Senior Principal MedTech Software Systems Architect

Zvh; Raleigh (NC); On-site; USD 144,000 - 198,000; Full time

Benefits offered by this job

Health and dental insurance

401(k) with company match

Employee stock purchase plan (ESPP)

Job summary

Baxter is seeking a Senior Principal Software Systems Engineer to lead design and development for Infusion Pump Platforms and connected digital applications. You will shape system architectures, guide cross-functional teams, and ensure compliance with ISO 13485, IEC 62304, and ISO 14971 while delivering high-quality healthcare software solutions.

The role emphasizes agile execution, risk management, and collaboration with manufacturing and service teams, with a flexible onsite policy and a base

Qualifications

• Bachelor's degree in engineering with 10+ years or Master's with 8+ years experience.
• Regulated products and connected systems experience in medical devices/biotech.
• Experience with cloud-based digital applications (AWS/Azure) preferred.
• AI/ML paradigms in Digital Applications experience a plus.
• Familiarity with electro-mechanical devices preferred.
• Expertise in requirements management, risk management, and Agile development with backlog care.
• Knowledge of medical device cybersecurity design paradigms is a plus.
• Excellent oral and written communication; strong documentation in regulated industry.

Responsibilities

• Lead software system design and architecture in R&D software group.
• Mentor distributed cross-functional teams and enforce best practices.
• Develop and verify system requirements and risk mitigation strategies.
• Collaborate with verification to define test strategies and validation plans.
• Translate user needs into functional and non-functional requirements.
• Ensure compliance with QMS, ISO 13485, IEC 62304, and ISO 14971.

Skills

Technical leadership

Systems engineering

Agile methodologies

Requirements management

Risk analysis

AI/ML in digital apps

Cloud-based applications

Cybersecurity design

Communication

Education

Bachelor's degree in engineering

Master's degree

Tools

AWS

Azure

Job description

Baxter is seeking a Senior Principal Software Systems Engineer to lead design and development for Infusion Pump Platforms and connected digital applications. You will shape system architectures, guide cross-functional teams, and ensure compliance with ISO 13485, IEC 62304, and ISO 14971 while delivering high-quality healthcare software solutions.

The role emphasizes agile execution, risk management, and collaboration with manufacturing and service teams, with a flexible onsite policy and a base