Senior Principal Software Systems Engineer: Healthcare Regulatory Tech

Baxter International Inc.; Raleigh (NC); Hybride; USD 144 000 - 198 000; Plein temps

Avantages offerts par ce poste

Medical and dental coverage starting1

401(k) with company match

Employee Stock Purchase Plan (ESPP)

Educational assistance

Paid time off 20+ days and holidays

Résumé du poste

Baxter International Inc. is seeking a Senior Principal Software Systems Engineer to lead development and sustaining activities for Infusion Pump Platforms and connected digital applications.

You will guide best practices across Agile PDLC/SDLC, mentor a dispersed R&D team, and design architectures that ensure interoperability and regulatory compliance. You will translate user needs into robust requirements, drive risk management per ISO 14971, and collaborate with verification and manufacturing

Qualifications

• Bachelor’s degree in engineering with 10+ years of experience or Master’s degree with 8+ years of experience in a related field.
• Experience with regulated medical devices/biotechnology.
• Experience with cloud-based digital applications (AWS/Azure or similar CSPs).
• Experience implementing AI/ML paradigms in Digital Applications is a plus.
• Familiarity with electro-mechanical devices is preferred.
• Expertise in requirements management, risk management, and Agile development.
• Knowledge of medical device cybersecurity design paradigms is a plus.
• Excellent oral and written communication skills.
• Strong documentation in a regulated industry.

Responsabilités

• Drive best practices in software systems development and product lifecycles using Agile PDLC/SDLC and Systems Engineering.
• Provide technical leadership to a distributed R&D team.
• Develop innovative solutions to complex software system challenges.
• Contribute to system and software architectures for digital applications.
• Translate user needs into system requirements and lead cross-functional integration.
• Write and own system/software design inputs to meet QMS and regulatory standards.
• Lead ISO 14971 risk analysis activities and mitigation strategies.
• Define test strategies with verification engineers and perform ad-hoc testing.
• Interface with manufacturing, field service, operations, and customer training.

Connaissances

Agile execution

Systems engineering

Technical leadership

Requirements management

Risk analysis

Communication

Documentation in regulated industry

Formation

Bachelor’s degree in engineering

Master’s degree

Description du poste

Baxter International Inc. is seeking a Senior Principal Software Systems Engineer to lead development and sustaining activities for Infusion Pump Platforms and connected digital applications.

You will guide best practices across Agile PDLC/SDLC, mentor a dispersed R&D team, and design architectures that ensure interoperability and regulatory compliance. You will translate user needs into robust requirements, drive risk management per ISO 14971, and collaborate with verification and manufacturing