Senior Systems Engineer ? Risk Management

This is a remote position.

Job Title: Senior Systems Engineer ? Risk Management

Location: Remote

Employment Type: 6-month contract with potential for extension

Overview

We are seeking an experienced Systems Engineer to support risk management activities for Front Line Care Patient Monitoring Portfolio. This role requires a strong background in formal systems engineering practices and risk management within a regulated environment. The ideal candidate will act as a subject matter expert, collaborating with cross-functional teams to ensure compliance with ISO 14971 and design control and risk management policies.

Key Responsibilities

• Provide expert guidance to functional owners on planning and updating elements of the risk management file.
  
• Support end-to-end processes:
  
• Identify stakeholder needs
  
• Translate needs into design inputs
  
• Trace design inputs to design outputs
  
• Analyze hazardous situations using operational, functional, and physical architectures.
  
• Drive systems engineering processes to achieve ISO 14971 compliance.
  
• Communicate effectively with diverse stakeholders, including Quality, Systems/Risk, Project Management, Regulatory Affairs, and Marketing.
  
• Ensure all work aligns with policies and procedures for design control and risk management.
  

Experience:

• 10+ years in a formal systems engineering environment.
  
• Medical device experience, particularly with Quality Management Systems (preferred).
  
• Certifications: INCOSE Certified (preferred).
  

• Software development experience (plus).
  
• Software/Electrical Engineering development experience (plus).
  
• Strong understanding of risk management principles and ISO 14971 compliance.
  
• Proven ability to work collaboratively and communicate across multiple functions.
  

• Ability to manage complex systems and risk management processes.
  
• Strong analytical and problem-solving skills.
  
• Familiarity with regulated environments and design control processes.
  

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