Senior Principal Medical Systems Architect

Baxter International Inc.; Milwaukee (WI); Hybrid; USD 128,000 - 176,000; Full time

Benefits offered by this job

Annual incentive bonus

Medical and dental coverage from day 1

401(k) plan with company match

Job summary

Baxter International Inc. is seeking a Sr. Principal Systems Engineer to drive the technical roadmap for medical device product families.

You will lead cross-functional teams across engineering, clinical, and marketing to translate market needs into robust system requirements and architecture. The role emphasizes risk management, design history files, and regulatory compliance, with collaboration across R&D and manufacturing.

Qualifications

• Bachelor’s degree in a technical field and 8+ years of experience in medical devices.
• Knowledge of ISO 14971 and IEC 60601 is preferred.
• Experience applying systems engineering in an Agile SAFe setup.

Responsibilities

• Manage and own the technical roadmap for product families; align with Upstream Marketing.
• Collaborate with Program Management, Marketing, and Customers to translate market needs into requirements.
• Lead design inputs and digital interface requirements development.
• Develop user and clinical workflows to drive requirement analysis.
• Own system architecture and lead multi-disciplinary resources.
• Coordinate and resolve interface issues across engineering, manufacturing, regulatory, and marketing.
• Define test strategies with verification engineers for validation plans.
• Oversee DHF documentation and IEC usability requirements.
• Lead risk management activities per IEC 14971.
• Support CAPA, post-market investigations and cross-functional product support.

Skills

Technical leadership

Systems engineering

Medical device knowledge

Agile SAFe

MATLAB

Azure DevOps

Cross-functional teamwork

Decision making

Education

Bachelor’s Degree in Mechanical, Electrical, Software, Biomedical Engineering or comparable technical subject area

Tools

Polarion

Trackwise

Job description

Baxter International Inc. is seeking a Sr. Principal Systems Engineer to drive the technical roadmap for medical device product families.

You will lead cross-functional teams across engineering, clinical, and marketing to translate market needs into robust system requirements and architecture. The role emphasizes risk management, design history files, and regulatory compliance, with collaboration across R&D and manufacturing.