Senior R&D Engineer – South Wales (site based) – Medical Device

About the Company:

We are looking for a senior R&D Engineer to join an innovative MedTech company in South Wales. The R&D Engineering team are at the forefront of innovation, collaborating with technical experts and company leadership to solve complex engineering challenges. In this role, you will take full technical ownership of critical subsystems that influence clinical performance, user experience, and overall device safety. Your contributions will directly shape the evolution of the product, working across disciplines and with external partners to deliver impactful solutions aligned with our business goals.

Responsibilities:

Drive the end-to-end design, development, and experimental validation of the product in compliance with global regulatory standards. Partner with cross-functional stakeholders—including regulatory affairs, manufacturing, clinical teams, and external collaborators—to ensure product viability and regulatory readiness. Lead material selection processes, prototype fabrication, and performance testing to meet design and clinical requirements. Create and execute robust verification and validation plans in line with industry benchmarks and regulatory guidelines. Interpret complex data sets to identify performance gaps, troubleshoot technical issues, and implement iterative design improvements. Ensure continuous compliance by staying current with evolving standards such as ISO 13485 and FDA regulations. Contribute to the company’s intellectual property portfolio by supporting patent development and documentation of novel technologies. Provide technical mentorship and foster a culture of innovation and collaboration within the R&D team.

Requirements:

Bachelor’s degree or higher in Engineering or Science. Experience in R&D and product development within the regenerative medical device industry. Expertise in medical device design, testing, and validation and verification processes. Strong understanding of experimental design and data analysis to support statistically sound conclusions. Familiarity with regulatory standards and approval pathways for medical devices (e.g., FDA, ISO 13485). Highly motivated, dependable, and goal-oriented, with the ability to adapt and thrive in a fast-paced, small-team environment. Self-driven with a strong capacity for independent work and initiative. Willingness to continuously learn and develop new technical skills. Exceptional problem-solving abilities paired with excellent collaboration and communication skills. Able to effectively communicate complex technical concepts to both technical and non-technical audiences. Experience working for start-ups is .