Process Development Engineer

Overview

We are seeking a highly capable Process Development Engineer to join our Neuro division, supporting the development and industrialisation of catheter-based medical devices. This role focuses on New Product Introduction (NPI), process innovation, and ensuring scalable, reliable manufacturing processes for complex neurovascular technologies.

Key Responsibilities

Process Development & NPI

• Lead end‑to‑end process development activities for catheter-based medical devices from concept through launch.
• Develop, optimise, and validate robust manufacturing processes (IQ/OQ/PQ) in accordance with FDA, ISO 13485, and internal quality systems.
• Partner closely with R&D, Quality, and Operations to ensure seamless transfer of new products into production.

Catheter Manufacturing Expertise

• Develop deep understanding of catheter processes: extrusion, braiding/coiling, thermal bonding, laser processing, assembly, and functional testing.
• Implement process controls and capability improvements to ensure consistency and compliance.
• Troubleshoot process issues and drive root cause analysis using structured problem‑solving tools (DMAIC, 8D, PFMEA).

Documentation & Compliance

• Generate and maintain high‑quality documentation: process specifications, risk management files, validation protocols/reports, and work instructions.
• Ensure full compliance with regulatory expectations for neurovascular medical devices.

Continuous Improvement

• Identify opportunities to improve yield, throughput, and cost through Lean and Six Sigma methodologies.
• Introduce new equipment, automation, or tooling solutions to enhance process robustness.