Sr. Systems Engineer Risk Management (Medical Devices)

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.