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Usability Engineering Specialist (Contract)
About Wellumio

Wellumio is a venture-backed medical device company on a mission to create universal access to diagnostic imaging.

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Magnetic resonance is the gold standard modality in medical imaging due to its exceptional soft tissue contrast. However, its accessibility is limited by high costs and the need to transport patients to scanners. At Wellumio, we are driven by a simple yet transformative idea: instead of bringing patients to the scanner, we bring the scanner to the patients, wherever it is needed.

 

By providing point-of-care imaging, Wellumio enables healthcare professionals to deliver earlier diagnoses, faster treatments, and better outcomes. Our second-generation scanner, Axana, is 99% lighter than conventional MRI systems, making it the most portable head magnetic resonance imaging system in the global brain and neuroimaging market.

 

The company's first target application is acute stroke, a leading cause of human mortality and disability. Currently, only 1.5% of patients receive treatment within the critical time window due to reliance on in-hospital imaging. Wellumio's point-of-care solution addresses this, making effective stroke treatment accessible wherever patients are.

 

With stroke projected to cause 7.5 million deaths and cost $1 trillion annually by 2030, there is an urgent need for cost-effective technologies that can streamline care pathways for stroke and other neurological conditions where time is critical.

 

Why should you be part of Wellumio's success story?

  • To work with a talented and passionate team dedicated to positively impacting the medical device industry.

  • To grow your skills and knowledge through ongoing training and development opportunities.

  • To work in a dynamic environment that rewards creativity, innovation, hard work, and continuous improvement.

 

At Wellumio we're challenging dominant models of clinical service delivery by fusing technology, design innovation, medical expertise, and systems-level thinking to create imaging solutions that put the needs of patients first.

About the Role

The Usability Engineering Specialist provides ongoing human factors and usability engineering expertise to Wellumio, supporting the design and validation of Axana's user interface and clinical workflow. This is an ongoing contract engagement through May 2027, focused on ensuring Axana meets IEC 62366-1 requirements and that its usability in clinical environments is systematically studied, documented, and improved. This is the primary point of accountability for usability engineering at Wellumio, working across R&D, clinical, and quality functions.

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Soft Skills Requirements

  • Strong problem-solving and analytical skills

  • Ability to work independently and as part of a team

  • Good communication and collaboration skills

  • Willingness to learn and continuously develop technical expertise

  • Professionalism, reliability, and attention to detail

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  •  Degree in Human Factors Engineering, Cognitive Psychology, Industrial Design, or equivalent

  • 5+ years of usability engineering experience applied to medical devices or safety-critical systems

  • Demonstrated track record executing IEC 62366-1 compliant usability engineering programmes

  • Experience conducting clinical environment observation or contextual inquiry preferred

 

Technical Capabilities

  • IEC 62366-1 application: summative and formative study design, execution, and reporting

  • Human factors methods: task analysis, heuristic evaluation, think-aloud protocols, and usability testing

  • Risk integration: connecting use-related risks to ISO 14971 risk management activities

  • FDA Human Factors Guidance and IEC 62366 regulatory interpretation

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Skills & Behaviours

  • Champions the end user — the clinical professional and their patient — in every design discussion

  • Translates user research into engineering-actionable requirements, not just observational notes

  • Produces regulatory-grade documentation without making it inaccessible or over-engineered

  • Reliable and professional in a remote, async-first engagement environment

Key Responsibilities

Working in partnership with relevant departments, you will:

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Usability Engineering Process (IEC 62366-1)

  • Develop and maintain the usability engineering file in full accordance with IEC 62366-1

  • Define the use specification: intended users, intended use environments, and intended user interactions for Axana

  • Identify, analyse, and evaluate use-related risks that could result in harm to patients or clinical users

 

Formative & Summative Evaluation

  • Plan, conduct, and document formative usability studies throughout the device development cycle

  • Design the summative (validation) usability evaluation: test scenarios, tasks, participant criteria, and acceptance criteria

  • Produce usability evaluation reports suitable for inclusion in the technical file and regulatory submissions

 

User Interface Design Input

  • Provide evidence-based recommendations to hardware, software, and clinical teams on user interface design

  • Translate user research findings into specific design requirements and usability test criteria

  • Participate in design reviews to evaluate the usability implications of proposed design changes


Clinical Workflow Analysis

  • Conduct contextual inquiry and task analysis in clinical environments relevant to Axana's use contexts (ED, ICU, ambulance)

  • Define and document the clinical workflows Axana must support without introducing new use errors

  • Work with the clinical team to validate that the device integrates into established care pathways effectively

 

Risk & Regulatory Support

  • Contribute use-related risk analysis to the ISO 14971 risk management file

  • Advise on usability evidence required for TGA, FDA, and CE regulatory submissions

  • Maintain awareness of FDA Human Factors Guidance and IEC 62366 regulatory interpretation developments

Qualifications & Experience
What Success Looks Like

  • Usability engineering file is complete, current, and demonstrably aligned with IEC 62366-1 requirements

  • Summative evaluation is fully designed, ready to execute when the device reaches required maturity

  • Use-related risks are documented in the risk management file and mitigations are validated

  • Regulatory submission usability evidence package is complete and submission-ready for all target markets

  • Design team consistently consults usability engineering before finalising interface decisions

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