Manufacturing Engineer in Penarth

We are looking for a hands‑on and driven Manufacturing Engineer to support and enhance our production operations. This role plays a critical part in resolving daily production challenges, maintaining manufacturing documentation, transferring new processes into production, and driving continuous improvement across the manufacturing line. If you thrive in a fast‑paced environment, enjoy solving real production problems, and want to make a measurable impact on quality and efficiency, this could be a strong fit.

Key Responsibilities

• Provide day‑to‑day engineering support to production to ensure targets for quality, output, yield, and on‑time delivery are consistently met.
• Ensure manufacturing activities comply with QMS, cGMP, and applicable regulatory standards.
• Optimise production efficiency, cost performance, and product quality.
• Perform process, software, and equipment validation including IQ, OQ, and PQ.
• Develop, review, and maintain manufacturing documentation such as work instructions, forms, drawings, BOMs, and risk management files.
• Manage and control label printing processes and artwork accuracy.
• Conduct manufacturing and process training for production personnel.
• Lead root cause investigations for process issues and non‑conformances.
• Implement corrective and preventive actions and verify their effectiveness.
• Drive continuous improvement initiatives using structured problem‑solving methodologies.
• Support new product and process transfers from development into full‑scale production.
• Foster a strong teamwork culture across engineering and production teams.
• Perform other related duties as assigned.

Job Requirements

• Bachelor’s Degree in Mechanical, Industrial, Manufacturing Engineering, or equivalent.
• Minimum 2 years of experience in medical device manufacturing is preferred.
• Knowledge of Risk Management and EN ISO 14971 is an advantage.
• Familiarity with Lean, 5S, and Six Sigma principles.
• Basic understanding of project management, validation strategies, and quality tools.
• Strong ability to manage projects and deliver results within deadlines.
• Good communication, teamwork, and interpersonal skills.

Why Join Us

You will be part of a collaborative environment where engineering expertise directly impacts product quality and operational performance. We value initiative, accountability, and continuous improvement.