ACT Medical is dedicated to developing innovative medical devices that revolutionise the treatment of catastrophic haemorrhage. We are currently seeking a highly skilled and motivated Usability Engineer to join our dynamic team. This role will play a critical part in ensuring our devices are safe, effective and intuitive to use in both pre-hospital and hospital environments.

You will lead and manage usability engineering activities throughout the medical device development lifecycle. This includes planning, executing, and documenting formative and summative usability studies with pre-hospital and hospital users. The role also involves creating and maintaining usability documentation to ensure compliance with ISO 62366, ISO 14971, and FDA regulations.

Key Responsibilities:

• Develop and implement the usability engineering strategy for medical device development projects.

• Conduct user research, task analysis and create use scenarios.

• Understand medical device training to

• Plan, design, and execute formative usability studies to gather user feedback and identify design improvements.

• Conduct summative usability studies to demonstrate the safe and effective use of devices, supporting FDA approval requirements.

• Analyse usability study data and generate actionable insights to inform design decisions.

• Support the design and evaluation of packaging to ensure ease of use and compliance with regulatory requirements.

• Assess and incorporate future training requirements for the device into usability studies to validate real-world use.

• Create and maintain usability engineering documentation, including:

  • Usability Engineering Plan

  • Formative and Summative Study Reports

  • Usability FMEA

  • Usability Requirements Traceability

• Ensure usability engineering processes comply with IEC62366, ISO 14971, and FDA regulatory requirements.

• Collaborate closely with cross-functional teams, including design, engineering, regulatory, and clinical teams.

• Present usability findings and recommendations to stakeholders.

• Analyse post-market data and identify usability issues.

Qualifications:

• Bachelor’s or Master’s degree in Human Factors Engineering, Industrial Design, Product/ Interaction Design, Psychology, or a related field.

• 3+ years of experience in usability engineering for medical devices/healthcare products spanning early phases of gathering user needs to late phases of product validation.

• Strong knowledge of IEC62366-1, and FDA usability guidelines.

• Good understanding of quality systems (QMS) and risk management principles.

• Proven experience in planning and conducting formative and summative usability studies.

• Experience working with healthcare professionals in pre-hospital and hospital settings.

• Ability to analyse complex data and generate clear, actionable insights.

• Excellent documentation skills and attention to detail.

• Strong project management and organizational skills.

• Effective communication and presentation skills.

Why Join Us?

• Opportunity to work on innovative, life-saving medical device solutions.

• Collaborative and supportive work environment.

• Professional development opportunities.

• Competitive salary and benefits package.

How to Apply: Please submit your resume and a cover letter detailing your experience and suitability for the role to careers@actmedical.co.uk.

ACT Medical is an equal opportunity employer . We celebrate diversity and are committed to creating an inclusive environment for all employees.

Please note that visa sponsorship is not available for this position.

Please note that this role is contingent upon the availability of funding.