REQUIREMENTS / QUALIFICATIONS

• Related Degree in Product Design, Engineering, Human Factors, Psychology, Social Sciences related field or BioMed; Masters desirable.
• Experience in human factors engineering, with a focus on healthcare products (drug delivery, medical devices, digital health etc.). Other regulated sectors such as Aerospace or Defence will be considered.
• Experience of working within a Quality Management System meeting a regulatory standard (e.g., ISO 9001 and/or ISO 13485).
• Proficiency in relevant software tools for human factors research and analysis.
• Strong understanding of FDA and international regulations pertaining to human factors in medical device development (preferred).
• Passion for Human Factors / Human Centred Design / User Experience Design
  If you meet the criteria for Senior Human Factors Engineer and would like to be part of the journey, apply with a CV now. Your next career move could be just around the corner

Support Human Factors activities throughout the product development process including:

• Conduct comprehensive human factors research to identify user needs and preferences.
• Development of user profiles and use scenarios for each Quanta product.
• Identify user interface characteristics related to safety and potential use errors.
• Work collaboratively with other functions including marketing, engineering (system and software), clinical and regulatory to produce user-centred designs that meet user needs.
• Plan, conduct, and analyse usability testing sessions with end-users to assess the effectiveness and efficiency of Quanta products.
• Develop protocols, collect data, and provide recommendations for iterative design enhancements.
• Perform and maintain risk-based usability documentation (e.g., URRA) to understand user workflows and optimize device integration into clinical and home settings.
• Maintaining the Human Factors File and supporting regulatory submission by providing documentation and evidence of HFE activities.
• Manage and collaborate with external clinical partners and HF consultants.
• Ensure any targets set for the business relating to QMS KPI’s are monitored and met where appropriate (e.g., NC, CAPA, complaints resolution, self-training etc.).