Sr. Principal Software Systems Engineer - Relocation Assistance

$144k - $198k

Baxter

Baxter seeks a Senior Principal Software Systems Engineer to lead R&D efforts on infusion pump platforms and connected digital applications. The role involves driving software development best practices, providing technical leadership to distributed teams, and ensuring compliance with medical device regulatory standards.

Responsibilities

Implement and champion software systems development best practices using Agile PDLC/SDLC and Systems Engineering methodologies
Provide technical leadership, mentorship, and guidance to distributed R&D teams on innovation and excellence
Develop system and software architectures for digital applications while ensuring regulatory compliance with ISO 13485 and IEC 62304
Lead ISO 14971 risk analysis activities and manage product complaints with impact assessments
Define test strategies and collaborate with verification engineers on system validation plans

Requirements

Bachelor's degree in engineering with 10+ years experience, or Master's degree with 8+ years experience
Proven experience with regulated medical device or biotechnology products and connected systems
Expertise in requirements management, risk management, and Agile development methodologies
Strong oral and written communication skills and regulated industry documentation experience
Cloud-based digital applications experience (AWS, Azure, or similar) preferred
Medical device cybersecurity design knowledge preferred
Familiarity with electro-mechanical devices preferred

Apply

Vacancy posted 1 day ago

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