Engineer III

Manpower Engineering
Roundlake, IL
17 May 2024

Vacancy expired!

Engineer III Location: Round Lake, IL. This position is hybrid (3 days onsite and 2 days remote), so candidates need to be local to the area. Duration: 12 months with the possibility of extension/conversion Responsible for supporting the development of new products and on-market products used in surgical procedures. This person should be able to work in a matrix environment through partnerships with R&D and other cross functional team members. This position is in need of a strong understanding of Quality compliance by building quality into products using design control and risk management principles in compliance with regulatory standards and Baxter procedures.

Essential Duties and 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

    Qualifications:
  • 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

    Education and Experience:
  • 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
  • ID: #49950469
  • State: Illinois Roundlake 60041 Roundlake USA
  • City: Roundlake
  • Salary: $40 - $44.89 per hour
  • Job type: Permanent
  • Showed: 2023-05-17
  • Deadline: 2023-07-15
  • Category: Et cetera