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

How you'll make an impact :

Performing visual, dimensional, and functional inspection across all components and devices using a wide variety of all applicable tools and equipment such as magnifying lamp, microscope, vision inspection system, thickness gauges, etc.

to ensure conformance with design specifications - working independently at the highest levels of productivity

• Reviewing, following and performing job functions in compliance with established work instructions (i.e. Routers, Standard Operating Procedures, Drawings, Protocols, etc) to ensure product requirements are met using paper or digital systems.
• Navigating through digital documentation and inspection processes and supporting the development of digital inspection / documentation methods
• Maintaining accurate records, data entries, and product disposition results within Device History Records and digital systems.
• Controlling inventory to ensure appropriate storage conditions, movement and correct labeling of product status
• Providing coaching and training to lower level employees, evaluate and demonstrate correct approach to work with other employees, able to fill-in for Lead as needed
• Training colleagues from other sites, including inspection of their work output
• Other incidental duties : General work area housekeeping, attend training for new processes / procedures, and performing minor data analysis

What you'll need (Required) :

4 years experience related experience Required and

H.S. Diploma or equivalent medical device assembly Preferred

Associate Degree 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 medical device product inspection
• Ability to clearly describe and convey nonconformance issues and enter them into QMS (Quality Management System)
• Ability to support inspection method validation and digitalization of the existing Inspection processes.
• 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, provide / own ideas on improving existing processes and follow through to establish resolution
• Strong communication and interpersonal relationship skills, including the 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.

ForCalifornia, 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.

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.

Last updated : 2024-05-22