Senior Human Factors Engineer - Warwick, Warwickshire, United Kingdom - Quanta Dialysis Technologies

Description

Job Description

Senior Human Factors Engineer

Warwick - Hybrid Working

£50, ,000 + Upto 10% bonus

As a Senior Human Factors Engineer, you will support all aspects of human factors (HF) and usability engineering (UE) of the Quanta Dialysis System (QDS), ensuring compliance with the medical device human factors regulations and standards.

You will support Quanta's Lead Human Factors Engineer on projects and activities that span the whole product life cycle from innovation to existing devices (including both physical and digital user interfaces).

Quanta Dialysis Technologies pioneers innovative haemodialysis systems, revolutionising renal care. QDS offers flexibility, ease, and efficiency in dialysis treatment. Designed for simplicity and convenience, Quanta's breakthrough technology aims to enhance patient experience and improve outcomes in renal therapy.

KEY RESPONSIBILITIES

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.).

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
• 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