Maintenance Engineer
- Plaine Wilhems
- Negotiable
- Permanent
- Added 02/10/2025
- Closing 01/11/2025
- Mrs. Marie Annaëlle PERREAU
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Natec Medical Ltd is an integrated design, development and manufacturing company specialized in Percutaneous Interventional Medical Devices for the global market.
The main purpose of a Maintenance Engineer is to ensure that all manufacturing equipment, utilities, and systems used in the production of medical devices are operating reliably, efficiently, and in compliance with strict regulatory standards (such as FDA, ISO 13485, and GMP) & drive continuous improvement initiatives.
- Ensure that critical manufacturing and testing equipment is available and functioning at all times.
- Perform preventive and predictive maintenance to reduce equipment failures.
- Maintain documentation and validation records in accordance with regulatory requirements.
- Ensure equipment is calibrated, qualified (IQ/OQ/PQ), and maintained per defined schedules.
- Prevent equipment-related deviations or malfunctions that could impact product quality or patient safety.
- Troubleshoot issues quickly and effectively to avoid product defects or contamination.
- Identify and implement improvements to increase equipment efficiency, extend asset life, and reduce costs.
- Collaborate with process engineers, quality, and production teams on continuous improvement.
- Maintain accurate maintenance logs, calibration records, and service histories.
- Participate in audits and support root cause investigations for equipment-related non-conformances.