Industrialisation Engineer (m/f/d)

About the role

The Industrialisation Engineer will support inspection and repair activities for Olympus‑manufactured medical devices, ensuring product performance, reliability, and patient safety. You will act as a bridge between engineering, quality, and repair operations to implement validated processes across EMEA sites.

Key responsibilities

• Support inspection and repair of endoscopes and peripheral electronic equipment.
• Ensure inspection and repair processes comply with global standards and regulatory requirements.
• Coordinate with Regional Engineering, Quality, Local Repair Operations, and Manufacturing Engineering to sustain validated processes.
• Execute equipment qualification, process validation, and test method validation in line with ISO and FDA standards.
• Contribute to product safety, performance, and compliance throughout the product lifecycle.
• Collaborate cross‑functionally to introduce new products, changes, and updates without service interruption.
• Identify gaps in validation processes, drive standardisation, and enable scalability across sites.
• Safeguard local compliance and quality while supporting operational excellence and customer satisfaction.

Required profile

• Bachelor’s or Master’s degree in Electrical, Mechanical, Biomedical Engineering or a comparable technical field.
• Proven experience in process validation and/or test method validation within a regulated industry.
• Experience in industrialisation projects, preferably in the medical device sector.
• Solid knowledge of quality management systems and regulatory standards such as ISO 13485 and FDA 21 CFR Part 820.
• Fluent in English (written and spoken).
• Ability to work in an international, multicultural environment and travel up to 20%.

Required skills

• Process validation
• Test method validation
• Equipment qualification
• Knowledge of ISO 13485
• Knowledge of FDA 21 CFR Part 820