Clinical Development Engineer - In-Room MedTech & Trials

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

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.