Colin Cotton

Senior Manufacturing Engineer

Sep 2025 - Present • 8 mos

I am an experienced manufacturing and process engineer specialising in medical device development, validation, and troubleshooting within regulated environments. I have supported medical device companies through development, validation, and production. My work includes IQ/OQ/PQ execution, PFMEA development, and setting up validated bonding, sealing, and mechanical test methods. Achievements include releasing validated packaging and bonding processes, supporting audit readiness, and resolving production issues in cleanroom operations, with a strong focus on ISO 13485 compliance documentation...

Manufacturing engineer

Apr 2022 - Aug 2025 • 3 yrs 4 mos

I worked as a manufacturing engineer supporting high‑volume balloon manufacturing operations, with responsibility for process development, optimisation, and day‑to‑day production support. The role focused on ensuring consistent product quality, stable processes, and efficient manufacturing output. I supported the setup and validation of manufacturing equipment and production processes, including documenting process parameters, defining control limits, and implementing process improvements to reduce defects and waste. I worked closely with production teams to troubleshoot manufacturing issues, identify root causes, and implement corrective actions to improve yield and reliability. Key achievements included improving process consistency, reducing scrap rates, supporting equipment optimisation, and contributing to standardised work instructions and process documentation. The role required a hands‑on approach on the production floor, strong attention to detail, and close collaboration with operations, quality, and maintenance teams.