Skills Alliance
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 Bachelors or Masters degree
in Software Engineering, Computer Science, Electrical Engineering, or a related technical discipline. 8+ years
of software development experience, with at least
4 years in medical device software architecture or design . Deep understanding of
IEC 62304 ,
ISO 13485 ,
ISO 14971 , and
FDA design controls . Proven track record architecting
embedded ,
connected , or
cloud-integrated medical systems . Strong background in
C++, C#, or Python ; experience with software frameworks and toolchains for regulated environments. Excellent analytical, documentation, and communication skills - able to bridge software, hardware, and regulatory perspectives.
#SaMD #MedTech #DigitalHealth #MedicalDevices #SystemsEngineering #IEC62304 #HealthTech
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 Bachelors or Masters degree
in Software Engineering, Computer Science, Electrical Engineering, or a related technical discipline. 8+ years
of software development experience, with at least
4 years in medical device software architecture or design . Deep understanding of
IEC 62304 ,
ISO 13485 ,
ISO 14971 , and
FDA design controls . Proven track record architecting
embedded ,
connected , or
cloud-integrated medical systems . Strong background in
C++, C#, or Python ; experience with software frameworks and toolchains for regulated environments. Excellent analytical, documentation, and communication skills - able to bridge software, hardware, and regulatory perspectives.
#SaMD #MedTech #DigitalHealth #MedicalDevices #SystemsEngineering #IEC62304 #HealthTech