Senior R&D Engineer

Overview

We are seeking an experienced R&D professional to lead the scoping, development, and commercialisation of next-generation Drug-Coated Balloon (DCB) and Catheter technologies. This individual will play a key role in defining product strategy, establishing technical requirements, managing development activities, and driving programs from concept through commercialisation.

Depending on experience, the successful candidate may operate at Senior Engineer, Manager, or Director level, providing both technical leadership and strategic direction across product development, regulatory, manufacturing, and clinical functions.

Key Responsibilities

Product Development & Innovation

• Lead the design and development of Drug-Coated Balloon and Catheter-based technologies from concept through commercialisation.
• Define project scope, technical strategy, product requirements, and development roadmaps.
• Drive feasibility studies, proof-of-concept evaluations, and prototype development.
• Develop innovative catheter, balloon, delivery system, and coating platform technologies.
• Translate clinical and customer requirements into design specifications and product architectures.
• Lead Design Control activities in accordance with FDA and ISO standards.

Technical Leadership

• Act as the technical lead and subject matter expert for catheter and drug-delivery technologies.
• Guide multidisciplinary engineering teams across Mechanical, Biomedical, Materials, Process, Manufacturing and Quality Engineering.
• Oversee design reviews and technical risk assessments.
• Drive problem solving, root cause investigations, and resolution of complex technical challenges.
• Mentor and develop junior engineers and technical teams.

Drug-Coating & Balloon Technology

• Lead development of drug-coated balloon technologies including coating formulation, process development, transfer, and optimisation.
• Define performance requirements relating to:
  • Drug transfer efficiency
  • Coating durability
  • Particulation
  • Balloon performance
  • Deployment characteristics
  • Shelf-life and stability
• Collaborate with coating development specialists, external partners, and contract manufacturers.