Functieomschrijving
Functieomschrijving
- You perform workflow analysis and user research to understand the context of use and define user needs and usability requirements.
- You write usability engineering plans and organise usability activities together with project managers, clinical marketing and other partners.
- You plan and run usability evaluations and make sure critical findings are resolved in the design.
- You lead the Usability FMEA and analyse post-market data to identify usability issues.
- You advise the design team on the usability impact of design changes and support user-centred, safe-to-use UI/UX solutions.
- You deliver the usability evidence for product releases that meets regulatory, customer and business needs.
- You ensure usability engineering is applied according to international standards such as IEC 62366, FDA Human Factors guidance and NMPA guidelines.
- You maintain good cooperation with other disciplines within the organisation.
Functie-eisen
Must-haves
- A master's degree in human factors engineering, HCI, cognitive science, product/interaction design or a related field.
- At least 3 years of experience in usability engineering, from gathering user needs to usability validation, preferably for medical devices.
- Hands-on experience with task analysis and with performing and reporting usability evaluations.
- Good knowledge of usability regulations for medical devices: IEC 62366-1, FDA guidance and NMPA.
- Understanding of quality management systems (QMS), risk management and cognitive ergonomics.
- The ability to write high-quality formal documentation.
- Excellent English, written and spoken.
Nice-to-haves
- Knowledge of the healthcare domain and clinical workflows in hospitals.
- Knowledge of physical ergonomics.
- Experience in multidisciplinary teams within a complex global company.
- Strong communication, presentation, leadership and project management skills; independent and proactive with a customer-first attitude.
Arbeidsvoorwaarden
- A gross monthly salary between € 4,500 and € 6,000, depending on education and experience.
- A permanent contract through secondment with a leading health technology company.
- Meaningful work that directly improves patient safety and the daily work of physicians.
- Always a permanent job; no temporary projects.
- After a pre-agreed period, a transfer to the client is possible.
- An extensive package of secondary employment conditions.
- Plenty of opportunities for personal and professional development.