Job Title: Clinical Test Engineer
Location: Leeds (Full-time, On-site)
Salary range: 35,000 – 40,000 GBP / Year
The company
Atlas Endoscopy aims to revolutionize colonoscopy with its advanced robotic system, enhancing healthcare capacity. Founded by experts in business, clinical, regulatory, and technology fields, Atlas collaborates with diverse endoscopists and healthcare providers to create a comprehensive solution for diagnostic and interventional colonoscopy.
The Team
Atlas Endoscopy is a rapidly growing startup, characterised by a dynamic environment and a young, diverse, and motivated team of engineers. Our vibrant R&D team consists of 10 dedicated professionals, including clinical, software, hardware, and electronics engineers. This collective ingenuity drives our innovative approach to revolutionizing colonoscopy.
This role is an exciting opportunity to join a small and innovative R&D team. Joining Atlas Endoscopy means becoming part of a team devoted to leveraging technology to enhance patient care by improving endoscopy efficacy and reducing invasiveness, with patient outcomes as our highest priority.
Job Description
Reporting directly to the Quality Assurance and Regulatory Affairs Director, the Test Engineer will play a crucial role in designing and executing testing for product Verification and Validation (V&V) according to industry best practices and the most up-to-date regulatory standards. They will have the technical expertise to handle complex testing challenges and propose innovative solutions to enhance our cutting-edge medical technology. The ideal candidate will excel in designing and prototyping test rigs using electronics, mechanics, and CAD software components. If you are passionate about improving patient outcomes through technology, this position offers an exciting opportunity to contribute to groundbreaking advancements in healthcare.
Key Responsibilities
* Develop test protocols and write comprehensive test reports.
* Execute tests and analyse results.
* Conduct literature reviews to support testing activities.
* Design and develop test rigs using SolidWorks or similar CAD software.
* Utilize 3D printing technology for test rig development.
* Work efficiently in a small team environment.
Qualifications
* Experience working in a quality-controlled environment aligned with ISO 13485:2016.
* Familiarity with relevant ISO standards:
* ISO 13485:2016 and/or FDA 21 CFR Part 820 and related guidance (desirable)
* ISO 14971 (desirable)
* IEC 60601-1/2 (beneficial)
* IEC 62304 (beneficial)
* ISO 10993 (beneficial)
* ISO 62366 (beneficial)
* Awareness of the design control process for medical devices, particularly verification and validation.
* Strong problem-solving skills and attention to detail.
* Excellent communication and teamwork abilities.
Preferred Skills
* Strong technical writing skills for test report creation.
* Experience with SolidWorks or similar CAD software.
* Knowledge of 3D printing technology.
* If you are passionate about contributing to the development of innovative medical devices and meet the qualifications listed above, we encourage you to apply.