Applies skill and dexterity in the operation of a variety of types of machinery in the manufacturing process, in keeping with regulatory and company guidelines.
Key Responsibilities:
Set up and calibrate equipment and machinery; and operate one of a wide (at least 2) variety of equipment – housing, injection molding, form fill and seal flow tester packaging machinery, etc – in the manufacturing process of medical devices, including equipment set-up and adjustments throughout the production process to ensure appropriate settings and parameters to achieve product design and quality specifications, while maintaining a stable and effective process.
Select and utilize the associated equipment manufacturing fixtures/aids – cutting dies, flexographic plates, or any other required fixture associated with assigned operation/task.
Review, follow and perform job functions in compliance with work instructions and adherence with SOPs, including recording traceable information on device history records and enter information into JDE.
Perform inspections of machinery and output to ensure the processes are being executed in conformance with production specifications, including using measurement devices to ensure seal widths are in compliance
Ensure automated recording of parameters
Troubleshoot equipment and escalate issues
Self-inspection of work output, including making basic corrections in machine set-up and placement of tools in machines
Act as a resource to entry level operators providing training, information, and guidance as requested and needed
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, providing defect-free documentation
Education and Experience:
H.S. Diploma or equivalent 2 years experience related experience in using similar machinery Required.
Experience in Injection Molding of Medical Device, Preferred
Experience using JSW Injection Molding Machines, Preferred
Additional Skills:
Ability to use a variety of manufacturing equipment for multiple machine operations and fixtures (at least 2)
Good level of understanding of manufacturing procedures
Basic computer skills, preferred required; working knowledge of JDE and RFSMART
Strong knowledge of machine operations
Good communication skills
Open to receiving and giving team performance feedback
Able to read and comprehend English
Knowledge of and adherence 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 departmental colleagues and supervisor, exchanging information related to performing required tasks
Strict attention to detail
Proven ability to complete, retain, and incorporate training coursework in the performance of new and advanced work procedures
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.
