Senior R&D Engineer
Role Overview: We are seeking a Senior R&D Engineer to join our team on a permanent basis. In this key role, you will provide electrical and electronic engineering expertise to support the design, development, and testing of medical devices, specifically focusing on catheter-based ablative therapies such as Renal Denervation (RDN). You will lead the design and troubleshooting of integrated hardware/software systems for single-use devices (SUDs), ensure regulatory and safety compliance, and contribute to innovation and intellectual property efforts to develop safe and effective therapy delivery systems.
Primary Responsibilities:
* Design, develop, debug, modify, and test electrical circuits and systems for therapeutic ablation catheters and their consoles using modern tools and techniques.
* Lead root cause analysis and troubleshooting of electronic failures at the component and system level, driving corrective solutions.
* Manage development and evaluation of new catheter prototypes and console interfaces from concept through product launch in collaboration with cross-functional teams.
* Analyze, verify, and validate requirements, circuits, and integrated systems, ensuring seamless hardware, firmware, and physiological signal acquisition.
* Research, select, and implement electronic circuits, components, tools, and methodologies suitable for advanced ablative therapy devices.
* Maintain comprehensive documentation of electrical development activities in accordance with quality system standards (protocols, technical reports, change requests, design history files).
* Ensure all designs and products comply with medical device safety and electromagnetic compatibility (EMC) standards such as IEC60601.
* Mentor and guide junior engineers and technicians, fostering their technical growth and contributing to a high-performing team.
* Translate clinical requirements into robust engineering solutions, identifying innovative opportunities and contributing to intellectual property generation.
* Communicate project status, risks, and milestones clearly to project leaders and senior management during regular meetings.
* Uphold a strong commitment to patient safety and product quality by strict adherence to the Quality Policy and all relevant quality procedures.
* Ensure availability of appropriate personnel, tools, and resources to maintain compliance with the Quality Management System and organizational policies.
Qualifications & Experience:
* Level 8 Honours Bachelor's Degree in Electrical Engineering.
* At least 5 years' experience in medical devices or similarly regulated industries, with preference for work on catheter-based or implantable systems.
* Demonstrated skills in circuit and system design, troubleshooting, and root cause analysis.
* Proven knowledge of regulatory and safety standards, including IEC60601 series and EMC requirements.
* Excellent communication, technical documentation, and project management capabilities. Desirable:
* Experience with ablative energy modalities such as RF, ultrasound, IVL, or PFA.
* Familiarity with firmware debugging, digital logic design, FPGA technology, and system integration principles.
* Competence in data analysis tools such as LabVIEW, MATLAB, Python, and automated testing frameworks.
* Experience in intellectual property activities such as patent writing and disclosures.
* Proven leadership and mentoring experience within multidisciplinary teams.