Director, Systems Engineering - SaMD
Core
Lead end-to-end integration of a software-enabled capital equipment platform and associated digital technologies for advanced structural heart therapies.
Role type
Director-level technical leader (individual contributor)
Builds
Next-generation software-enabled capital equipment platform and digital technologies for structural heart therapies
Domain
Medical devices / Structural heart disease / Software as a Medical Device (SaMD)
Required skills
Systems architecture and integration, Software as a Medical Device (SaMD), Embedded systems and firmware, Design for Excellence (DFX) principles, Regulated environment design controls, Technical strategy evaluation, Cross-functional influence without authority, Hardware/software/firmware integration, Risk management, Program execution
Preferred skills
Medical device development (Class II/III), Digital health technologies, Cloud-enabled healthcare platforms, Capital equipment platforms, Diagnostic/therapeutic/robotic/imaging systems
Technologies
SaMD, Embedded systems, Firmware, Cloud platforms, Connectivity solutions
Responsibilities
Lead end-to-end integration of software-enabled capital equipment platform, Drive technical execution throughout product lifecycle, Identify and resolve system-level issues and integration risks, Serve as technical leader and systems architecture authority, Ensure alignment with regulatory expectations and cybersecurity requirements, Apply Design for Excellence principles, Lead knowledge-transfer and ownership-transition activities, Partner with OEM suppliers and external development organizations, Influence technical direction across multidisciplinary organizations, Communicate technical recommendations and program health to leadership