Engineer

Company: Katalyst Healthcares & Life Sciences
Location: Round Lake
Posted on: May 27, 2023

Job Description:

Responsibilities:

• 
  
• Applies state of the art techniques in the area of expertise to support the development of new or improved products
  
• Supports the sustainability and life cycle management of existing products
  
• Ensures compliance with global quality systems and Regulatory requirements related to product and process
  
• Provides Quality Assurance support and guidance for verification and validation of product requirements
  
• Performs design change control activities including impact assessments, reviews, and approvals
  
• Takes lead role in CAPA activities such as investigation, implementation, or verification of effectiveness
  
• Supports risk management activities as they relate to product and post market surveillance
  
• Interacts with on-shore and off-shore suppliers to complete project related activities
  
• Applies a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise toward the development of new or enhanced products
  
• Plans, executes, and works with minimal supervision and independent judgment
  
  
  Responsibilities:
  
  
  • 
    
  • Must have experience working with all classes of Medical devices preferably implantables, Biologics, and/or combination products with advanced training and demonstrate proficiency in problem solving, total quality management, DHF remediation, Risk file remediation, EUMDR, problem analysis and resolution, and design of experiments
    
  • Experience with New product development activities as R&D lead or QE lead in various product development teams
    
  • Demonstrates leadership skills to handle sustaining product support activities involving Complaint investigations, Trigger evaluations and Change controls
    
  • Extensive cross-functional team experience, including technical and non-technical work
    
  • Strong interpersonal, communication, influencing, and negotiation skills
    
  • B.S. degree in Engineering with at least 1-3 years of experience working in a regulated environment
    
  • Higher degrees desired with relevant experience in medical device industry
    
  • Demonstrated success in delivering results on several technical challenges
    
  • Working knowledge of medical device international standards
    
    
    

Keywords: Katalyst Healthcares & Life Sciences, Arlington Heights , Engineer, Engineering , Round Lake, Illinois