Summary The Equipment Maintenance/Calibration Technician is responsible for the set-up, installation, maintenance and support of automated equipment ensuring optimum performance and the achievement of test operational goals.
The Equipment Maintenance/Calibration Technician works closely with teams to resolve test/manufacturing issues and constraints while implementing safe and robust solutions to improve overall efficiency through improvement projects around run rate increase, cycle time gains, yields and quality.
Detailed Description: Perform calibration, maintenance, and repair of electronic, mechanical, and pneumatic test and measurement equipment according to established procedures and standards.
Maintain accurate calibration records, including calibration data, equipment history, and maintenance logs.
Identify and troubleshoot equipment malfunctions and perform necessary repairs or adjustments.
Ensure all calibration activities comply with ISO 13485, FDA regulations (21 CFR Part 820), and other applicable standards.
Develop and update calibration procedures and work instructions as needed.
Coordinate with internal departments to schedule calibration activities and minimize equipment downtime.
Manage and maintain calibration standards and reference equipment.
Assist in the procurement and validation of new test and measurement equipment.
Participate in internal and external audits related to calibration activities.
Provide technical support and training to other personnel on calibration procedures and equipment operation.
Maintain a clean and organized work area.
Knowledge/Skills/Competencies Engineering degree or technical certification in electronics, instrumentation, or a related field.
Proven experience as a Calibration Technician, preferably in a medical device or regulated industry.
Strong knowledge of calibration principles, techniques, and standards.
Proficiency in using calibration software and equipment.
Familiarity with ISO 13485, FDA regulations (21 CFR Part 820), and other relevant standards.
Excellent troubleshooting and problem-solving skills.
Strong attention to detail and accuracy.
Ability to read and interpret technical drawings and schematics.
Excellent written and verbal communication skills.
Ability to work independently and as part of a team.