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 SolidWorksFamiliarity 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.