Sr. Systems Engineer Risk Management (Medical Devices)

Overview

On Site
Accepts corp to corp applications
Contract - W2
Contract - to 31/05/2026

Skills

Performance Management
Preventive Maintenance
Regulatory Compliance
Project Management
Regulatory Affairs
Marketing
Policies and Procedures
Continuous Improvement
Medical Devices
Quality Management
Software Development
Electrical Engineering
ISO 9000
Risk Management
Design Controls
Analytical Skill
Communication
Management
Systems Engineering

Job Details

Job Title: Systems Engineer Risk Management Support

Location: Remote (CST hours 7 AM 6 PM, flexible)
Duration: Contract (possibility of extension)

Overview:

Seeking an experienced Systems Engineer to support risk management activities for the Front Line Care Patient Monitoring Portfolio. The ideal candidate will act as a Subject Matter Expert (SME) in risk management, working closely with cross-functional teams to ensure compliance with ISO 14971 and Baxter's quality management system.

Key Responsibilities:

  • Support and guide risk management activities for patient monitoring products.

  • Partner with functional owners to plan, update, and maintain risk management files.

  • Communicate effectively with stakeholders including Quality, Systems/Risk, Project Management, Regulatory Affairs, and Marketing.

  • Translate stakeholder needs into design inputs and trace these through to design outputs.

  • Utilize operational, functional, and physical architectures to analyze potential hazardous situations.

  • Ensure all risk management work aligns with Baxter's design control and risk management policies and procedures.

  • Contribute to continuous improvement of systems engineering and risk management practices.

Qualifications & Experience:

  • Master's degree in Systems Engineering (required).

  • INCOSE Certification preferred.

  • 10+ years of professional experience in systems engineering or related roles.

  • Experience in a formal systems engineering environment is required.

  • Medical device industry experience with Quality Management Systems highly preferred.

  • Software development and/or Electrical Engineering background a strong plus.

  • Proven ability to work collaboratively across multidisciplinary teams.

Preferred Skills:

  • Deep understanding of ISO 14971 risk management standards.

  • Familiarity with FDA design control requirements (21 CFR Part 820).

  • Strong analytical, organizational, and communication skills.

  • Experience managing end-to-end systems engineering processes from stakeholder needs to design outputs.

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