Job Description
As a Senior R&D Engineer, you'll lead the design and development of cutting-edge electromechanical interventional devices. You'll take projects from concept through to commercialisation in a dynamic, start-up-style environment.
Provide technical leadership and support the development of pioneering catheter-based technologies. Play a key role in shaping next-generation medical solutions as a collaborative, forward-thinking team member.
Key Responsibilities:
* Lead the end-to-end design and development of electromechanical interventional devices, ensuring compliance with ISO 13485 and FDA 21 CFR Part 820 Design Control requirements.
* Engage with physicians and key stakeholders to gather clinically relevant feedback and optimise product designs.
* Manage and maintain the Design History File (DHF), risk management files, and design verification/validation documentation.
* Apply advanced engineering tools such as DOE, SPC, and Minitab to support robust product development.
* Lead and participate in Design Reviews, ensuring comprehensive technical documentation.
* Mentor and provide technical guidance to junior team members, fostering team development.
* Identify and implement new technologies to optimise device design, material selection, and manufacturing processes.
* Support intellectual property (IP) generation activities arising from R&D efforts.
Required Skills & Qualifications
Requirements:
* Level 8 degree in Engineering, Science, or a related discipline.
* 5 years of experience in medical device R&D, specifically in catheter development and electromechanical device design.
* Proven track record of leading design teams and coordinating cross-functional projects.
* Strong working knowledge of catheter technology, biocompatible materials (metal and polymer), and related testing/manufacturing processes.
* Availability for limited travel to support clinical trials and project milestones.
Benefits
For more details on this role, feel free to reach out to Emma Cawley at [No contact information provided].
Given the expected high volume of applications, we can only respond to candidates whose qualifications closely match the specific requirements of the role.
We genuinely value your interest in this opportunity and thank you for your understanding.