Senior Quality Engineer
Top focus
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All Job Posting Locations: Irvine, California, United States of America Job Description: Employer: Biosense Webster, Inc. Job Title: Senior Quality Engineer Job Code: A011.5775 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 . Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement.
- For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits Required Skills: Preferred Skills: