Human Factors Consultant

Posted Yesterday
Be an Early Applicant
Bristol, England, GBR
Hybrid
41K-53K Annually
Mid level
Healthtech • Pharmaceutical • Design • Manufacturing
The Role
Plan, run and report formative and summative usability studies for medical and consumer health products. Contribute regulatory documentation for global submissions, manage participant recruitment and study moderation, perform use‑error and root‑cause analysis, support risk management and protocol drafting, work within a QMS, and assist business development and client communication.
Summary Generated by Built In

About the role

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.

About you

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.

Your skills and experience

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.

Why work with us?

Ensera Design offers interesting and varied work combined with a supportive team culture to provide a stimulating environment where you will have the opportunity to develop and learn from others. We offer flexible working policies where working patterns are agreed with our line managers, taking into account the role, needs of the individual, and the team.

We recognise that we are only as good as our people and we know how important it is to support our team.

We offer:

  • Performance-related company-wide bonus.

  • Flexible hybrid working in line with our core hours (Mon–Thu, 9:30am–12:00pm & 2:00pm–4:00pm; Fri, 9:30am–12:00pm).

  • Private healthcare for you and your family.

  • Enhanced maternity and paternity leave.

  • Salary exchange pension scheme.

  • 25 days of annual leave, plus the option to purchase up to one working week and additional days for length of service.

  • Access to our Employee Assistance Programme and digital wellbeing platform.

  • Cycle to Work & Electric Vehicle Lease schemes.

  • Death in service (x4 gross salary).

  • Training and development opportunities, including dedicated learning days and regular knowledge-sharing sessions.

  • A free lunch the first Monday of every month alongside our company-wide meeting.

  • Free breakfast every Wednesday, and plenty of opportunities to socialise, including team-organized activities, summer and Christmas parties, and more.

About us

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:

  • Find a way: We work as one team, combining our knowledge and experience to unite around a shared goal. We trust each other and do what’s needed to get things done and exceed expectations.

  • Pull together: We believe anything is possible. When faced with challenges we take the initiative, using our creative spirit and determination to find bold solutions and deliver results that move us forward.

  • Care: We act with integrity, take pride in our work, and support each other. We each play our part to make a positive impact for our customers, our colleagues, and our planet.

Our diverse, multidisciplinary team spans research, design, human factors, engineering, prototyping, manufacturing, and beyond. Together, we deliver cutting-edge solutions for clients ranging from global leaders to innovative start-ups, with a particular focus on medical devices, drug delivery, orthopaedics, and diagnostics.

Do we sound like a good match for you?

If you’d like to discuss the role or would like to discuss any reasonable adjustments you may need to make your application, we’d love to hear from you. If you think you might be the right person for us but want an informal chat first then get in touch via [email protected].

Please note we intend to review applications as they come in and we reserve the right to close the vacancy if we have a high level of applications. We look forward to hearing from you!

At Ensera Design we believe that designing for people means including all people, starting with the team behind the work. Our human-centred design ethos is rooted in empathy, and our values – pull together, find a way, and care – guide us in building a team that reflects the diversity of the world we design for.

We know that different perspectives lead to better ideas, stronger collaboration, and more meaningful outcomes. If you meet the skills and experience for this role, we welcome your application – whatever your background, identity, or path into design. What matters to us is that you share our belief in purposeful, people-first design.

Polite notice for agencies – We appreciate the interest from recruitment partners; however, we are managing this hiring process directly and ask that agencies do not contact us regarding this role. Unsolicited CVs will be considered as a gift to Ensera Design.

Skills Required

  • Demonstrable experience in Human Factors roles including medical devices, digital user interfaces, packaging, labelling and instructions for use.
  • Understanding of IEC 62366-1, ISO 14971 and FDA Guidelines.
  • Experience conducting formative and summative/validation studies.
  • Experience in risk management, study planning, protocol drafting, participant recruitment management, study moderation, use error and root cause analysis, and reporting/presenting recommendations.
  • Experience of working within a Quality Management System (QMS).
  • High standard of written and verbal communication skills, including presenting to others.
  • High level of commercial awareness and excellent project management skills.
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The Company
123 Employees
Year Founded: 1977

What We Do

Ensera Design is a global healthcare innovation partner and design and product development consultancy specializing in human-centered MedTech, pharmaceutical, and consumer health product design and development. Formed by uniting studios HS Design and Kinneir Dufort, the company provides end-to-end support from initial concept through to commercial manufacturing, delivering safe, effective, and market-ready solutions designed to improve global health outcomes.

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