Key Responsibilities:
Preventive Maintenance:
- Develop and implement preventive maintenance schedules to minimize equipment downtime.
- Perform routine inspections and identify potential issues before they escalate.
Equipment Repair:
- Diagnose faults in mechanical, electrical, and electronic systems.
- Conduct repairs or coordinate with external specialists for complex fixes.
Compliance and Documentation:
- Ensure all maintenance activities comply with medical device manufacturing standards (e.g., ISO 13485, FDA).
- Maintain accurate records of maintenance work, including logs, calibration certificates, and validation reports.
Machine Calibration and Validation:
- Perform regular calibration and validation of equipment to maintain production quality.
- Collaborate with the Quality Assurance team to ensure compliance with industry regulations.
Technical Support:
- Provide technical support to the production team for machine setup and operation.
- Train staff on proper equipment handling and troubleshooting procedures.
Qualifications and Skills:Educational Background:Bachelor’s degree in Mechanical, Electrical, Mechatronics Engineering, or a related field.Experience:3+ years of maintenance experience in a medical devices or regulated manufacturing environment is preferred.Technical Skills:Knowledge of GMP, ISO 13485, and FDA standards.Proficiency in troubleshooting mechanical, electrical, and control systems.Familiarity with PLC systems and automated machinery.Soft Skills:Strong problem-solving and analytical abilities.Excellent communication and teamwork skills.Attention to detail and a proactive mindset.