Sr Reliability Engineer, Quality

Johnson & Johnson Innovative Medicine•Irvine, CA

22h•$94,000 - $151,800

About The Position

The Reliability Engineer is responsible for ensuring medical devices meet lifetime, safety, and performance expectations through rigorous testing, data analysis, and cross-functional collaboration. This role focuses on identifying early-life failures, improving product robustness, and supporting design and manufacturing teams with data-driven reliability insights.

Requirements

Bachelor’s degree in Mechanical, Materials, Electrical, or Reliability Engineering (Master’s preferred).
5–10+ years of reliability engineering experience in a regulated medical device or high‑technology R&D/manufacturing environment.
Strong understanding of reliability engineering principles, including HALT/HASS, accelerated life testing, and failure analysis.
Proficiency with reliability analysis tools (e.g., ReliaSoft, Minitab).
Familiarity with data analytics tools such as Tableau.
Strong collaboration, communication, and technical problem‑solving skills.
Ability to work cross-functionally to support product development and continuous improvement activities.

Nice To Haves

Coaching
Consistency
Controls Compliance
Critical Thinking
Data Savvy
Engineering
Financial Competence
Good Automated Manufacturing Practice (GAMP)
ISO 9001
Lean Supply Chain Management
Leverages Information
Process Improvements
Quality Control (QC)
Quality Standards
Quality Systems Documentation
Quality Validation
Science
Technology
Engineering, and Math (STEM) Application
Technologically Savvy

Responsibilities

Execute reliability engineering activities across the product lifecycle, including Design for Reliability (DfR) in R&D and post‑market support.
Perform early‑life testing using engineering methodologies to identify components at risk of premature failure.
Conduct reliability tests such as environmental, thermal, shock, vibration, and lifecycle testing; develop test methods as needed to evaluate component and system durability.
Apply statistical techniques (e.g., Weibull analysis, regression, capability analysis) to evaluate failure modes, interpret test results, and support product quality improvements.
Collaborate with R&D, product quality, and supplier teams to assess reliability risks, review test data, and ensure components meet performance and robustness requirements.
Analyze large datasets and apply data‑driven approaches, including self‑learning or automated analytics, to convert raw reliability data into actionable insights.
Serve as a technical resource for data interpretation, supporting consistent understanding of reliability results across engineering and product teams.
Ensure all reliability activities, documentation, and test execution comply with FDA cGMP, ISO 13485, and other applicable regulatory requirements.
Support cross‑functional initiatives related to reliability improvement, corrective actions, and risk reduction.

Benefits

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.
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year