Senior Usability Engineer @ AVENGA (Agencja Pracy, nr KRAZ: 8448)
(práce v Polsku)

Senior Usability Engineer @ AVENGA (Agencja Pracy, nr KRAZ: 8448)

Polsko

• Requirements
  
  
  • Experience in Usability Engineering for Medical Devices
  • Working knowledge of design controls and standards / guidelines like IEC 62366 and FDA "Applying Human Factors and Usability to Medical Devices"
  • Strong skills and experience in planning and conducting qualitative research methods, especially:
  • Usability testing
  • User interviews
  • Contextual inquiry / observation
  
  
• If working remotely - ability to visit Wrocław office about once a month (especially at the beginning, during onboarding to the project)
• Ability and readiness to travel to Hilden office few times a year for onboarding/research and to conduct formative evaluation
• Ability and readiness to travel to USA to conduct summative / formative evaluation, if required
• Understanding of software development process
• Ability to utilize own skills and experience in areas of product development other than software development, if needed
• Confidence, initiative, and independence in work
• Solid communication skills
• Proficient English language written & spoken (C1/C2)
• Team player and self-starter, able to perform with minimal supervision and capable to engage with variety of teams and roles in organization
• Passport (for UK/US travels)

Nice to have:

• 
  
  • Experience in UX research and UX design
  • Experience in working with complex systems
  • Analytical, conceptual, system thinking to help dive into and get around complex projects and problems
  • Solid skills and experience in UX Design
  • Knowledge and understanding of Medical Devices development processes
  • Experience in design and research for medical devices/software development
  • Experience in quantitative research methods (e.g. web analytics, surveys)
  • Experience in working in corporate environment / large organization
  
  

The role of a usability engineer in the medical device development process is critical, focusing on ensuring that medical devices are safe, effective, and user-friendly for their intended users, which may include clinicians, healthcare professionals, or patients themselves. Usability engineer plays a vital role in bridging the gap between medical device design and real-world use, ensuring that devices meet stringent safety and usability standards, comply with regulations.

Core reponsibilities of Usability Engineer, as a supporting role in development process, include:

• Risk identification and mitigation
• Usability evaluation / validation
• Ensuring compliance with relevant standards and preparing necessary documentation required for regulatory submissions
• Performing user research and developing use scenarios
• Cross-functional collaboration

The candidate must be willing to travel occasionally for a few days to Hilden / Manchester and (less frequently) to the USA.

,[Core tasks, Plan, prepare and carry out summative evaluation testing of new version of a medical device to comply with IEC-62366 and FDA Human Factors guidance., Engage with stakeholders to plan the study, Work with Risk Management team to select hazard-related scenarios for summative evaluation, Plan the evaluation tasks based on risk analysis, Conduct testing and analysis in laboratory environment in USA/Europe, Report findings and commend changes, Document evaluation results for regulatory purposes, Create/maintain Usability Engineering files and documentation, Plan, prepare and carry out research and formative evaluation activities on various stages of MDx product development process to support product design and help comply with IEC-62366 and FDA Human Factors guidance., Set goals, define metrics, select best research & evaluation methods for various research cases, Research to discover and understand users needs and problems, uncover opportunities and risks - interviews, contextual inquiry, observations etc., Conduct research activities to validate and refine initial product/software requirements, Conduct formative evaluations of design concepts - usability testing of software prototypes, interviews, feedback sessions, surveys, etc. (remote & on-site in Hilden, potentially US sites), Process, document and share/present research outcomes to provide valuable insights and support business, design and development decision making., Document formative and summative evaluation results for regulatory purposes to support creation and maintenance of Usability Engineering files and documentation., Review solution designs to help minimize usability risks / issues early, , Other tasks:, Establish Usability Engineering processes /ways of working / best practices, Form relationships within organization to utilize for research., Work closely with System team, business stakeholders, UX Designers, internal users.] Requirements: Tools: . Additionally: Sport subscription, Private healthcare, International projects, Free coffee, Bike parking, Free snacks, Free beverages, Modern office.

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businessIntelligence

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