Job Description
Senior R&D Engineer – South Wales (site based) – Medical Device
About the Company:
We are seeking a senior R&D Engineer to join an innovative MedTech company in South Wales. The R&D Engineering team leads in innovation, working with technical experts and company leadership to solve complex engineering challenges. You will take full technical ownership of critical subsystems impacting clinical performance, user experience, and device safety. Your work will directly influence product evolution, collaborating across disciplines and with external partners to deliver impactful solutions aligned with our business goals.
Responsibilities:
* Design, develop, and validate the product in compliance with global regulatory standards.
* Collaborate with regulatory affairs, manufacturing, clinical teams, and external partners to ensure product viability and regulatory compliance.
* Lead material selection, prototype fabrication, and performance testing to meet design and clinical requirements.
* Develop and execute verification and validation plans following industry and regulatory guidelines.
* Analyze data to identify performance gaps, troubleshoot issues, and implement design improvements.
* Maintain compliance by staying updated with standards such as ISO 13485 and FDA regulations.
* Support patent development and document new technologies for the company's IP portfolio.
* Mentor team members and promote a culture of innovation and collaboration.
Requirements:
* Bachelor’s degree or higher in Engineering or Science.
* Experience in R&D and product development within the medical device industry.
* Knowledge of medical device design, testing, and validation.
* Experience with experimental design and data analysis.
* Understanding of regulatory standards like FDA and ISO 13485.
* Motivated, dependable, goal-oriented, and adaptable to a fast-paced environment.
* Self-driven with initiative and the ability to work independently.
* Willingness to learn new technical skills continuously.
* Strong problem-solving, collaboration, and communication skills.
* Ability to communicate complex concepts to diverse audiences.
* Experience in start-up environments is a plus.
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