Senior R&D Engineer

Key Responsibilities

Product Development & Technical Execution

• Support design refinement and development activities for the Radial L1 delivery system with emphasis on design freeze and design verification activity.
• Execute engineering activities related to catheter design, component selection, materials evaluation and design changes.
• Develop, execute, and document engineering studies to characterise product performance.
• Design, develop, and validate test methods to support product verification activities.
• Author protocols, reports, engineering assessments, specifications and technical documentation.
• Analyse test data and provide clear technical conclusions and recommendations.
• Support risk management activities, design reviews, and technical assessments.

Catheter Engineering

• Contribute technical expertise in catheter design, materials, and manufacturing processes.
• Support development and optimisation of bonded catheter assemblies including adhesive selection, bond development, and bond characterisation.
• Lead troubleshooting and root cause investigations related to catheter performance, materials, manufacturing processes, and product reliability.
• Develop and execute mechanical testing including tensile, bond strength, flexibility, torque, trackability, durability, and related catheter characterisation methods.
• Collaborate with suppliers and manufacturing teams to resolve technical challenges and improve process robustness.

Verification & Problem Solving

• Plan and execute verification testing activities in accordance with project timelines.
• Participate in test method validation and equipment qualification activities.
• Apply structured engineering problem-solving techniques and statistical methods to investigate issues and drive robust solutions.
• Support design change assessments and associated verification activities.
• Drive issues to closure through data-driven decision making.

Cross-Functional Collaboration

• Work effectively within cross-functional project teams including R&D, PD, DA, Manufacturing, Regulatory Affairs, Clinical Affairs, and Supply Chain.
• Present technical work and recommendations to project teams and leadership.
• Support / Mentor junior engineers and technicians where appropriate.
• Demonstrate ownership of deliverables and the ability to work independently with minimal supervision. ( A doer)

The successful candidate will apply strong catheter engineering fundamentals to support design freeze activities, test method development, design verification execution, technical investigations, and documentation required within a regulated medical device development environment.

This role requires an engineer who is comfortable independently driving technical workstreams, taking ownership, while collaborating effectively across R&D, Quality, Regulatory, Manufacturing, and Supply Chain functions.

Focused on design iteration, design freeze execution, DV readiness, test method development, and catheter technical problem-solving ( so executioner not designer focus)