Our client ACT Medical is dedicated to developing innovative medical devices that revolutionise the treatment of catastrophic haemorrhage. We are seeking a highly skilled and motivated Usability Engineer to join our dynamic team. The initial contact is for a fixed term of 6 months, which may extend subject to funding. 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.
Joining us at this exciting time in our product development, you will take the lead and manage focused usability engineering activities across a defined 6 month programme of work within our medical device development lifecycle. The primary focus of this contract is to plan, execute, and report a formative usability study with pre‑hospital and hospital users, and to prepare for a subsequent summative usability study. The role also includes creating and maintaining usability documentation to ensure compliance with IEC 62366‑1, ISO 14971, and FDA regulations, and supporting grant reporting related to usability activities.
The expected phase focus is:
* Months 1–2: Planning the formative usability study
* Months 3–4: Executing the formative study, analysing results, and generating usability recommendations
* Months 5–6: Supporting grant reporting and planning the summative usability study
Responsibilities
* Develop and implement the usability engineering strategy for the defined contract scope.
* Conduct user research, task analysis and create use scenarios.
* Plan the formative usability study (Months 1–2), including protocols, task definitions, risk‑based critical task identification, and study materials.
* Execute formative usability studies (Months 3–4) to gather user feedback and identify design improvements.
* Analyse usability study data and generate actionable insights and prioritised design recommendations.
* Support grant reporting activities related to usability engineering outputs and study results (Months 5–6).
* Develop the summative usability study plan and supporting documentation (Months 5–6), aligned with FDA expectations.
* 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.
* 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.
Skills and Qualifications
* Bachelor’s or Master’s degree in Human Factors Engineering, Industrial Design, Product/ Interaction Design, Psychology, or a related field.
* Proven 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.
Further information regarding ACT Medical can be found at https://www.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. No agencies please.
Job Type: Full-time, Initial Fixed Term of 6 months
Pay: £45,000.00-£55,000.00 per year
* Additional leave
* Company pension
* Sick pay
Work Location: In person at Cambridge CB1 3NA
#J-18808-Ljbffr