Full Job Description
Job Function:
Quality
Job Sub Function:
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Irvine, California, United States of America
Job Description:
Employer: Biosense Webster, Inc.
Job Title: Senior Quality Engineer
Job Code:
Job Location: Irvine, CA
Job Type: Full-Time
Rate of Pay: $140,774 - $149,220
Job Duties: Lead Quality Engineering for the New Product Development Core team developing new technologies for the treatment of various cardiac arrhythmias. Responsible for design verification and validation activities for device in development. Support the development of design solutions. Perform complex tests and analyses to ensure that products are aligned with established specifications. Perform statistical analysis of data generated, including but not limited to: process capability, Cpk, Ppk, Gauge R&R, ANOVA, Sample Size determination, and variable/attribute data analysis against predetermined acceptance criteria. Compile data and prepare reports on findings, to identify trends and propose corrective action as needed. Recommend and implement revisions, corrections, and changes to applicable test equipment, procedures, and methods. Troubleshoot defective products during the development and testing phases. Perform risk management activities to prevent unforeseen failure modes and improve the capacity of the processes, including FMEAs (Design, Application, Process). Utilize output, confidence, and reliability to determine appropriate sample size for product verification testing. Perform, review, and approve component qualifications, drawings, and work instructions. Create, revise and approve Engineering Change Orders (ECOs) and Change Notices (CNs) on cPDM/Windchill for device/component/sub-assembly specifications, and for work/process instructions in pre-production and at production level.
Requires up to 20% travel (domestic & international). May telecommute 2 days per week.
Requirements: Employer will accept a Master's degree in Biomedical Engineering or related field and 4 years of experience in the job offered or in a Senior Quality Engineer-related occupation.
This job posting is anticipated to close on 7/21/2026.
Required Skills:
Preferred Skills:
