineering)
- IEC/TR 62366-2 (guidance on usability engineering)
- Regulation (EU) 2017/745 (medical devices)
- ANSI/AAMI HE75 (human factors engineering)
- IEC 60601-1-6 (usability of medical electrical equipment)
- IEC 60601-1-8 (alarm systems)
- ISO 15223-1 (symbols for medical devices)
- ISO 14971 (risk management)
- Figma
- Tobii Pro Lab
- Morae
- Axure RP
- Dovetail
12 modules · 1900 h
1.1Human error and patient safety1.2Reason's Swiss cheese model1.3Error classification: slips, lapses and mistakes1.4Use-related incidents with devices1.5Use contexts: hospital, home and emergency1.6Professional and lay users1.7Cognitive load and attention1.8Environmental factors in the clinical setting1.9The benefit of usability engineering1.10Case study: an infusion pump incident
2.1IEC 62366-1 engineering process2.2IEC/TR 62366-2 application guidance2.3MDR requirements on safe use2.4FDA guidance Applying Human Factors (2016)2.5AAMI HE75 human factors design2.6IEC 60601-1-6 usability of medical electrical equipment2.7Minimum content of the usability engineering file2.8Interface with ISO 149712.9Differences between EU and FDA regulation2.10Workshop: structure of a usability engineering file
3.1Use specification3.2User profiles and personas3.3Contextual observation in the clinic3.4Interviews and focus groups3.5Hierarchical task analysis3.6Analysis of competitor devices3.7Review of the MAUDE incident database3.8Derived user requirements3.9Needs of users with disabilities3.10Practical exercise: task analysis of an autoinjector
4.1Hazard-related use scenarios4.2Critical tasks and their identification4.3PCA: perception, cognition and action4.4Use FMEA4.5Foreseeable errors and misuse4.6Design, protective and information controls4.7Prioritisation of use-related risks4.8Link to the risk management file4.9Reviewing the analysis after design changes4.10Laboratory: use FMEA of a glucometer
5.1Interaction design principles5.2Visual hierarchy and legibility5.3Physical controls and knobs5.4Touchscreens in clinical environments5.5Alarm design under IEC 60601-1-85.6Feedback, confirmations and error prevention5.7Iconography and ISO 15223-1 symbols5.8Design for gloved use and sterile environments5.9Clinical software design5.10Practical exercise: redesigning a monitor screen
6.1MDR labelling requirements6.2eIFU format and validation6.3Quick reference guides and training6.4Plain language and readability6.5Pictograms and comprehension6.6Labelling comprehension assessment6.7Packaging and opening6.8Patient labelling6.9Translation and cultural adaptation6.10Workshop: quick reference guide for a home-use device
7.1Objectives of formative evaluation7.2Heuristic evaluation using Nielsen and Zhang principles7.3Cognitive walkthroughs of critical tasks7.4Testing with low-fidelity prototypes7.5Testing with functional prototypes7.6Effectiveness, efficiency and satisfaction metrics7.7SUS scale and NASA-TLX7.8Design iteration7.9Formative report and redesign decisions7.10Practical exercise: heuristic evaluation of a clinical app
8.1Planning the summative study8.2Selection and size of user groups8.3Representative simulated environment8.4Prior training and training decay8.5Critical task protocol8.6Observation of errors and difficulties8.7Root cause interview8.8Analysis of results8.9Validation report and conclusions8.10Laboratory: simulation of a summative study
9.1Eye tracking of visual attention9.2Physiological measures of mental workload9.3High-fidelity clinical simulation9.4Virtual reality for testing9.5Video analysis and interaction logging9.6Remote and in-home studies9.7Mixed qualitative and quantitative methods9.8Statistics in usability studies9.9Ethics in user studies9.10Case study: eye tracking in a simulated operating theatre
10.1Infusion pumps and programming errors10.2Injection devices10.3Ventilation equipment10.4Monitors and central alarm stations10.5Self-testing devices10.6Surgical robotics consoles10.7Software and mobile apps10.8Drug-device combination products10.9Devices for paediatric use and carers10.10Case study: usability of an inhaler
11.1Integration into design control11.2Design changes and re-evaluation11.3Post-market use data11.4Use-related complaints11.5Accessibility and inclusion11.6Management of study providers11.7Audits of the usability file11.8A culture of user-centred design11.9Process effectiveness indicators11.10Practical exercise: analysis of use-related complaints
12.1Device and use context12.2User research12.3Use-related risk analysis12.4Interface design proposal12.5Iterative formative evaluations12.6Summative validation protocol12.7Usability engineering file12.8Post-market follow-up of use errors12.9Thesis report12.10Master's Thesis: defence before a panel
How you'll learn
Training is 100% online on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. There are no fixed timetables: you progress at your own pace within each intake, so the programme is compatible with full-time work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is Figma, Tobii Pro Lab, Morae, Axure RP and Dovetail, in free, academic or evaluation versions. Work is based on real procedures: usability studies with users in a simulated environment, heuristic evaluations of clinical interfaces and analysis of use-related incidents in public databases. Assessment is continuous by module, plus the final Master's Thesis.
Standards covered: IEC 62366-1, IEC/TR 62366-2, Regulation (EU) 2017/745, ANSI/AAMI HE75, IEC 60601-1-6, IEC 60601-1-8, ISO 15223-1, ISO 14971.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Where this takes you
Requirements
- University degree in engineering, science or architecture, or equivalent demonstrable professional experience.
- Internet connection and a computer capable of running the programme software.
- English sufficient to read technical standards.
Ready to start?
Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.
Frequently asked questions
The programme totals 1,900 hours over 12–14 months. You set your own pace within each intake, and your tutor helps you plan the workload around your job.
You work with Figma, Tobii Pro Lab, Morae, Axure RP and Dovetail, using free, academic or evaluation versions. Your tutor indicates the free alternative wherever one exists.
A SEIUM Institute diploma, awarded on passing the continuous assessment and the Master's Thesis. It is SEIUM's own qualification, not an official state degree; its recognition depends on the programme completed and the regulations of each country.
Yes. Modules passed in a course or postgraduate diploma in the same area are recognised in the higher programme. Ask about the recognition policy when you enrol.
A university degree in engineering, science or architecture (or equivalent professional experience), a computer able to run the programme software and English sufficient to read technical standards.
Start dates are set by SEIUM's faculty for each intake. Our admissions team will confirm the next available date when you apply.
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