Jobs at HistoSonics

Lead end-to-end third-party integration for a medical device software platform: prototype, design, implement and document interfaces to vendor hardware/SDKs/APIs; define data contracts and compatibility requirements; perform code reviews; drive integration architecture decisions; ensure Quality Management System and regulatory (FDA/ISO) compliance; mentor junior engineers and support broader software development and customer issue investigations.

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.

Lead and manage a team of software test engineers to plan, execute, and report manual and automated testing for medical device software. Participate in design reviews, risk assessments, test environment setup, defect tracking, regression scope analysis, and track QA metrics to ensure compliance with medical device quality systems.

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.

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.

Lead planning, coordination, execution, and release of medical device software projects for the Edison system. Manage end-to-end software lifecycle across device, connectivity, and cloud components; ensure regulatory compliance (IEC 62304, FDA guidance), cross-functional alignment, release readiness, risk escalation, and schedule/resource management. Serve as central contact, drive sponsor decisions, and facilitate Agile teams using tools like Jira or Azure DevOps. Travel up to 10%.

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 staff, leads demonstrations and installations, manages stakeholder relationships, tracks KPIs, and collaborates cross-functionally to meet territory revenue targets and expand clinical use.

Lead upstream clinical program activities for new device indications (focus neurology). Design pre-market feasibility and pivotal studies with R&D, Regulatory, and Marketing; define CRF and data strategy; support regulatory submissions, audits, procedure development, and physician collaborations to generate evidence for regulatory and commercial needs.

Develop and optimize ultrasound transducers and production procedures, convert prototypes into manufacturable products, perform electrical/mechanical fabrication and benchtop testing, document builds, troubleshoot failures, and collaborate with research, manufacturing, and suppliers while following quality system and design controls.

Lead planning, coordination, and execution of medical device software projects from concept through commercialization. Manage cross-functional teams, track progress, oversee configuration management, ensure regulatory compliance (IEC62304, FDA guidance, HIPAA, GDPR), produce documentation, and communicate status while addressing risks and dependencies. Hands-on with software development and firmware integration.

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.

Develop, test, document, and integrate software enabling planning and delivery of histotripsy treatment. Build prototypes, expand automated test capabilities, author design specifications, collaborate with research, product, and test teams, and ensure compliance with the Quality Management System.

Lead clinical ultrasound efforts to optimize workflows, train and mentor clinical education teams, support clinical trials and R&D, implement continuous improvement, and drive procedural standardization and adoption across indications for a novel histotripsy medical device.

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.

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 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.

Field-based Account Manager responsible for driving adoption, utilization, and commercial success of the HistoSonics Edison platform. Duties include program development and launches, clinical and technical demonstrations, post-sale installation and adoption, stakeholder and KOL engagement, cross-functional collaboration, market analysis, and meeting territory revenue targets while supporting training and regulatory compliance.