Human Factors Consultant

Ensera Design is a world-class user-centred innovation and product development consultancy, specializing in the medical and consumer health sectors with offices in Bristol, Colorado and New Jersey. As part of Ensera, we collaborate globally with contract manufacturing facilities in Europe, the USA, and Asia.

We are currently seeking a Human Factors Consultant to support the delivery of high-quality Human Factors studies and contribute to regulatory documentation for global submissions.

You’ll play a key role in planning, running and reporting usability studies, working closely with senior team members to ensure all outputs meet our quality and regulatory requirements. Alongside project delivery you’ll also support business development by identifying follow-on opportunities, contributing to proposals and communicate with clients as needed.

You may be working in Human Factors already, looking to change to a consultancy environment. You’ll be keen to keep developing your expertise in Human Factors within regulated sectors.

Regardless of your experience level, you’ll be looking to work collaboratively across our internal teams and with our clients.

You’ll enjoy structuring documentation and adhering to regulated standards whilst applying your research skills.

Whilst you do not need to meet all of these points, please ensure you meet the majority of them before making an application:

• Demonstrable experience in Human Factors roles, ideally including medical devices, digital user interfaces, packaging, labelling and instructions for use.

• An understanding of IEC 62366-1, ISO 14971 and FDA Guidelines.

• Some experience of conducting formative and summative/ validation studies.

• Demonstrable experience of risk management, planning studies, protocol drafting, participant recruitment management, study moderation, use error and root cause analysis, and reporting/presenting recommendations.

• Experience of working within a QMS.

• A high standard of communication skills, written and verbal, including presenting to others.

• A high level of commercial awareness and excellent project management skills.

The salary for this role is in line with our Consultant band, £40,800 to £53,000. Please note that we ask you to provide your expected salary within the band as part of your application, this helps us understand how you view your experience against the role’s scope.

We are based in an iconic Grade II listed building in the heart of Bristol. Our vibrant workspace houses state-of-the-art labs, a design studio, usability suites, and collaborative meeting spaces. Nestled in a lively neighbourhood with independent shops, we’re just a short walk from Park Street, the Harbourside, and St. Nick’s Markets.

We are proud of our values: