Reliability Engineer

OrthAlign, Inc., a Smart Technology, growing medical device company, has an immediate opening for a Reliability Engineer responsible for supporting development and testing of new products and components and changes to existing products and components. This position interacts directly with design and operations engineering and design quality, as well as third-party test firms.

You will:

• Conduct review and test at key stages of product development for product reliability and performance, compliance with regulatory standards, engineering principles, company procedures and policies, customer requirements and related specifications.
• Be the responsible party for the development of reliability test methods, test method validation, collection of data, and report writing.
• Collaborate closely with design and quality engineering to develop strategies, plans and specific methods for system level, electromechanical testing.  Priority focus on reliability and accuracy.
• Write protocols to support testing objectives in collaboration with design and quality engineers.
• Collaborate with Quality and Design Engineering, to identify and understand relevant standards to ensure scope of testing is in compliance.
• 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.
• Design and build models and fixtures using assembly techniques and fabrication skills for electromechanical devices.
• Create, read and understand CAD drawings.
• Manage change orders, controlled document release and revisions.

You need:

• Your BA/BS Engineering-oriented degree and 5+ years of experience in medical device manufacturing.
  
  

Technical Competencies

• Mechanical Testing & Analysis: Basic experience with mechanical stress testing, fatigue analysis, and failure investigation for precision electromechanical systems.
• Reliability Engineering Principles: Foundational understanding of reliability modeling, life data analysis, and design for reliability (DfR) in medical device applications.
• CAD & Simulation Tools: Proficient in SolidWorks.
• Root Cause Analysis: Familiarity with structured problem-solving tools such as 5 Whys, Fishbone Diagrams, and Fault Tree Analysis (FTA).
• Design Verification Support: Ability to assist in the development and execution of test protocols for mechanical components and assemblies.
• Statistical Methods: Working knowledge of statistical analysis techniques including Weibull analysis and capability studies using software such as Minitab.
• Regulatory Awareness: Exposure to medical device standards and regulations including ISO 13485, ISO 14971, and FDA 21 CFR Part 820, with emphasis on mechanical reliability requirements.
  
  

Soft Skills

• Analytical Thinking: Demonstrates a methodical approach to problem-solving and data interpretation.
• Effective Communication: Capable of clearly conveying technical information to cross-functional teams and stakeholders.
• Team Collaboration: Works effectively within multidisciplinary teams including R&D, Quality, and Manufacturing.
• Adaptability: Thrives in dynamic environments and adjusts to evolving project needs and priorities.
• Attention to Detail: Maintains high standards in documentation, testing, and analysis to ensure product safety and compliance.
• Initiative & Curiosity: Proactively seeks opportunities to learn and contribute to continuous improvement efforts.

We offer:

• Competitive compensation including bonus and equity
  
• Opportunities for career advancement
• Full benefits package including 401(k) and voluntary benefit offerings
  
• An evolving, engaging culture and workplace
• Nominated by our employees as a Top Place to Work in Orange County!

 It is an exciting time at OrthAlign - make your next career move with us!

NOTE:  We are unable to provide any type of sponsorship at this time.