Applies skill and dexterity in the preparation of raw materials work-in-process (WIPs) semi-finished and finished goods for the manufacturing process in keeping with regulatory and company guidelines.
Key Responsibilities:
Operate all equipment in the manufacturing process of medical devices which may include ultrasonic cleaners tissue deflectors or others in the manufacturing process of medical devices - including assuring appropriate settings and parameters while working independently at the highest levels of quality and productivity
Select setup and utilize the associated equipment manufacturing fixtures/aids such as jigs cutting dies templates or any other required fixture associated with assigned operation/task
Strong trouble shooting abilities and systems understanding to investigate and resolve inventory discrepancies
Assess and select tissue leaflets that meet acceptable quality standards
Perform component transfers as required maintain integrity of JDE and MES system at all times.
Review follow and perform job functions in compliance with established work instructions and adherence with SOPs including recording traceable information on device history records which may include entry into JDE MES and any other systems including issuing materials terminate work orders as required
Provide coaching and training to lower level employees in the absence of the Lead Trainer or Group Leader
Unload tools/components/manufacturing aids from ovens/autoclaves. Print distribute routers for tissue processing and partner with Engineering on the tissue/components processing aspects of new products transfer.
Other incidental duties: General work area housekeeping
Education and Experience:
Secondary Education 4 years previous related experience in GMP clean room medical device experience Required
Additional Skills:
Ability to use virtually all manufacturing equipment related to the full array of machine operations and fixtures hand eye coordination and high manual dexterity
Advanced level of understanding of manufacturing procedures
Successful completion of ongoing job training of manufacturing process steps
Ability to read comprehend and speak English and good communication skills required
Good computer skills (tablet/ Surface Pro) required; working knowledge of JDE and RFSMART
Ability to guide other workers/colleagues in understanding operations and manufacturing standards
Ability to effectively provide and accept feedback from colleagues based on performance
Proven ability to complete retain and incorporate training coursework in the performance of new and advanced work procedures
Must be able to work in a team environment primarily with departmental colleagues and supervisor exchanging information and methodology related to performing required tasks and with minimum supervision by following detailed established operating instructions
May also work on inter-departmental teams and with other departments including engineering and/or maintenance
Successful completion of ongoing job training of manufacturing process steps
Adhere to all company rules and requirements (e.g. pandemic protocols Environmental Health & Safety rules) 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
Required Experience:
Senior IC
Edwards Lifesciences (NYSE: EW), is the global leader of patient-focused medical innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakehol ... View more