Applies knowledge of metrology and production line for class III implantable products, processes and associated equipment, performing routine and special calibrations for equipment and instruments to meet specifications.
Key Responsibilities :
Plan, perform complex calibration of equipment, and ensure all documentation is entered into system and in compliance, including the review, Preventive Maintenance.
Register (induct) new equipment and maintain all metrology equipment (calibration and preventive maintenance) in computerized maintenance management system
Provide technical support to operations team in metrology related issues. Maintain metrology system for all assets, PM schedules, job plans and routes.
Liaise with vendors for calibration / FAI capabilities and requests. Assist and support calibration assignment and scheduling with vendors and custodians.
Ensure that all manufacturing equipment is well maintained, equipment down time is minimized, equipment utilization is optimized and appropriate safety procedures are carried out.
Provide coaching and guidance to technicians and other users
Evaluate and assist in the equipment feasibility study, process development and equipment validation and revalidation activities.
Other incidental duties
Education and Experience :
Bachelor's Degree or Equivalent in in Engineering or Scientific field, 2 years years experience of experience including either industry or industry / education Required or
Additional Skills :
Full knowledge of calibration of manufacturing equipment and usage of hand tools, electronic monitoring equipment, fluid and pressure monitoring equipment
Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
Basic understanding of statistical techniques
Previous experience working with lab / industrial equipment required (if applicable)
Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
Solid problem-solving, organizational, analytical and critical thinking skills
Solid understanding of processes and equipment used in assigned work
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
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
Ability to build productive internal / external working relationships
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