Edwards Lifesciences Calibration Tech in Shannon, Ireland
The Company: Edwards Lifesciences is driven by a passion to help patients. The company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives.
The Role : Perform routine and special calibration of all equipment/test and instruments measurement included in the calibration system to effectively meet the requirements and specifications in the General Calibration Procedure.
• Plan and perform complex calibration of equipment with certifications and/or training in temperature and electronics and ensure all calibration documentation are entered into system and in compliance, including the review of calibration, Preventive Maintenance (PM) and First Article Inspection (FAI) reports
• Register (induct) new equipment and maintain all metrology equipment (calibration and preventive maintenance) in computerized maintenance management system (CMMS)
• Lead investigations of non-conformities in different systems. Coordinate with service providers and custodians for calibration. Participate in the development and implementation of calibrations processes and procedures, including identifying opportunities for modification and making recommendations.
• Verify calibration report meets the calibration requirements as stated in asset record or by standards, and escalate any discrepancies
• Lead Out-of-Tolerances (OOT) investigations for metrology equipment and propose corrective actions
• Assigned CMMS Superuser (e.g Blue Mountain, Maximo) and provide training and technical expertise to all other users
• Research specifications for complex equipment and propose usage; Research, develop, and validate calibration test fixtures and procedures.
• Provide coaching and guidance to technicians and other users
• Monitor and ensure all metrology laboratory requirements are met
• Other incidental duties (e.g Participate in 6s activities).
Education and Experience:
Diploma or equivalent 8 Years years experience experience in measurement and calibration of equipment/instruments Required
Associate's Degree or equivalent in or completed technical/vocational school program from a recognized institution in electric, mechanical, electronics, and/or metrology Preferred
• Good communication skills, including the ability to convey instructions and training, and effectively persuade and negotiate to drive achievement of objectives
• Able to read, comprehend, write and speak English
• Excellent computer skills, including MS Office and advanced proficiency in CMMS (e.g Blue Mountain, Maximo)
• Full knowledge of calibration of manufacturing equipment and usage of hand tools, electronic monitoring equipment, fluid and pressure monitoring equipment
• Ability to utilize computerized maintenance management system
• Knowledge of calibration regulations and standards
• Substantial knowledge of SI Base Units (length, mass, time, electric current, thermodynamics temperature, amount of substance, luminous intensity)
• Ability to perform complex troubleshooting
• Ability to identify problems and relevant issues in complex situations, assessing using standard procedures
• Ability to use a wider range of IM&TE (Inspection, Measurement, and Test Equipment)
• Ability to read and understand procedures, drawings, schematics and carry out assembly instructions
• Knowledge and understanding of statistical techniques and procedures
• Ability to utilize CAD/drafting software (if applicable)
• Knowledge and understanding of ECR software systems (if applicable)
• Ability to draft technical documents (i.e, manufacturing and testing procedures)
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Strict attention to detail
• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
• Must be able to work in an inter-departmental team environment, as well as with colleagues from other departments
• Ability to provide feedback in a professional, direct, and tactful manner
• Represents the organization to outside contacts, i.e., vendors
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.