Applies skill and dexterity in the preparation of raw tissue materials for the manufacturing process, in keeping with regulatory and company guidelines
Key Responsibilities:
- Identify portions of tissue that meet thickness and other specification requirements of various product components, using forceps and gauges; primarily in a single dedicated area
- Visually assess leaflets to select those that meet manufacturing requirements, using forceps
- Operate fixation machine to convert incoming tissue to fixed tissue to begin preparation for manufacturing process
- Visually assess incoming pericardial tissue for obvious imperfections, using scalpels, forceps, scissors
- Operate die cut machine to produce individual leaflets
- Review, follow and perform job functions in compliance with established work instructions/process sheets and adherence with SOPs, including recording traceable information on device history records.
- On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period
- Other incidental duties: Clean and sanitize work area – surfaces and equipment – between processing of tissue lots
Education and Experience:
H.S. Diploma or equivalent Previous sewing, GMP, clean room, medical device experience Preferred
knowledge of elementary math Required
Additional Skills:
- Basic computer skills required
- Good communication skills required
- Able to read, comprehend and speak English
- 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, including with peers in manufacturing
- 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
- Candidate will be required to pass basic English skills assessment
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $37,000 to $50,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
About Edwards Lifesciences
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
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.
For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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Family and Medical Leave Act (FMLA)
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