Edwards Lifesciences Sr. Assembler, Winding in Anasco All Locs, Puerto Rico
Applies skill and dexterity in the assembly of components into finished devices, in keeping with regulatory and company guidelines.
• Use the range of most highly complex tools and equipment - which may include one or more of the following welders, solders, ovens, autoclaves, microscopes, magnifiers, scissors, knives, or others - for assembly operations that typically require 40+ hours of training and including packaging/labeling in the manufacturing process of medical device components
• Self-assessment of work, which may include visual inspection under a microscope, and sequential review of colleagues work, providing constructive team feedback, based on SOPs and quality guidelines; including escalating work issues and changes in equipment performance to supervisor for assessment and correction, including reworking units as required.
• Assure appropriate settings and parameters of equipment for precise assembly and inspection of medical devices, in a timely fashion at each work station, following work order instructions and drawings, using computers to navigate drawings, and entering parts status data.
• Inventory reconciliation at start of day and when transitioning to next work order.
• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and may enter information into JDE.
• Provide coaching and training to lower level employees, monitor the line performance, evaluate and demonstrate correct approach on work of other employees, during the certification process
• On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period
• Other incidental duties: General work area housekeeping, attend trainings, meetings, special assignments and other miscellaneous tasks, perform other duties as assigned by Supervisor
Education and Experience:
H.S. Diploma or equivalent with 4 years of previous related experience, and experience in Winding and/or Bonding, required. Previous experience working in a manufacturing environment, preferred.
• Full understanding of manufacturing procedures with proven capacity to learn and work on all operations for a wide array of models
• Proven ability to complete, retain, and incorporate training coursework in the performance of new and advanced work procedures
• Excellent communication and interpersonal relationship skills, including ability to convey training in methodology and procedures
• Able to read and comprehend English, and elementary-level understanding of numerical functions (this was in our career continuum meeting, is this applicable?)
• Able to read and comprehend English sufficiently to determine system work order status (this was in the first job description and is repetitive in the above bullet. Please let me know which is applicable?)
• Basic computer and mathematics skill (this was in the first job description, is this applicable?)
• Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Must be able to work with minimum supervision by following detailed manufacturing instructions
• Work in a Team environment, primarily with colleagues and supervisor and may also work on inter-departmental teams
• Flexibility to work overtime and varying shifts
• Accountable to adhere to applicable Edwards Environmental, Health and Safety and Quality System requirements to ensure our products and services consistently meet customer and regulatory
• 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
• Ensure proper handling, storage and disposal of all waste generated in the facility according to applicable laws within the waste management program (RCRA). Prepare regulatory and/or internal reports, complete waste determinations, sign waste manifests and coordinate proper training sessions to affected personnel
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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.