Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives. Assesses Receiving... more details
Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.
Assesses Receiving Components to confirm conformity to specifications, ensuring regulatory and company guidelines have been met and devices meet operational standards as designed.
How you'll make an impact:
• Perform visual, dimensional, and functional inspection of components and devices using a wide variety of all applicable instruments tools, and equipment, such as magnifying lamp, microscope, vision inspection system, calipers, etc., to ensure conformance with design specifications, working independently at the highest levels of productivity
• Perform verification of receiving documents with component and device drawings to ensure requirements are met, including drawings that use Geometric Dimensioning and Tolerancing methodologies.
• Navigating through digital documentation and inspection processes and supporting the development of digital inspection/documentation methods.
• Review, follow, and perform job functions in compliance with established work instructions (i.e., routers) and adherence with SOPs, including recording traceable information on device history records and entering information into JDE.
• Control inventory to ensure appropriate storage conditions and movement, as well as ensuring correct labeling of product status.
• Provide coaching and training to lower level employees, evaluate and demonstrate correct approach on work of other employees; able to fill-in for Lead as needed
• Train colleagues from other sites, including inspection of their work output
• Other incidental duties: General work area housekeeping, attend training for new processes and procedures
What you'll need (Required):
4 years of medical device assembly experience is Required and
H.S. Diploma or equivalent years of experience
Associate degree is preferred.
What else we look for (Preferred):
• Ability to use applicable instruments and equipment, hand eye coordination, and high manual dexterity
• Full understanding of applicable inspection procedures, including the ability to contribute to the development of procedures
• Proficient in all inspection techniques for receiving inspection
• Ability to clearly describe and convey nonconformance issues, and enter them into QMS (Quality Management System)
• Ability to support inspection routine programming and contribute to the validation of automated test equipment
• Ability to effectively provide and accept feedback from colleagues on independent data verification and follow up with colleagues to ensure understanding
• Ability to provide feedback on product defects and follow through to establish resolution
• Strong communication and interpersonal relationship skills, including ability to convey training in methodology and procedures
• Able to read, comprehend, speak, and write English
• Good computer skills, required, including working knowledge of manufacturing software
• Strict attention to detail
• 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
• Work in a Team environment, and may work on inter-departmental teams
• 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 $48,000 to $66,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.