Senior Software Architect

Job Description

Senior Software Architect – Medical Device R&D

Department : Research & Development – Software Engineering

We are seeking a Senior Software Architect with direct, hands-on experience developing software for regulated medical devices . This role is part of the R&D engineering team and focuses on bringing innovative medical technologies from concept through design and verification - all in alignment with FDA QSR, EU MDR , and international safety standards .

Applications without direct experience in regulated medical device software will not be considered.

Responsibilities

• Define, document, and maintain software architecture and system-level design in compliance with FDA QSR , EU MDR , and IEC 62304 .
• Collaborate with cross-functional R&D teams - including hardware, systems, quality, and regulatory - to ensure safe, effective, and compliant software solutions.
• Lead architectural decision-making, ensuring traceability between requirements, design, implementation, and verification .
• Establish and maintain software design controls , including risk management per ISO 14971 and usability engineering under IEC 62366 .
• Provide technical leadership in software lifecycle planning, configuration management, and interface definition.
• Review and approve design documentation, risk analyses, and verification plans to ensure architectural consistency and compliance.
• Mentor software engineers and contribute to continuous improvement of R&D processes and toolchains.
• Support cybersecurity, data privacy , and interoperability considerations in line with AAMI TIR57 and IEC 81001-5-1.

Qualifications

#SaMD #MedTech #DigitalHealth #MedicalDevices #SystemsEngineering #IEC62304

#HealthTech