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:
• The hours for this role are Monday-Friday 4:30am-1:00pm.
• Performing visual, dimensional, and functional inspection across all components and/or finished medical device products using a wide variety of all applicable tools and equipment such as magnifying lamp, microscope, vision inspection system, etc. to ensure conformance with design specifications - working independently at the highest levels of productivity.
• Performing functional testing of finished medical device products using both automated and manual valve testing equipment to ensure conformance with design specifications.
• Reviewing, following and performing 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.
• Performing verification of manufacturing documents with component and device drawings, which may include Geometric Dimensioning and Tolerancing methodologies.
• May control inventory to ensure appropriate storage conditions and movement.
• Training colleagues from other sites, including inspection of their work output.
• Providing coaching and training to lower level employees, evaluating and demonstrating correct approach on work of other employees, able to fill-in for Lead as needed.
• Other incidental duties: General work area housekeeping.
What you'll need (Required):
• 4 years of related experience required.
• Due to the specific duties of this job, you must be able to read, comprehend, write, and speak English.
• Good computer skills, required, including working knowledge of manufacturing software.
• Candidate will be required to pass basic English skills assessment.
What else we look for (Preferred):
• H.S. Diploma or equivalent medical device assembly (Preferred).
• Ability to use applicable tools 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 production inspection.
• Ability to clearly describe and convey nonconformance issues, and enter them into QMS (Quality Management System).
• Ability to program and contribute to the validation of automated test equipment.
• Ability to provide feedback on product defects and may follow through to establish resolution.
• Strong communication skills and interpersonal relationship skills, including ability to convey training in methodology and procedures.
• 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.
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 $49,000 to $67,000 (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.