As a Usability Engineer & Validation Lead, you will serve as the critical bridge between clinical users (doctors, nurses, patients) and product engineering teams. Your mission is to ensure our medical devices are safe, intuitive, effective, and compliant with global regulatory standards throughout their lifecycle.
In this role, you will take full ownership of Usability Engineering and Design Validation activities across the product development lifecycle. You will perform workflow analyses, elicit critical user needs, lead risk management efforts (Usability FMEA), and collaborate with cross-functional teams (R&D, Clinical Marketing, Quality) to design user-centric interfaces. Additionally, you will define the overarching product validation strategy, author validation plans and protocols, and execute hands-on usability and validation evaluations. By generating robust technical evidence in compliance with FDA, EU MDR, and NMPA guidelines, you will ensure our products deliver an outstanding user experience while maintaining the highest standards of patient safety.
Functie-eisen
Education: Master’s or PhD degree in Human Factors Engineering, Human-Computer Interaction (HCI), Cognitive Science, Product/Interaction Design, or a related technical field.
Work Experience: Minimum 2 to 3 years of hands-on Usability Engineering experience specifically within the medical device industry across early concept phases, formative/summative usability testing, and post-market follow-up.
Design Validation: Proven track record in defining design validation strategies, writing product validation plans and protocols, and executing product validation.
Regulatory & Standard Mastery: Deep working knowledge and practical application of global medical device standards and regulations, including:
- IEC 62366-1 / FDA Guidance on Human Factors Engineering
- ISO 14971 (Risk Management / Usability FMEA)
- FDA 21 CFR 820.30, EU MDR, ISO 13485, and NMPA guidelines
Human Factors Expertise: Strong background in physical and cognitive ergonomics, interaction design, task analysis, and user research methodologies.
Language Proficiency: Excellent written and verbal communication skills in English, with demonstrated ability to produce high-quality formal technical documentation.
Competenties
- User Advocacy: Courageous voice for the end-user with the ability to articulate user needs and stand up for UX/safety priorities within engineering environments.
- Independence & Proactivity: High degree of self-motivation to drive complex usability and validation tasks autonomously from start to finish.
- Global Collaboration: Excellent interpersonal and leadership skills to partner effectively with cross-functional, multidisciplinary teams across international sites.
- Project & Stakeholder Management: Strong organizational ability to align usability timelines with broader project milestones, business partners, and regulatory deadlines.
- Analytical Thinking: Sharp analytical capability to translate complex clinical workflows and post-market data into actionable design improvements and risk control measures.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Randstad Professional. Heb jij een uniek talent? We ontmoeten je graag.