Senior Usability Engineer

Luminate; Galway; Hybrid; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Health insurance

Pension

Flexible working hours

Generous vacation policy

Job summary

Luminate Medical is seeking a Senior Usability Engineer to drive usability activities from concept through validation in cancer care products. You will translate patient and clinician needs into safe, intuitive designs and work with cross-functional teams to mitigate use-related risks.

This role focuses on planning studies, developing usability plans, and ensuring regulatory alignment within a fast-growing R&D environment at a company dedicated to patient impact.

Qualifications

• Minimum 3 years of relevant experience in usability engineering, preferably with medical devices or regulated healthcare products.
• Experience planning, conducting, analysing and documenting usability studies.
• Strong written and verbal communication across R&D, clinical and RA/QA teams.
• Knowledge of IEC 62366-1 and ISO 14971 risk management and how usability activities connect with regulatory submissions.
• Ability to translate patient and clinician needs into design inputs and requirements.

Responsibilities

• Plan and coordinate usability engineering activities with R&D Lead, Project Manager, RA/QA.
• Define user groups, environments and interactions across the product lifecycle.
• Develop and maintain usability plans and documentation.
• Conduct formative and summative usability studies and prepare study reports.

Skills

Human Factors

Usability Engineering

Regulatory knowledge

IEC 62366-1

User research

Education

Human Factors / Usability Engineering (Bachelor's or higher)

Job description

Shape the Future of Cancer Treatment at Luminate Medical

At Luminate, our mission is to make cancer care more human. We design and build technologies that help oncologists make cancer care better, faster, and safer for patients.

We're looking for a Senior Usability Engineer to become the next key player in our R&D team. You will be a key contributor to our fast-moving and growing product development team, ensuring patient and healthcare professional needs are translated into products that are safe, intuitive, and easy to use. You will drive usability engineering activities from early concept development through to usability validation. Working with cross functional teams, you will investigate user needs, identify use-related risks, plan and conduct usability studies, and translate findings into actionable design improvements.

This position requires a collaborative, proactive person who can take ownership of usability activities while contributing to broader product development. Above all, you will need a passion for understanding patients’ experiences and finding creative solutions that translate innovative technology into real patient impact.

Working at Luminate Medical

• This is a key hire at a rapidly growing company. You will have an opportunity to shape the development of multiple high-impact patient-facing products and gain first-hand insights into the growth of a start-up.
• We offer a highly competitive salary comparable with multinational medical device companies and a flexible benefits package including health insurance and pension.
• We believe in quality of life in our products and for our people, and offer flexible working hours, and a generous vacation policy.

What You Will Do:

• Plan and coordinate usability engineering activities in collaboration with the R&D Lead, Project Manager, and RA/QA team.
• Define intended user groups, use environments, and user interactions throughout the product lifecycle.
• Develop and maintain usability engineering plans and supporting documentation.
• Integrate usability activities into product development milestones, ensuring that user insights inform decisions early and throughout development

Understand patient and healthcare professional needs

• Plan and conduct user interviews, observations, workflow assessments, and other research activities with patients, healthcare professionals, and caregivers, as appropriate.
• Translate research findings into clear user needs, design inputs, and user-interface requirements.
• Communicate findings through concise reports, task analyses, user journeys, and actionable recommendations.

Identify and reduce use-related risks

• Conduct task analyses and contribute to use-related risk assessments with R&D and RA/QA.
• Identify potential use errors, hazardous use scenarios, and critical tasks.
• Work with the development team to implement and evaluate design measures that reduce use-related risk.
• Assess usability across the complete user interface, including device controls, displays, accessories, packaging, labelling, instructions for use, and training materials, where applicable.

Plan and deliver usability studies

• Design and conduct formative usability studies to evaluate concepts and prototypes throughout development.
• Prepare study protocols, participant criteria, task scenarios, moderator guides, and data collection materials.
• Coordinate participant recruitment, study logistics, external research partners, and suitable testing environments.
• Observe and document user interactions, use errors, difficulties, and feedback.
• Analyse findings and work with the product development team to prioritise and implement design improvements.
• Plan and execute summative usability validation activities.
• Prepare clear study reports, including findings, root-cause analysis and recommendations.

Contribute to product design and regulatory documentation

• Participate in design reviews, product brainstorms and prototype evaluations.
• Help the team evaluate trade-offs between usability, technical performance, manufacturability and patient needs.
• Develop and maintain the Usability Engineering File and contribute relevant documentation to the Design History File and regulatory submissions.
• Work within the company’s Quality Management System to ensure usability activities are appropriately planned, documented and reviewed.
• Help establish practical usability templates, methods and processes that can grow with the company.

Take responsibility for delivering project goals

• Take ownership of assigned usability activities, timelines and deliverables.
• Work closely with the R&D Lead, Project Manager and RA/QA team to maintain agreed schedules and quality standards.
• Build effective relationships with clinical collaborators, study participants, external usability consultants and research partners.
• Communicate progress, findings, risks and resource requirements clearly.
• Share usability knowledge with colleagues and champion evidence-based, patient-focused design decisions.

Personal Attributes – The Ideal Candidate Is:

• Open: A proactive team player who helps colleagues develop, contributes positively to company culture, and gives and receives constructive feedback.
• Communicative: Able to articulate ideas clearly, support recommendations with evidence, and communicate effectively with patients, healthcare professionals and technical colleagues.
• Empathetic: Curious about people’s experiences and sensitive to the challenges faced by patients undergoing cancer treatment.
• Self-driven: Resourceful and independent, with a sense of urgency and a willingness to take responsibility for tasks.
• Organised: Able to prioritise research and documentation activities, coordinate study logistics and deliver actions on time.
• Analytical: Comfortable interpreting qualitative and quantitative findings, investigating the causes of user difficulties and translating evidence into practical improvements.
• Creative: Enthusiastic about new ideas and willing to explore different approaches to solving usability challenges.

Experience Requirements – The Ideal Candidate Must Have:

• A relevant qualification in Human Factors, Usability Engineering, Biomedical Engineering, Psychology, Ergonomics, Product Design, Human-Computer Interaction, or a related discipline or equivalent practical experience.
• At least 3 years of relevant experience in usability engineering, human factors, or user-centred product development, including experience with medical devices or another regulated healthcare product.
• Practical experience planning, conducting, analysing and documenting usability studies.
• An understanding of medical device usability engineering, including IEC 62366-1, and how usability activities connect with ISO 14971 risk management.
• Experience writing formal research or testing protocols/reports and contributing to controlled product development documentation.
• Strong written and verbal communication skills and the ability to collaborate across R&D, clinical and RA/QA teams.

Experience Advantages – It Would Be Advantageous to Have:

• Experience planning or executing summative usability validation studies for medical devices.
• Familiarity with FDA human factors guidance and human factors documentation supporting US or European market submissions.
• Experience working with wearable devices, patient-facing products or products used in oncology.
• Experience conducting research with patients, caregivers or healthcare professionals.
• Experience evaluating physical interfaces, device fit and comfort, donning and doffing, cleaning, maintenance and treatment workflows.
• Experience developing or evaluating instructions for use, packaging, labelling and training materials.

Don't have all of these requirements?

Some people are less likely to apply for a role unless they are 100% qualified. Your experience, skills and passion will set you apart – tell us what you have learned and achieved, whether personal or work-related! With the right mindset, many of the skills above can be learned on the job. If this role excites you, don't let the description hold you back!