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:
Essential:
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.
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