Research and Development Engineer

The Company  A global medical technology organization focuses on developing innovative healthcare solutions that improve patient outcomes and user experiences. The company operates in a highly regulated environment and emphasizes quality, safety, human factors engineering, and regulatory compliance throughout the product lifecycle.
About the Role  We are seeking Usability Engineer and Validation Lead to drive usability engineering activities and design validation efforts for medical device products. This role is responsible for ensuring products meet regulatory requirements, user needs, and business objectives through human factors engineering, usability evaluations, risk management, and validation strategies. You will collaborate with multidisciplinary teams to deliver safe, effective, and user centered medical devices.
Responsibilities   Deliver usability requirements and usability evidence throughout product development
Conduct workflow analysis, user research, task analysis, and contextual inquiry
Define and manage usability engineering plans and activities
Analyze post market data to identify usability issues and opportunities
Lead usability FMEA activities
Plan, execute, and document usability evaluations
Ensure usability findings are incorporated into product design
Advise design teams on usability related design changes
Ensure compliance with IEC 62366, FDA Human Factors guidance, NMPA requirements, and related standards
Support development of user centered UI and UX solutions
Define design validation strategies and validation requirements
Create validation plans, protocols, and reports
Execute product validation activities
Collaborate across engineering, clinical, quality, regulatory, and marketing teams
Maintain high quality technical and regulatory documentation
Requirements   Master's or PhD in Human Factors Engineering, Human Computer Interaction, Cognitive Science, Product Design, Interaction Design, or related field
Minimum 2 to 3 years of usability engineering experience within medical devices
Experience conducting usability studies, task analysis, user research, and usability validation
Experience defining and executing design validation strategies and protocols
Strong knowledge of IEC 62366 1, FDA Human Factors Guidance, FDA 21 CFR 820.30, EU MDR, ISO 13485, and ISO 14971
Expertise in human factors, engineering and interaction design
Excellent project management and organizational skills
Strong communication, presentation, and leadership skills

Experience of collaborating in multidisciplinary and global teams
Excellent written and verbal English communication skills
Other Information  58582

#J-18808-Ljbffr