Applies skill and dexterity in the assembly of components into finished devices, in keeping with regulatory and company guidelines.
Key Responsibilities:
Use higher level tools and equipment - which may include one or more of the following welders, solders, ovens, autoclaves, microscopes, magnifiers, scissors, knives, or others - for more complex assembly operations that typically require 20+ hours of training 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.
On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period
7. 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. 2 years of previous related experience, required.
Previous experience working in a manufacturing environment and Thrombectomy Operations, preferred
Additional Skills:
Good understanding of manufacturing procedures and continuously expands proficiency in all operations for multiple models
Proven ability to complete, retain, and incorporate training coursework in the performance of new and advanced work procedures
Good communication skills
Able to read and comprehend English, and elementary-level understanding of numerical functions
Basic computer and mathematics skill
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
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
E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
