Senior Software Systems Engineer, Regulated Med Devices

Zvh; Raleigh (NC); On-site; USD 104,000 - 143,000; Full time

Benefits offered by this job

Medical and dental coverage

401(k) with ESPP

Paid holidays and PTO 20–35 days

Job summary

Baxter is seeking a Senior Software Systems Engineer to join our R&D/Software group and help develop groundbreaking healthcare solutions for infusion pump platforms and connectedDigital Applications. You will drive best practices, utilize AI techniques, and lead a distributed team while ensuring regulatory compliance and high quality.

Responsibilities include defining system requirements, architecture, risk analysis, and verification/validation planning in a regulated environment.

Qualifications

• Bachelor’s degree in engineering with 3+ years of experience.
• Experience with regulated medical devices/biotechnology.
• Experience with cloud-based digital applications (AWS/Azure).
• Experience applying AI/ML in digital applications is a plus.
• Strong documentation skills and regulatory compliance knowledge.

Responsibilities

• Drive best practices in software systems development and product lifecycles using Agile PDLC/SDLC and Systems Engineering.
• Lead AI-driven prototyping and implement rapid requirements while ensuring quality.
• Provide technical leadership to a distributed R&D team.
• Develop innovative solutions for complex software system challenges, meeting deadlines.
• Contribute to robust system architectures for digital applications with regulatory alignment.
• Translate user needs into system requirements and lead cross-functional integration.
• Write and own design inputs/requirements ensuring ISO 13485 and IEC 62304 compliance.
• Lead ISO 14971-based risk analysis and mitigation activities.
• Define test strategies for system/software verification and validation.
• Conduct ad-hoc testing to ensure product quality.
• Enforce Agile/Scrum planning and timely delivery.
• Collaborate with stakeholders to improve processes and mentorship.
• Interface with design transfer to manufacturing and service teams.
• Address product issues with impact assessments on requirements and risks.
• Ensure compliance with product development processes and quality systems.

Skills

Regulated product development

Cloud-based apps

AI/ML in digital apps

Requirements management

Risk management

Agile/Scrum

Communication skills

Documentation in regulated industry

Education

Bachelor’s degree in engineering

Tools

AWS/Azure

Job description

Baxter is seeking a Senior Software Systems Engineer to join our R&D/Software group and help develop groundbreaking healthcare solutions for infusion pump platforms and connectedDigital Applications. You will drive best practices, utilize AI techniques, and lead a distributed team while ensuring regulatory compliance and high quality.

Responsibilities include defining system requirements, architecture, risk analysis, and verification/validation planning in a regulated environment.