We are seeking a highly skilled Usability Engineer with a minimum of 5 years of experience to advocate for user-centric design in our hearing aid solutions. The ideal candidate will apply design thinking principles to collect and analyze user insights, ensuring our products meet the highest usability standards while adhering to regulatory requirements. This role requires strong collaboration with Product Management, R&D Engineers, and expert customers to translate user feedback into actionable design improvements and ensure enhanced device safety, reliability, and satisfaction.

Key Responsibilities:

• Advocate for user-centric design to ensure our hearing aid solutions meet the highest usability standards through a holistic approach.
• Utilize design thinking principles to gather, analyze, and present user insights that guide product development, informed by both quantitative and qualitative research.
• Gather and analyze use errors and user insights with a focus on regulatory requirements to implement risk mitigations in the early design stages, enhancing device safety, reliability, and user satisfaction.
• Build strong relationships with diverse users, including expert customer HCPs, and translate their feedback into actionable design improvements through collaboration.
• Collaborate with Product Management and R&D Engineers to establish ergonomic, human factors, and usability-related requirements for new products.
• Develop and maintain comprehensive documentation for the Human Factors & Usability Engineering Process, including usability plans, specifications, risk analyses, protocols, reports, and engineering files.
• Participate in formative and summative usability testing in line with IEC 62366 standards, covering all stages from early product prototypes to final validation studies.
• Analyze complaints from on-market products to identify usability-related issues, ensuring continuous improvement in user satisfaction and safety.
• Ensure all documentation and processes adhere to regulatory guidelines, including FDA, IEC 62366, IEC 60601-1-6, IEC 60601-1-8, and ANSI/AAMI HE75, while fostering positive communication with all stakeholders.

Required Skills and Qualifications:

• Bachelor’s or Master’s degree in Usability Engineering, Industrial Design, or a related field.
• Minimum of 5 years of experience in Human Factors Engineering or Usability Engineering, preferably in the medical device industry.
• Strong understanding of human factors and usability principles, including design thinking methodologies.
• Experience in applying IEC 62366 standards and other relevant regulatory guidelines.
• Proficiency in gathering and analyzing both quantitative and qualitative user insights.
• Excellent communication and collaboration skills, with the ability to build strong relationships with diverse users and stakeholders.
• Strong problem-solving abilities and a detail-oriented approach to identifying and mitigating usability risks.
• Familiarity with FDA, IEC, and ANSI/AAMI standards related to human factors and usability in medical devices.