Manufacturing Quality Engineer

Company: Katalyst Healthcares & Life Sciences
Location: Andover
Posted on: January 26, 2023

Job Description:

Responsibilities:

• 
  
• Guided by customer feedback, identify and clearly articulate the customer and business opportunities
  
• Independently develop, design and implement product quality solutions to improve on-market product quality and services.
  
• Manage complex multi-functional projects that require project management leadership skills and delivery of business prioritized projects.
  
• Proactively monitor, attend focus groups, analyze, and improve all aspects of product performance.
  
• Solution development may include prototyping of instruments and implants which may require test method development and validation.
  
• Serve as a Customer Experience Champion and lead change management across functions and serve as a conduit to Commercial functions.
  
  
  Requirements:
  
  
  • 
    
  • Bachelor's Degree in Mechanical Engineering or equivalent scientific/technical field required; advanced degree preferred
    
    
    
    • 
      
    • A minimum 3 years of relevant work experience.
      
    • Part Manufacturing and Product Engineering experience
      
    • 3D CAD and ability to create detailed part drawings using Geometric Dimensioning & Tolerancing.
      
    • Strong project management experience
      
    • Ability to lead, motivate, influence, and supervise cross-functional teams
      
    • Composition, execution, and analysis for development and characterization protocols
      
    • Experience in Design of Experimentation (DOE) and problem-solving methodologies
      
    • Technical understanding of manufacturing equipment, processes, and product design
      
    • Excellent communication, interpersonal and organizational skills
      
    • Understanding of GMP/ISO regulations or validation practices in a regulated environment
      
    • Experience working across functions to deliver complex projects
      
    • Preferred:
      
    • Advanced technical training in statistics or Process Excellence certification
      
    • Design Analysis Software (e.g., Finite Elemental Analysis)
      
    • Initab Experience
      
    • Experience with automation technologies
      
      

Keywords: Katalyst Healthcares & Life Sciences, Boston , Manufacturing Quality Engineer, Engineering , Andover, Massachusetts