Applies skill and dexterity in the performance of all aspects of device production, in keeping with regulatory and company guidelines; and provides training and guidance to co-workers.
Key Responsibilities:
• Expertly use and/or instruct others in the use of the full range of tools and equipment to complete assembly of medical devices at all work stations, - with proficiency in all operations for multiple models and other production areas (model/operation) and/or have in-depth capability in assigned operations - 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.
• Monitor and coach production line workers, providing feedback on quality of work and guidance to improve competency; may drive assembly team to achieve established mfg and quality metrics in the absence of the supervisor
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• Gather feedback from workers on production processes and formulate proposals for process improvement
• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records in JDE and other automated production systems
• Ensure assemblers on team are fully trained to perform assigned tasks, including those associated with revisions, including conducting training as deemed necessary
• Perform spot check verifications and work closely with new hires to review work in relation to specifications
• Escalate production and staff issues to supervisor
• Partner with quality to align on product defect determinations
• Other incidental duties: General work area housekeeping. May perform assembly as needed, e.g., relief breaks
Education and Experience:
H.S. Diploma or equivalent 2 years years experience of previous related experience required, specifically in GMP, clean room, medical device environment Required
Additional Skills:
• Demonstrated ability to lead teams, coach others, and transfer knowledge with at least 2 years previous related experience, which may include leading teams, working with GMPs, working in a clean room environment, and/or working in a medical device experience
• Excellent communication and interpersonal relationship skills, including ability to convey training in methodology and procedures
• Proven ability to complete, retain, and incorporate training coursework in the performance of new and advanced work procedures and/or in concentrated performance of assigned work procedures
• Computer proficiency, e.g., email, JDE, and electronic documentation systems
• Good hand eye coordination, required
• Strong English language skills, including reading, comprehending, speaking and writing
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Primarily work with colleagues and supervisor in a team environment, and may also work on inter-departmental teams
• Successful completion of ongoing job training of assembly 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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.