Edwards Lifesciences Lead Sewer in Cartago, Costa Rica
Applies skill and dexterity in the performance of all aspects of device production, in keeping with regulatory and company guidelines; and provides training and guidance to co-workers
Key Responsibilities: • Coach production line workers, providing feedback on quality of work and guidance to improve performance • Perform verifications, against specifications, of completed steps, and successive checks on steps completed by work team colleagues • Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records in JDE and other automated production systems • Use tools – needles, scissors, forceps, specialized tooling, microscope – for the purpose of teaching, coaching or training, to perform assigned steps in the sewing assembly of valves • Conduct training as deemed necessary, as confirmed with supervisor. Ensure assemblers on team are fully trained to perform assigned tasks, including those associated with revisions • Partner with Quality to align on product defect determinations • On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period • Other incidental duties (e.g. occasional photo copying or deliveries)
Education and Experience: H.S. Diploma or equivalent 2 years years experience of previous related experience, specifically in sewing, GMP, clean room, medical device environment Required
Additional Skills: • Demonstrated ability to lead teams, coach others, and transfer knowledge • Proficient computer skills, including MS Office Suite and/or manufacturing system (e.g., JDE, Maximo) • Strong English language skills, including reading, comprehending, speaking and writing, and good communication skills • Ability to use small hand tools, hand eye coordination, and high manual dexterity • Advanced level of understanding of manufacturing procedures • Proficient in all operations for multiple models and other production areas (model/operation) • Ability to guide other workers/colleagues in understanding operations and quality standards • 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 • Must be able to work in a team environment and with minimum supervision by following detailed manufacturing instructions • 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 13,000 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.