![[Translate to English:] IEC 62366-1](/fileadmin/user_upload/IEC_62366-1.jpeg "[Translate to English:] IEC 62366-1")
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IEC 62366-1, the international standard for the safety-related performance of medical devices, is not an optional quality feature. Rather, it is an integral part of a development process that must be documented. In Europe, it serves as a technical reference framework within the context of the MDR (Medical Device Regulation, EU Regulation 2017/745), which governs the safety and performance requirements for medical devices. In the U.S., it is listed by the FDA (U.S. Food and Drug Administration) as a recognized consensus standard. The field of “human factors,” which examines how people interact safely and effectively with products and systems, is thus firmly at the center of regulatory focus.
However, the reality of the job market is different: Companies are looking for professionals who can not only design for usability but also document it in a risk-based manner and provide regulatory justification. This combination is rare in the job market. This article is aimed at companies seeking to fill such positions, as well as professionals who want to understand where their specialization fits within the field.
The current version of the IEC 62366-1 standard: 2015+A1:2020 (consolidated edition including the 2020 amendment) requires a documented process for the systematic analysis of users, the usage environment, the user interface (all elements through which the product is interacted with, such as displays, controls, labels, alarms, and instructions for use), and potential user errors. This is not a one-time test, but rather a continuous process that extends from the design phase through to summative evaluation. The latter is a final assessment that demonstrates that the product can be operated safely and effectively under realistic conditions.
An example illustrates the difference: In the case of an infusion pump (a device for the metered administration of fluids or medications), confusing units or misinterpreting an alarm are not mere convenience issues, but actual safety hazards. For companies, inadequate human factors documentation specifically leads to regulatory inquiries, CAPA measures (Corrective and Preventive Actions, i.e., documented corrective and preventive measures in quality management), and product liability risks.
Candidates should not only possess general UX expertise but also be proficient in integrating user research, risk analysis, and regulatory documentation.
There is no single degree program that directly leads to the role of usability engineer as defined by IEC 62366-1. Typical academic backgrounds include HCI (Human-Computer Interaction), psychology, ergonomics, medical technology, or regulatory affairs. The competency profile combines methodological knowledge with expertise in standards, particularly IEC 62366-1, ISO 14971 (the international standard for risk management of medical devices), and ISO 13485 (the standard for quality management systems in the medical device industry), as well as the ability to prepare regulatory documentation. This combination is rarely found in its entirety.
In addition, the pharmaceutical, digital health, automotive, and aviation industries are all competing for similar profiles. Those with experience in safety-critical systems are in high demand across multiple industries. In our consulting practice, we regularly observe that hiring efforts fail not because of market conditions, but due to undifferentiated job descriptions that bundle UX, human factors, and regulatory affairs. For applicants, the rule is: Specialization creates a strong negotiating position when demonstrable project experience underpins knowledge of the relevant standards.
A more precise job description is needed: It is unrealistic to expect one person to simultaneously plan studies, facilitate meetings, conduct risk analyses, be responsible for regulatory documentation, and advise multiple product teams. Such a description deters qualified candidates because it does not outline a clearly defined role.
Combine “make” and “buy”: It is structurally more sustainable to develop a key internal expert and strategically utilize external support for project peaks and independent validations than to outsource everything.
Take retention seriously: In our industries, we observe that specialists often leave organizations not because of the work itself, but because their insights aren’t incorporated into product decisions or because they lack career paths. Employee retention is therefore not purely an HR issue, but a strategic one.
Align staffing plans with the pipeline: The search should be guided by the product pipeline and should not begin only when validation is imminent.
Certificates, such as those from IEC 62366 training courses or from RAPS (Regulatory Affairs Professionals Society, an international professional organization for regulatory affairs experts), demonstrate foundational knowledge but not operational project maturity. What matters is the big picture: Did the person plan and facilitate the studies themselves? Did they translate the results into risk analyses? Did they create a complete usability engineering file, i.e., a documentation folder that compiles all standards-compliant evidence regarding a product’s usability?
Candidates stand out through anonymized case studies that demonstrate how they think, not just which methods they know. For companies, case-based interview questions are more revealing than standard, rule-based questions. Anyone who answers every question with a one-size-fits-all approach may not have understood the risk-based nature of the process. Competence is demonstrated by the quality of the documentation and the ability to translate study results into design decisions.
IEC 62366-1 is not a niche topic limited to specific product categories. It is an integral part of development processes that meet regulatory requirements, both in Europe and the United States. The demand for specialists who can combine user research, risk analysis, and regulatory evidence can’t be met in the short term by existing educational systems.
For companies, this means they should proactively recruit now and systematically build internal expertise, rather than waiting until validation is imminent. For job seekers, this specialization is future-proof. Those who combine project experience with regulatory judgment are positioning themselves in a market that is looking for precisely this combination. The strongest profiles emerge where human behavior, technical design, clinical context, and regulatory evidence-based reasoning come together in a coherent process.
If you are looking for qualified and motivated specialists and executives for your company, we can support you with our specialized network. Especially when it comes to highly specialized roles in the fields of human factors and usability engineering, at the intersection of user research, risk management, and regulatory affairs, we know what truly matters in the selection process. For over 15 years, the recruitment consultants at BESTMINDS have been filling vacancies in the medical technology, healthcare, life sciences / pharma, energy / utility, and IT / media sectors with a wealth of expertise and dedication. We’ll find the right candidates for you in a fair, loyal, and discreet manner. Contact us for a no-obligation initial consultation so we can fill your vacancies quickly and effectively.
