Clinical Development Engineer

Medical Engineers Recruitment; Leeds; On-site; GBP 40,000 - 45,000; Full time

Job summary

Medical Engineers Recruitment in Leeds partners with a robotics MedTech company conducting human clinical trials. The role sits in the room with clinicians, training them on the device and running the usability programme end to end.

You will support clinical investigations on site, ensure live-clinical feedback informs design changes, and help prepare regulatory submissions. On-site in Leeds, permanent, full-time, with DOE £40,000–£45,000.

Qualifications

• Degree in biomedical or mechanical engineering, or clinical background with hands‑on technical experience.
• 2–4 years of medical device development within an ISO 13485 QMS.
• Knowledge of ISO 14971 and IEC 62366-1, or ability to pick up quickly.
• Comfort working in clinical settings and procedure rooms during live cases.
• Clear writing skills; documents relied on by others.
• Willingness to travel to the EU and US (~10% per year) with valid passport.

Responsibilities

• Train clinicians and support early clinical use of the device
• Run formative and summative usability evaluations, and own the usability file (IEC 62366-1)
• Work directly with clinical sites on study protocols and data collection, in the room during live procedures
• Turn what you hear from clinicians into real requirements and design changes
• Contribute to use-related risk management under ISO 14971
• Coordinate V&V testing across internal teams, external labs and suppliers
• Prepare clinical and usability documentation for regulatory submissions, including FDA 510(k)

Skills

Clinical usability experience

Regulatory knowledge

Technical writing

Education

Bachelor's degree in Biomedical or Mechanical Engineering

Tools

ISO 14971

IEC 62366-1

ISO 13485

Job description

Most engineers work miles away from the people who use what they build. This one works in the room with them.

A Leeds-based robotics MedTech company with a decade of research at the University of Leeds is already in human clinical trials and now they need someone to sit right at the point where clinical reality meets engineering design.

You'll train clinicians on the device, run the usability programme end to end, support clinical investigations on site, and make sure what happens in a clinical setting actually changes the design.

What the role actually involves:

• Training clinicians and supporting early clinical use of the device
• Running formative and summative usability evaluations, and owning the usability engineering file (IEC 62366-1)
• Working directly with clinical sites on study protocols and data collection, in the room during real procedures
• Turning what you hear from clinicians into real requirements and design changes
• Contributing to use-related risk management under ISO 14971
• Coordinating V&V testing across internal teams, external labs and suppliers
• Preparing clinical and usability documentation for regulatory submissions, including FDA 510(k)

What you'll need:

• A degree in biomedical or mechanical engineering, or a clinical background with hands‑on technical experience
• 2 - 4 years of medical device development experience within a quality management system (ISO 13485)
• Working knowledge of ISO 14971 and IEC 62366-1, or the ability to pick them up fast
• Genuine comfort in a clinical setting, you'll be in procedure rooms during live cases
• Careful, clear writing - the documents you produce, other people rely on
• Willingness to travel to the EU and US (~10% of the year, usually in blocks), with a valid passport and the ability to get a US ESTA or visa

Endoscopy, catheter, or surgical robotics experience is a bonus, not a requirement. Having supported a clinical investigation or regulatory submission before is a bonus too.

Leeds, office-based with some flexibility | £40,000–£45,000 DOE | Permanent, full-time

Right to work in the UK required, sponsorship isn't available for this role.