Usability Engineer and Validation Lead

You are responsible for

• Delivering usability requirements and evidence throughout the product design and development process, ensuring the product release meets regulatory, customer, and business needs.

• Performing workflow analysis and user research to understand the context of use and elicit user needs and usability requirements.

• Analyzing post-market data and identifying usability issues.

• Leading Usability FMEA (Failure Mode and Effects Analysis) activities.

• Defining usability engineering plans and organizing usability activities in cooperation with business partners (e.g., project managers, clinical marketing).

• Planning and executing usability evaluations, ensuring critical findings are addressed in the design to guarantee a high level of UX, quality, and safety.

• Advising the design team on the usability aspects of design changes.

• Ensuring usability engineering is applied according to international standards (such as IEC 62366, FDA Guidance on Human Factors, and NMPA guidelines).

• Supporting the development of user-centered, safe-to-use UI and UX solutions.

• Leading Design Validation activities, including defining the product validation strategy, creating product validation plans/protocols, and executing product validation.

• Ensuring strong cooperation with other subject areas across the global organization.

Skills

• Highly independent and proactive mindset.

• Good communication, presentation, and leadership skills.

• Ability to “speak up” and effectively advocate for user needs and user experience.

• Ability to collaborate with multidisciplinary professionals and stakeholders from around the globe.

• Ability to write high-quality, formal technical documentation.

• Excellent written and verbal English communication skills.

Experience and Knowledge

• Master’s or PhD in Human Factors Engineering, Human-Computer Interaction (HCI), Cognitive Science, Product/Interaction Design, or a related technical academic background.

• Minimum 2-3 years of experience in usability engineering for medical devices, spanning from early-phase user need gathering to late-phase usability validation and post-market follow-up. This includes conducting task analysis, providing inputs to UI/UX designers, risk managers, and engineers, and performing/reporting usability evaluations.

• Proven experience with Design Validation, specifically in defining design validation strategies, creating product validation plans/protocols, and executing validation testing.

• Deep understanding of regulatory requirements for medical devices, including NMPA, FDA guidance, IEC 62366-1, FDA 21 CFR 820.30, EU MDR, ISO 13485, and ISO 14971.

• Expertise in human factors and interaction design, with proficiency in usability methodologies, processes, and standards. Good knowledge and understanding of cognitive and physical ergonomics principles.

• Strong project management abilities paired with excellent communication and collaboration skills.

• Preferred: Experience working effectively within multidisciplinary teams inside a complex, global company.

Contract

Initially, you will be contracted by the Randstad and work on assignment with Philips.