Job Description

Position: Quality Engineer II , Req#: 9834-1

Location: Irvine, CA (100% Onsite)

Duration: 12+ Months Contract

Job Description:

What does your group do? Component & Supplier qualification for THV delivery system and implant devices.

Does your team use any specific technology/software you want us to look out for? MS Office, Keyence, Smartscope, SolidWorks, Minitab, PowerBI

What will a typical workday look like? Meeting with cross-functional team members, component drawing reviews developing inspection methods & fixturing, reviewing/analyzing data, tracking & reporting on status, validation protocol/execution/reports – for fixtures & test methods, supplier meetings, supporting supplier process validations, supporting receiving inspection issues (MRBs, NCRs, etc.), creating & releasing qualification reports, inspection measurement plans, SOPs, inspection process sheets

What will the work schedule be? Can any overtime be expected? Typical office hours: exact start and stop times can be flexible. This role will be full time onsite at the Irvine campus.

What specific product would this person be working on? The first device is a novel highly complex (>50 parts) system inclusive of a delivery system and a permanent implant. They need to be able to apply the first principles of engineering and understand how material properties impact stress and strain response, they have to understand tolerance stack-up and how to design for anticipated production variance.

What are your top 3 required technical skills? Must haves? Project & time management/organization/planning, Minitab/data analysis, problem solving

What are nice to have skills? Inspection development, Risk management, SolidWorks/Creo, Six Sigma

The main function of a quality engineer is to research and test the design, functionality and maintenance of products, equipment, systems and processes and develop quality standards. A typical quality engineer has the ability to read and interpret blueprints and evaluate product integrity and standards.

Education and Experience:

• Bachelor's degree in engineering required.
• 2-4 years of experience required.

Additional Skills:

• Creativity, verbal and written communication skills, analytical and problem-solving ability.
• Team player and detail-oriented.
• Basic ability to read and interpret blueprints, technical drawings, schematics and computer-generated reports.
• Previous experience with computer applications and software related to the engineering field, such as Computer Aided Design (CAD).

Job Responsibilities:

• Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
• Establishes program to evaluate precision and accuracy of production equipment and testing, measurement, and analytical equipment and facilities.
• May write training material and conduct training sessions on quality control activities.
• May specialize in areas of quality control engineering, such as design, incoming material, process control, product evaluation, product reliability, inventory control, metrology, automated testing, software, research and development, and administrative application.

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