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

Job Description:


  • 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


    • 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

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