R&D Engineer Sr.
Saint Jude Medical Drive Little Canada, MN 55117 US
Job Description
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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