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Reliability Engineer
Reliability EngineerInnovative Career Resource • Irvine, CA
Reliability Engineer

Reliability Engineer

Innovative Career Resource • Irvine, CA
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  • [job_card.full_time]
[job_card.job_description]

An internationally recognized, Top Place to Work–nominated Orange County medical device and technology company is actively hiring a Reliability Engineer to join its rapidly growing and highly innovative organization.

This is an exciting opportunity to make an immediate impact within a company at the forefront of orthopedic technology. The organization  is dedicated  to the research, development, and manufacturing of  cutting-edge , hip and knee replacement surgeries—including total hip, total knee, partial knee, and revision procedures.

The qualified professional will be  responsible  for, but not limited to :

  • Conduct ing  review s  and testing at key stages of product and development for product liability and performance , compliance with regulatory standards, engineering principles, and customer requirements and related specifications.
  • Support ing  the development of test methods, test method validation, collection of data, and report writing.
  • Collaborat ing  closely with design and quality engineering to develop strategies, plans and specific methods for system level electromechanical  testing .
  • Write protocols to support testing objectives in collaboration with design and quality engineers.
  • Document the manufacture and inspection of test products in compliance with the company’s quality system.
  • Prepare, set up, and conduct experiments and tests related to both test methods and product testing.
  • Conduct root cause investigations  and analyses and   writes  supporting reports.
  • Build and se t  up test and assembly equipment.
  • Make and build models and fixtures using assembly techniques and fabrication skills for electromechanical  devices.
  • Manage change orders, controlled document release and revisions.

Requirements

  • Bachelor’s  Degree in  Mechanical Engineering ,  Industrial Engineering  or similar with 3-5 years  of   hands-on  industry experience working in Medical Device.
  • E xperience with mechanical stress testing, fatigue analysis, and failure investigation for precision electromechanical systems.
  • Foundational understanding of reliability modeling, life data analysis, and  D esign for  R eliability (DfR) in medical device applications.
  • Proficiency  in SolidWorks
  • Familiarity with structured problem-solving tools such as 5 Whys, Fishbone Diagrams, and Fault Tree Analysis (FTA).
  • Ability to assist in the development and execution of test protocols for mechanical components and assemblies.
  • Working knowledge of statistical analysis techniques including Weibull analysis and capability studies using software such as Minitab.
  • Exposure to medical device standards and regulations including ISO 13485, ISO 14971, and FDA 21 CFR Part 820, with emphasis on mechanical reliability requirements.
  • Ability to d emonstrate a methodical approach to problem-solving and data interpretation.
  • Capab ility  of clearly conveying technical information to cross-functional teams and stakeholders.
  • Ability to work  within multidisciplinary teams including R&D, Quality, and Manufacturing.
  • To p roactively seek  opportunities to gain experience  and contribute to continuous improvement efforts.
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