Senior Software Systems Architect – Medical Devices

Baxter Healthcare; Raleigh, Northern (NC, KY); Hybride; USD 144 000 - 198 000; Plein temps

Avantages offerts par ce poste

Medical and dental coverage

401(k) with company matching

Employee stock purchase plan (ESPP)

Résumé du poste

Join Baxter as a Senior Principal Software Systems Engineer in the R&D/Software organization, leading digital applications for Infusion Pump Platforms and connected ecosystems, advancing medical device software in a regulated setting.

You will guide agile teams, shape architectures, translate user needs into system requirements, drive risk analysis and verification, and ensure ISO 13485 and IEC 62304 compliance while fostering collaboration across functions.

Qualifications

• Bachelor’s degree in engineering with 10+ years or Master’s with 8+ years.
• Experience with regulated products and connected medical devices.
• Experience with cloud-based digital applications (AWS/Azure).
• Familiarity with electro-mechanical devices.
• Expertise in requirements and risk management in Agile environments.
• Knowledge of cybersecurity paradigms for medical devices.
• Exceptional oral and written communication.
• Strong documentation skills in a regulated industry.

Responsabilités

• Drive best practices in software systems development using Agile PDLC/SDLC and Systems Engineering.
• Provide technical leadership to a distributed R&D team.
• Develop innovative solutions to complex software system challenges.
• Assist in establishing robust architectures for digital applications.
• Translate user needs into functional system requirements and lead cross-functional teams.
• Write and own design inputs/requirements ensuring QMS and regulatory compliance.
• Lead ISO 14971-based risk analysis activities.
• Define test strategies with verification and validation plans.
• Conduct ad-hoc testing to ensure product quality.
• Enforce Agile/Scrum planning and tracking.
• Collaborate with stakeholders to mentor and improve processes.
• Interface with design transfer with manufacturing, service, and training staff.
• Address product complaints with impact assessments on requirements and risks.
• Uphold compliance with product development processes and quality systems.

Connaissances

Regulated products experience

Cloud-based applications

Agile / Scrum

Requirements management

Risk management

Medical device cybersecurity

Communication skills

Documentation skills

Electro-mechanical familiarity

Formation

Bachelor’s degree in engineering

Master’s degree in engineering

Description du poste

Join Baxter as a Senior Principal Software Systems Engineer in the R&D/Software organization, leading digital applications for Infusion Pump Platforms and connected ecosystems, advancing medical device software in a regulated setting.

You will guide agile teams, shape architectures, translate user needs into system requirements, drive risk analysis and verification, and ensure ISO 13485 and IEC 62304 compliance while fostering collaboration across functions.