Process Development Engineer
Process Development Engineer - Medical Devices (Neuro | Catheters | NPI)
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.
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