Hardware Validation Engineer

Job Location US-AZ-Scottsdale
ID
2021-5738
# of Openings
1
Category
Manufacturing
Type
Direct Hire

Overview

As a key member of our client's Validation team, you will be essential in designing and planning test criteria to ensure products meet quality standards.

Responsibilities

  • Coordinate the implementation or scheduling of validation testing with affected departments and personnel.  
  • Direct validation activities, such as protocol creation or testing.  
  • Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.  
  • Draw samples of raw materials, intermediate products, or finished products for validation testing.  
  • Resolve testing problems by modifying testing methods or revising test objectives and standards.  
  • Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.  
  • Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for production of pharmaceuticals, electronics, or other products.  
  • Design validation study features, such as sampling, testing, or analytical methodologies.  
  • Recommend resolution of identified deviations from established product or process standards.  
  • Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.  
  • Maintain validation test equipment.  
  • Prepare detailed reports or design statements, based on results of validation and qualification tests or reviews of procedures and protocols.  
  • Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.  
  • Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.  
  • Study product characteristics or customer requirements to determine validation objectives and standards.  
  • Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions. 
  • Identifying measures or indicators of system performance and the actions needed to improve or correct performance, relative to the goals of the system. 
  • Analyzing needs and product requirements to create a design. 
  • Conducting tests and inspections of products, services, or processes to evaluate quality or performance. 

Qualifications

Basic Qualifications

  • Bachelor’s Degree 
  • Knowledge of the practical application of engineering science and technology. This includes applying principles, techniques, procedures, and equipment to the design and production of various goods and services. 
  • Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods. 

Preferred Qualifications

  •  Master’s Degree  
  •  Six Sigma Green or Black Belt certified  
  •  ASQ (American Society of Quality) certifications, such as CRE (Certified Reliability Engineer) 

Physical Demands

  • Spend Time Using Your Hands to Handle, Control, or Feel Objects, Tools, or Controls 
 

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