Usability Engineer and Validation Lead

Responsibilities

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

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

Analyze post‑market data and identify usability issues.

Lead Usability FMEA (Failure Mode and Effects Analysis) activities.

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

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

Advise the design team on the usability aspects of design changes.

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

Support the development of user‑centered, safe‑to‑use UI and UX solutions.

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

Ensure 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 Randstad and work on assignment with Philips.

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