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Human factors / usability engineer

Bury St Edmunds
Six Ventures Ltd
Engineer
Posted: 10h ago
Offer description

Are you passionate about designing intuitive, user-friendly medical devices that improve patient outcomes? We're working with a leading innovator in the medical technology space who is looking for a Human Factors Engineer to join their talented and collaborative team.

In this role, you'll take the lead on usability and human factors activities throughout the entire product development lifecycle—from early concept to commercial launch. Your work will directly influence the safety, effectiveness, and usability of ground-breaking medical products, all while navigating global regulatory standards.

Key Responsibilities:

* Generate usability documentation in line with ISO 13485, IEC 62366, and regulatory requirements (MDR, FDA, etc.) for medical product submissions.

* Plan, moderate, and run use studies including formative and summative evaluations.

* Collaborate closely with customers, users, and clinical experts to gather insights and user needs.

* Work hand-in-hand with design, engineering, and project teams to support user-centred product development.

* Conduct use-related risk analysis and contribute to the broader risk management process.

* Participate in internal and client-facing meetings.

* Ensure all human factors activities align with relevant quality systems and regulatory frameworks.

* Occasional travel (UK and international) may be required for project needs.

Full training and support will be provided to help you thrive in this role.

About You:

You’re a detail-oriented and user-focused engineer who enjoys working across disciplines to create products that truly meet user needs. You have strong documentation skills, regulatory knowledge, and a collaborative spirit.

Requirements:

* A minimum of 2 years' experience in human factors/usability engineering.

* Background in medical device development.

* Solid knowledge of relevant regulatory standards and frameworks (UKCA, MDR, FDA).

* Familiarity with usability standards and guidance (IEC 62366, AAMI HE75).

* Demonstrated experience conducting and analysing user studies.

* Understanding of use-related risk management.

* Excellent communication, organisation, and problem-solving skills.

* Proficiency with Microsoft Office and technical documentation.

Ready to take the next step in your career?
Apply now to join a company that’s shaping the future of medical technology through user-driven innovation

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