Assesses devices in-process and upon completion to ensure regulatory and company guidelines have been met and devices meet operational standards as designed.

　　Key Responsibilities:

　　• Perform visual, dimensional, and functional inspection of more complex components and/or finished medical device products using a wide variety of tools and equipment such as magnifying lamp, microscope, vision inspection system, etc. to ensure conformance with design specifications – working at a level of greater independence with a higher level of productivity.

　　• Perform functional testing of finished medical device products using both automated and manual valve testing equipment to ensure conformance with design specifications

　　• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and may enter information into JDE.

　　• Perform verification of manufacturing documents with component and device drawings

　　• May control inventory to ensure appropriate storage conditions and movement

　　• Other incidental duties assigned by leadership: May train colleagues from other sites, including inspection of their work output .On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period

　　Education and Experience:

　　2 years years experience of previous related experience Required

　　H.S. Diploma or equivalent Previous medical device assembly experience Preferred

　　Additional Skills:

　　• Ability to use applicable tools and equipment, hand-eye coordination, and high manual dexterity

　　• Full understanding of applicable inspection procedures

　　• Continuously expands proficiency in inspection techniques

　　• Ability to clearly describe and convey nonconformance issues, and enter them into QMS (Quality Management System)

　　• Resolves routine issues with senior staff for supervisory guidance and approval

　　• Good communication skills

　　• Strict attention to detail

　　• Must be able to work in a team environment

　　• Ability to effectively provide and accept feedback from colleagues

　　• Provide feedback on product defects and may follow through to establish resolution.

　　• Able to read, comprehend, speak, and write English

　　• Basic computer skills required, including working knowledge of manufacturing software

　　• 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.

　　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 15,000 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.