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R&D Engineer Sr.

Little Canada, MN 55117

Posted: 02/01/2023 Employment Type: Contract Job Category: Engineering Job Number: 541054 Is job remote?: No Country: United States

Job Description

Target PR: $40-50 commensurate with experience

Product line support for design and development of Electrophysiology Medical Systems for Navigation, Mapping, Recording and Ablation. System engineering duties include:
  • Communicate and execute on-time completion of systems engineering deliverables
  • Write operational concept documents to describe changes and integrate information into system architecture specification documentation
  • Follow systems engineering processes to integrate system, software and hardware changes from development to production.
  • Development and analysis of system use cases and requirements.
  • Work with cross functional teams to understand and meet regulatory standard updates (e.g. EUMDR, 60601)
  • Document issues, own and solve issues delegated to Systems Engineering.
  • Ability to work independently with minimal supervision.
  • Maintain high standards for content completion, integrity, and regulatory & standards compliance.
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Perform other duties and responsibilities as assigned by functional management based on the current project/business objectives and regular predictable attendance.
  • 2 years’ experience in medical device development
  • Bachelor’s Degree in Systems, Electrical, Mechanical, Software or Biomedical Engineering.
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