Senior Quality Engineer

Johnson & Johnson Innovative MedicineIrvine, CA
$140,774 - $149,220Hybrid

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Requirements

  • 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.

Responsibilities

  • 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.

Benefits

  • Consolidated retirement plan (pension)
  • Savings plan (401(k))
  • Long-term incentive program
  • Vacation –120 hours per calendar year
  • Sick time - 40 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 period
  • Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year
  • Medical
  • Dental
  • Vision
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