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**Job Function: **
Quality
**Job Sub Function: **
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Irvine, California, United States of America
Job Description:
RELIABILITY MANAGER:
The Reliability Manager leads initiatives to ensure medical devices meet lifetime and safety expectations. The individual will analyze data to predict failures, drive corrective actions, and lead a team of engineers to build a "zero defect" culture. The role focuses on improving reliability through rigorous testing, data-driven analysis, and close collaboration with product teams, engineering, and suppliers to ensure parts meet performance standards and deliver long-term customer satisfaction.
Responsibilities
• Develop and implement multi-year reliability strategies, including Design for Reliability (DfR) in R&D and post-market, to improve product robustness.
• Develop and implement early-life testing programs using engineering methodologies to identify components that may fail prematurely.
· Oversee reliability testing, including environmental, thermal, shock, vibration, and lifecycle tests. Devises methods for inspecting and evaluating product precision.
• Apply statistical techniques and engineering analysis (Weibull analysis, regression, capability analysis) to evaluate failure data, detect early-life issues, and drive product quality improvements.
• Collaborate with R&D, product quality teams, and suppliers, leveraging statistical data analysis and engineering expertise to enhance medical device reliability during the early-life phase.
• Analyze large volumes of data, applying self-learning approaches to transform raw information into actionable insights. • Serve as a single source of truth for data interpretation, collaborating with multiple teams to ensure consistent understanding.
• Ensure all products, processes, and documentation comply with FDA cGMP, ISO 13485, and other regulatory bodies.
• Lead a team of reliability engineers and technicians, partnering with R&D, manufacturing, quality, and regulatory teams.
Requirements
Bachelor’s degree in Mechanical, Biomedical, Electrical, or Reliability Engineering (Master’s or PhD preferred).
- Experience: 5–10+ years of reliability engineering experience in a regulated medical device or high technical R&D/Manufacturing environment. 3+ years of experience in a reliability management position
- Technical Skills: Strong knowledge of end-to-end reliability engineering and testing methods (HALT/HASS, accelerated life testing), statistical techniques.
- Familiarity with Reliability analysis tools such as Reliasoft, Minitab
- Familiarity with Data Analytics tools such as Tableau
- Strong collaboration and communication skills.
- Problem-solving and strategic thinking.
- Ability to lead cross-functional initiatives.
Required Skills:
Preferred Skills:
Business Alignment, Coaching, Collaborating, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility
The anticipated base pay range for this position is :
$102,000.00 - $177,100.00
Additional Description for Pay Transparency:
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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits