R&D Engineer 2/3
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)
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