Jobs at HistoSonics

Translates stakeholder and business needs into software requirements, specifications, user stories, and use cases for a regulated medical device system. Analyzes system interactions, supports development and QA, validates functionality, traces risks, and collaborates with R&D, quality, manufacturing, field service, and regulatory teams. Requires expertise in hardware-software integration, medical device standards, software development methodologies, and cross-functional communication.

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.

Prospects and qualifies hospitals and health systems for Edison System placements across the Chicago region. Builds relationships with physicians, administrators, and clinical stakeholders; maps target accounts; conducts discovery; maintains pipeline plans; partners with Area Sales Managers on opportunities; coordinates handoffs to Account Managers after sales; identifies KOLs and reference centers; supports conferences and educational activities; and develops clinical and commercial expertise while following regulatory requirements.

The Area Sales Representative builds and qualifies hospital and health-system pipelines for Edison System placements. Responsibilities include account mapping, prospecting physicians and administrators, conducting discovery, maintaining territory plans, partnering with Area Sales Managers on opportunity progression, coordinating post-sale handoffs, identifying KOLs, supporting conferences, and developing clinical and product expertise. The role requires extensive travel and compliance with hospital credentialing and AdvaMed guidelines.

Manages the CONNECT program for a connected medical device, coordinating system DHF deliverables, release schedules, field upgrades, software and hardware dependencies, data privacy, cybersecurity, customer agreements, and Edison System integration. Maintains project governance, risks, resources, documentation, and portfolio visibility while partnering with engineering, quality, regulatory, legal, IT, security, and technical services teams.

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.

The Senior Planner converts forecasts into SAP, manages MRP and purchase plans, and ensures inventory availability for manufacturing. Responsibilities include analyzing inventory levels, shortages, and surpluses; maintaining ERP planning parameters; supporting S&OP, capacity planning, new product introductions, and manufacturing transitions; developing secondary sourcing plans; and coordinating with procurement, engineering, quality, manufacturing, and R&D teams in a regulated medical device environment.

Owns diagnostic ultrasound image quality across histotripsy platforms. Responsibilities include developing and validating B-mode, color Doppler, and power Doppler algorithms; defining quantitative image quality methods; directing ultrasound OEM partners; resolving therapy-related imaging artifacts; supporting design controls, verification, regulatory activities, and clinical programs; and setting the multi-year imaging architecture and roadmap.

Serve as the primary HR partner for a 300+ employee business group, advising Director- and VP-level leaders on workforce planning, organizational design, employee relations, talent and performance management, manager development, succession planning, change management, and HR program implementation. Use workforce analytics to provide insights and recommendations while ensuring policy compliance and supporting a high-performance, inclusive culture.

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.

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.

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.