Job Title : Enterprise Architect – Medical Device Software & Digital Engineering
Location : Germany (Remote / Hybrid options available) - Nearshore
Fluent in English; German language proficiency should be minimum of C1 level
Role Overview
We are seeking a visionary and technically adept Enterprise Architect with deep expertise in Medical Device Software Development , SDLC management , Service-Oriented Architecture (SOA) , and Enterprise Application Integration (EAI) . This role is pivotal in driving our digital transformation initiatives across global platforms, with a focus on mobile application development , digital engineering , and compliance within regulated medical environments .
Key Responsibilities
- Lead enterprise architecture strategy across medical device software platforms and digital health solutions
- Oversee full Software Development Life Cycle (SDLC) for embedded and cloud-connected medical devices
- Architect and integrate complex systems using SOA , microservices , and enterprise integration patterns
- Collaborate with cross-functional teams including R&D, Regulatory, and Product Management to ensure alignment with medical device standards (e.g., IEC 62304, ISO 13485)
- Design scalable mobile applications and digital tools for patient engagement, clinical workflows, and remote monitoring
- Evaluate and select technologies that support long-term business and technical goals
- Ensure interoperability between legacy systems and modern platforms through robust integration strategies
- Act as a technical liaison with external medical device manufacturers and partners
- Maintain architectural governance and ensure compliance with data privacy and cybersecurity regulations (e.g., GDPR, MDR)
Required Qualifications
Bachelor’s or Master’s degree in Computer Science, Biomedical Engineering, or related field7+ years of experience in enterprise architecture, with a strong focus on medical device software developmentProven track record in SDLC management within regulated environmentsDeep understanding of SOA , EAI , and modern integration frameworks (e.g., HL7, FHIR, RESTful APIs)Experience working directly with medical device manufacturers and navigating compliance landscapesStrong background in digital engineering , mobile app development , and cloud-native architectures