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 a variety of manufacturing equipment, which may include , ultrasonic cleaners, tissue deflectors, or others, in the manufacturing process of medical devices - including assuring appropriate settings and parameters
• Select and utilize the associated equipment manufacturing fixtures/aids, such as jigs, cutting dies, templates, or any other required fixture associated with assigned operation/task
• 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 and any other systems, including issuing materials, terminate work orders, as required
• Perform component transfers as required, maintain integrity of JDE and MES system at all times.
• Perform fixtures sanitization per procedure.
• Unload tools/components/manufacturing aids from ovens/autoclaves.
• Maintain accurate inventory in JDE and MES and ensure the quantity tallies with physical count.
• Other incidental duties: General work area housekeeping, general sanitization of work area with approved chemicals, material handling, printing
Education and Experience:
Secondary Education with previous GMP, clean room, medical device experience Preferred
No previous related experience Required
Additional Skills:
• Ability to use a variety of manufacturing equipment, hand eye coordination, and high manual dexterity
• Basic 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
• Basic computer skills (tablet/Surface Pro), preferred
• Ability to effectively provide and accept feedback from colleagues based on performance
• Must be able to work in a team environment, primarily with departmental colleagues and supervisor, and with minimum supervision by following detailed established operating instructions
• Strict attention to detail
• Trouble shooting abilities and systems understanding to investigate and resolve inventory discrepancies
• 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
Top Skills
What We Do
Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more.
Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today.
Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives.
Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life.
For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms
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