Jobs at HistoSonics

Supports commercial and clinical medical device launches by troubleshooting complex technical issues remotely and onsite, assisting procedures, developing troubleshooting and training materials, coordinating cross-functional engineering support, maintaining design documentation, prioritizing product issues, and supporting customer demos, conferences, and field activities. Requires extensive domestic travel, including overnight stays and some weekends.

Lead product assurance for commercial production: inspection strategy, supplier evaluation, in-process and final testing, PFMEA, product release/DHR review, nonconforming material and complaint analysis, process validation, CAPA investigations, and quality system document control to ensure compliance with medical device regulations.

Supports commercial, clinical, and pre-clinical medical device procedures and product launches in the field. Troubleshoots customer issues, develops resolution plans and troubleshooting guides, supports cases, demos, conferences, and customer engagements, and creates training materials for future product support engineers. Collaborates with Operations, R&D, Education, Sales, Clinical Affairs, and leadership while maintaining design-control documentation and project deliverables.

Leads learning and development strategy for physician and internal clinical education across medical device indications and technology platforms. Designs scalable curricula, blended learning pathways, assessments, competency frameworks, and educational content. Partners with clinical experts, physician faculty, Medical Affairs, Regulatory, Marketing, and Commercial teams to ensure accurate, compliant, evidence-based programs. Oversees content governance, lifecycle management, vendors, and learning technologies while evaluating program effectiveness through learner and business performance metrics.

Designs and maintains automated test frameworks and tooling for medical-device software. Develops unit, API, integration, UI, and system tests; performs exploratory, regression, and verification testing; manages test environments and defects; investigates root causes; integrates testing into CI/CD; and maintains requirements traceability and compliance with quality and regulatory standards including IEC 62304 and ISO 14971.

Provides clinical expertise during medical device implementations, physician onboarding, live procedures, site launches, and technology integrations. Supports procedural excellence, clinical and safety protocol adherence, workflow optimization, and sustainable utilization growth. Partners with Account Managers, physicians, clinical staff, Commercial, Clinical, and R&D teams to drive adoption and resolve real-time challenges. The role is field-based, requiring extensive domestic travel and overnight stays within an assigned sales territory.

Leads software architecture, development, regulatory compliance, risk management, verification, and validation for new medical-device indications. Owns IEC 62304 documentation, software development plans, requirements, architecture, DFMEA, traceability, testing, and release qualification. Partners with Regulatory Affairs, Quality, Clinical, Systems Engineering, and Product teams to support programs from first-in-human studies through commercialization. Manages technical milestones, vendors, risks, and cross-functional deliverables while mentoring engineers and shaping technology strategy.

Deliver physician education for the Edison Histotripsy System through didactic, hands-on, ultrasound, simulation, case-based, and observational training. Teach system operation, imaging, anatomy, treatment planning, and procedural workflows; coach physicians; troubleshoot technology and training challenges; facilitate workshops and simulation labs; maintain expert product knowledge; and partner with faculty and cross-functional teams to ensure consistent, clinically credible education.

Delivers hands-on clinical and technical education to physicians using the Edison Histotripsy System. Teaches ultrasound, imaging, anatomy, treatment planning, procedural workflows, system operation, and troubleshooting through didactic, simulation, case-based, and observational training. Adapts instruction to learner needs, coaches physicians, supports trainer standardization, and partners with medical, clinical, sales, R&D, and physician faculty teams. The role is remote in Southern California and requires up to 70% travel with overnight stays.

Supports clinical implementation, physician onboarding, site launches, and live procedures for the HistoSonics Edison System. Provides procedural expertise, ensures clinical and safety standards, optimizes workflows, and drives adoption and utilization at customer sites. Partners with Account Managers, Clinical, Commercial, and R&D teams to develop account plans, resolve challenges, and promote sustainable procedural growth. This remote field role covers North Carolina and requires up to 75% travel, frequent overnight stays, a valid driver’s license, and personal vehicle use.

Supports clinical implementation, physician onboarding, live procedures, and site launches for HistoSonics histotripsy technology. Provides procedural expertise, ensures clinical and safety compliance, optimizes workflows, and partners with Account Managers to drive utilization and sustainable account growth. Builds relationships with physicians and clinical staff, shares clinical insights with R&D and commercial teams, and provides frequent on-site support across a field territory.

Provides clinical expertise for HistoSonics technology implementation, physician onboarding, site launches, and live procedures. Supports procedural excellence, clinical and safety compliance, workflow integration, and physician relationships. Partners with Account Managers and cross-functional teams to drive adoption, utilization, account growth, and ongoing optimization. The field-based role requires extensive domestic travel, overnight stays, hospital credentialing, and procedural support within a sales territory.

Supports clinical implementation and adoption of the HistoSonics Edison System across UK healthcare sites. Provides physician onboarding, live procedural and imaging support, site-launch coordination, workflow optimization, and clinical protocol guidance. Partners with commercial, clinical, R&D, and global leadership teams to expand utilization and sustain account growth. Maintains relationships with physicians and clinical staff while addressing real-time procedural challenges and meeting hospital credentialing and compliance requirements.

Field-based Account Manager responsible for driving adoption, utilization, and post-sale program execution for the HistoSonics Edison Platform. Manage stakeholder relationships, lead clinical/technical demonstrations and training, develop strategic programs and KOL sites, coordinate pilot launches, track KPIs, and achieve territory revenue targets while collaborating with cross-functional teams.

Supports clinical trial, real-world evidence, and observational study analyses for medical devices. Develops, validates, and executes SAS or R programs for analysis datasets, tables, listings, and figures; contributes to statistical analysis plans; troubleshoots data and programming issues; incorporates outputs into clinical study reports; ensures CDISC compliance, traceability, and reproducibility; and leads quality control and review of other programmers’ work.

Leads human factors strategy and execution for medical device development across pre-market and post-market activities. Responsibilities include user and workflow research, use-related risk assessments, interface design support, formative and summative usability studies, regulatory documentation, submission support, post-market usability improvements, process optimization, and mentoring human factors engineers.

Leads cloud platform engineering, agentic AI automation, and Windows/Linux systems imaging across the CTO organization. Manages and develops technical teams, sets infrastructure strategy, governs Azure platforms and IaC, and drives secure, compliant engineering practices. Oversees AI governance, endpoint security, validated computing environments, regulatory compliance, architecture reviews, and resolution of critical infrastructure incidents. Partners cross-functionally with engineering, security, quality, regulatory, and information systems leaders in a regulated medical device environment.

Leads planning, coordination, execution, and release readiness for regulated medical-device software. The role aligns engineering, quality, regulatory, product, and systems teams; manages milestones, dependencies, risks, Agile ceremonies, release documentation, DHF deliverables, dashboards, and audit readiness across the software development lifecycle.

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 information security governance, risk, and compliance: own ISMS and policy portfolio, map ISO 27001 to NIST CSF, run security maturity assessments, manage third-party risk, administer security awareness and phishing programs, partner with Legal on privacy (HIPAA/GDPR), coordinate audits/certifications, and mentor GRC staff while setting standards and remediation roadmaps.