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Senior niche medical device systems role with regulatory and MBSE requirements reduces applicant competition.
Requires domain-specific medical device, DICOM/HL7 and regulatory experience, limiting cross-industry transferability.
Explicit 10–15 years plus mandatory IEC 62304/ISO 13485/FDA and MBSE requirements make filters very strict.
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Define and own the end-to-end system-level architecture for integrated sensing, AI, data analytics, and cloud connectivity in image-guided therapy solutions.
Translate clinical and business requirements into scalable, standards-compliant hardware and software designs, ensuring regulatory adherence and real-time clinical workflow automation.
Lead architecture review boards, manage subsystem interfaces, support verification planning, and mentor engineers in systems thinking and architecture best practices.
Bachelor's or Master's degree (or PhD) in Systems Engineering, Electronics, Computer Science, Biomedical Engineering, or related field.
10–15 years experience in systems engineering for complex hardware/software products; medical device or health-tech experience strongly preferred.
Proven expertise in system architecture definition, requirements engineering (SysML, UML), and interface management.
Experience with medical device standards and regulatory frameworks (IEC 62304, ISO 13485, FDA 21 CFR Part 820).
Experienced in defining and managing system architectures that integrate hardware, software, AI, and cloud components in regulated medical environments.
Skilled in collaborating across cross-functional teams and engaging clinical stakeholders to validate design against real-world workflows.
Familiarity with sensing technologies, camera/imaging systems, healthcare interoperability standards (DICOM, HL7), and cloud microservices architecture.