Usability Engineer & Validation Lead

About the Company  Join a global leader in healthcare technology, where innovation, safety, and user experience come together to improve patient outcomes. Within a highly regulated medical device environment, you will contribute to the development of safe, intuitive, and user-centered products used by healthcare professionals and patients worldwide.

Role Description  As a Usability Engineer & Validation Lead, you will be responsible for integrating human factors engineering and usability principles throughout the medical device development lifecycle. You will lead usability activities from early user research and requirements definition through design validation and post-market evaluation, ensuring products meet regulatory expectations, customer needs, and safety standards. Working closely with multidisciplinary global teams, you will influence product design decisions and ensure usability, quality, and patient safety are embedded into every stage of development.

Key Responsibilities   Lead usability engineering activities throughout the complete product development lifecycle
Perform workflow analysis, user research, task analysis, and context-of-use evaluations to define user needs and usability requirements
Develop usability engineering plans and coordinate activities with project managers, clinical marketing, engineering, and other stakeholders
Lead usability risk management activities, including Usability FMEA
Plan, execute, and document usability evaluations and ensure critical findings are incorporated into product improvements
Analyze post-market data to identify usability issues and improvement opportunities
Provide usability guidance to design teams regarding UI/UX solutions and design changes
Ensure compliance with usability engineering standards, including IEC 62366-1, FDA Human Factors Guidance, and applicable global regulations
Define product validation strategies, create validation plans and protocols, and execute design validation activities
Develop high-quality technical documentation to support regulatory submissions and product releases
Collaborate with multidisciplinary international teams across engineering, quality, regulatory, and product development
Requirements   Master's degree or PhD in Human Factors Engineering, Human-Computer Interaction (HCI), Cognitive Science, Product Design, Interaction Design, or a related field
Minimum 2–3 years of experience in usability engineering within medical devices
Proven experience across the full usability lifecycle, from user needs gathering through usability validation and post-market follow-up
Experience performing task analysis, usability evaluations, and usability validation studies
Experience supporting Design Validation, including validation strategies, protocols, execution, and reporting
Strong understanding of medical device regulations and standards, including: IEC 62366-1, FDA Human Factors Guidance, EU MDR, ISO 13485, ISO 14971, FDA 21 CFR 820.30,NMPA guidelines
Strong knowledge of human factors engineering, interaction design, cognitive ergonomics, and usability methodologies
Experience collaborating within multidisciplinary and international teams
Strong project management, communication, and stakeholder management skills
Ability to advocate for user needs and challenge design decisions when required
Excellent written and verbal English communication skills
58565

#J-18808-Ljbffr