Enterprise Architect – Medical Device Software & Digital Engineering

Role Overview:

We are seeking an accomplished Enterprise Architect with proven expertise in Medical Device Software Development, Digital Engineering, and Enterprise Integration. The ideal candidate will lead architectural strategy and digital transformation initiatives across medical technology ecosystems.

This role involves defining end-to-end architecture for embedded, cloud-connected, and mobile applications that comply with stringent regulatory, cybersecurity, and interoperability standards in global healthcare environments.

Key Responsibilities:

• Lead the enterprise architecture strategy for medical device software platforms and digital health ecosystems.
• Oversee the Software Development Life Cycle (SDLC) for embedded, connected, and cloud-based medical devices.
• Design and implement Service-Oriented Architectures (SOA), microservices, and Enterprise Application Integration (EAI) frameworks.
• Collaborate with R&D, Regulatory, and Product Management teams to ensure compliance with IEC 62304, ISO 13485, MDR standards.
• Architect and scale mobile and cloud-based digital health solutions to enhance patient engagement, clinical workflows, and remote monitoring.
• Evaluate and recommend emerging technologies supporting long-term scalability and digital innovation goals.
• Ensure interoperability between legacy systems and modern digital platforms using integration patterns and middleware strategies.
• Maintain architectural governance aligned with enterprise standards and compliance mandates.
• Partner with medical device manufacturers, cloud providers, and digital health vendors to deliver compliant, integrated solutions.
• Uphold best practices for data privacy, cybersecurity, and regulatory compliance (GDPR, MDR, HIPAA as applicable).

Required Qualifications:

Bachelor’s or Master’s degree in Computer Science, Biomedical Engineering, or related technical discipline.

7+ years of experience in enterprise or solution architecture, ideally within medical device software or regulated life sciences environments.

Strong experience managing SDLC in regulated product development contexts.

Deep expertise in SOA, EAI, and modern integration frameworks (HL7, FHIR, REST APIs, MQ, Kafka).

Proven collaboration with medical device manufacturers and strong understanding of regulatory compliance.

Proficiency in digital engineering, mobile app development, and cloud-native architectures (AWS, Azure, GCP).