Jobs at HistoSonics

Coordinate planning and execution of software releases for the Edison system, align cross-functional teams, drive day-to-day delivery, manage Agile ceremonies and release readiness, maintain dashboards and DHF documentation, ensure regulatory compliance (IEC 62304) and audit readiness, and communicate status to stakeholders.

Field-based Clinical Specialist providing procedural and implementation support for the Edison System. Lead site launches, support live procedures, partner with account managers to drive clinical adoption, optimize workflows, ensure compliance, and liaise with Clinical, Commercial, and R&D teams to sustain procedural growth.

Lead mechanical engineering efforts to convert lab prototypes into scalable medical devices. Design and test ultrasound/transducer and system components, support preclinical and clinical research, develop test procedures and design documentation, analyze in vivo/ex vivo data, contribute to regulatory submissions and IP, and ensure compliance with quality management and design control systems.

Design and document mechanical components and assemblies for regulated medical devices using SolidWorks. Create CAD models, drawings, BOMs, and verification/validation documentation, support prototyping (3D printing, CNC), collaborate with cross-functional teams, manage PDM/CAD data, and participate in risk analysis and design reviews to transition prototypes into manufacturable production designs.

Designs, analyzes, and interprets clinical trial, RWE, and observational data for a medical device. Develops statistical plans, predictive models, and ensures data quality, regulatory compliance, and traceability. Collaborates with clinical, regulatory, and data teams, supports submissions and publications, mentors interns, and represents the company externally.

Lead full-cycle talent acquisition for a high-growth medical device company: design hiring strategy, optimize ATS and processes, build interview frameworks, drive employer branding, expand hiring globally, manage stakeholder relationships, and run talent programs (onboarding, pipelines, internships).

Field-based account manager responsible for driving adoption, utilization, and post-sale program management of the HistoSonics Edison Platform. Develops and launches clinical programs, trains and supports clinicians, builds KOL relationships, executes territory business plans, and meets sales revenue targets while collaborating cross-functionally.

Lead design assurance activities for medical device product development with emphasis on IEC 62304 software design assurance. Define design requirements, V&V strategies, risk management, usability evaluation, design reviews, and regulatory compliance. Support design transfer, supplier inspection strategies, audits, and continuous improvement of the Quality Management System across hardware, software, and system-level products.

Drive adoption, utilization, and revenue for the HistoSonics Edison Platform within an assigned territory by developing and launching clinical programs, leading post-sale installations and clinical/technical demonstrations, managing stakeholder relationships and KOLs, tracking KPIs, and collaborating cross-functionally to support customer training, reimbursement, and product feedback.

Lead systems engineering for histotripsy-based medical device development: convert prototypes into scalable products; design, test, and document acoustic, electrical, robotic, and software subcomponents; plan and run preclinical/clinical experiments; support verification/validation, regulatory submissions, statistical analysis, IP, and quality management; collaborate cross-functionally.

Lead software regulatory compliance and engineering for new medical indications: author IEC 62304 artifacts, manage ISO 14971 risk, oversee verification/validation and testing, drive software project plans, manage vendors, and build/mentor a Neuro software team while defining technology stacks and ensuring DHF-compliant documentation for submissions.

Manage end-to-end program operations for R&D feature-definition and de-risking activities. Maintain master schedules, track risks and resources, coordinate cross-functional and external partner work, support clinical/preclinical logistics, ensure design control compliance, and prepare portfolio-level reporting to enable clean handoffs to system integration teams.

Lead R&D efforts to convert histotripsy prototypes into scalable medical devices by translating clinical needs into engineering requirements, running and documenting experiments (acoustic, electrical, robotic, software), modeling biobehavioral systems, developing preclinical/clinical models, supporting verification/validation and regulatory submissions, managing design control and QMS activities, and contributing to IP and risk analyses.

Provide in-person and remote clinical support for implementation and adoption of the Edison System. Support live procedures, site launches, physician onboarding, workflow optimization, and cross-functional collaboration to drive procedural utilization and clinical excellence.

Provide clinical implementation and live procedural support for the Edison System, partnering with account managers to launch sites, optimize workflows, ensure clinical and safety protocol adherence, and drive procedural adoption across assigned territory. Travel frequently to support physician onboarding, system integration, and ongoing site optimization while collaborating with Clinical, Commercial, and R&D teams.

Provide in-person and remote clinical support for implementation and live procedures using the Edison System. Lead site launches, optimize workflows, partner with account managers, ensure clinical and safety compliance, and drive procedural adoption across assigned territory with up to 75% travel.

Design, build, and maintain minimal, hardened embedded Linux images (ARM64/NVIDIA Jetson) for medical device connectivity. Implement kernel/drivers, security controls (secure boot, TPM, encryption), CI/CD pipelines, automated validation, SBOM and vulnerability management, OTA updates, and regulatory compliance documentation. Collaborate with engineering and regulatory teams for secure deployments in hospital networks.

Provide procedural and clinical support for implementation and adoption of the Edison histotripsy system. Support live cases, site launches, physician onboarding, and workflow optimization. Collaborate with account managers, commercial, clinical, and R&D teams to drive utilization and procedural growth. Maintain clinical excellence, adherence to safety and compliance standards, and strong relationships with clinicians and staff. Travel within the assigned territory up to 75% for on-site support.

Lead product engineering for integration of real-time diagnostic ultrasound into HistoSonics clinical systems. Manage OEM partner feasibility, define system and software requirements, drive prototype development, verification/validation, risk and hazard analyses, and ensure design control documentation for regulatory submissions. Translate clinician feedback into imaging feature requirements and collaborate cross-functionally to advance marketable, compliant ultrasound-guided therapeutic products.

Provide clinical expertise for implementation and live-procedure support of the Edison system, partner with account managers to drive adoption, optimize workflows, and support cross-functional teams to ensure procedural excellence and growth.