R&D Project Manager

R&D Project Manager

HistoSonics is a commercial-stage medtech company advancing the Edison System, a novel non-invasive sonic beam therapy based on histotripsy. Since receiving FDA De Novo grant for the non-invasive destruction of liver tumors in 2023, the company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development. In addition to its current liver tumor indication, HistoSonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women's health, and other significant underserved human health areas, to realize the broader potential histotripsy across multiple disease states and medical specialties.

Location: Plymouth, MN (preferred); Madison, WI; or Ann Arbor, MI

Position Summary (Why this role matters):

The R&D Project Manager is a dedicated operational partner to an R&D Program, responsible for managing the full scope of project coordination and execution for their assigned Program. HistoSonics' Programs focus on early feature definition, technical investigation, and de-risking, encompassing multiple feature and technology workstreams executing in parallel at various stages (feasibility, definition, on-deck, and implementation) in preparation for formal integration into the product. This role manages the operations and coordination of all Program activities and partners with the Program Director that focuses on roadmap strategy, feature prioritization, clinical and technical insight synthesis, and cross-program alignment.

This role reports to the Director of R&D Pipeline and Portfolio Management to ensure consistent methodology and portfolio visibility, while dedicating most of their time to their assigned Program's needs. A core part of this role is ensuring that Program outputs de-risking status, open risks, and documented findings are tracked with enough rigor and transparency to inform Project scope decisions and facilitate handoff to System Integration Project teams. Depending on Program assignment and business need, this role may also support portfolio-level project management for the Director of R&D Pipeline and Portfolio, including communication of project updates, resource analysis, and portfolio visibility.

Key Responsibilities (What you'll do):

Program Operations & Coordination

• Own the assigned Program's operational cadence: maintain the master schedule or feature tracker, facilitate team status meetings, manage action tracking, and drive accountability across the cross-functional team. Ensure Program documentation remains current, accessible, and consistent with HistoSonics' design control standards.
• Maintain current and accurate status across the Program's tracked features and workstreams progress, priorities, risks (execution, technical, and patient safety), resource allocations and hiring plans, and target dates flagging risks and priority constraints to the Program Director and Director of R&D Pipeline and Portfolio.
• Coordinate logistics needed to keep the Program moving which may include hardware deployment and build status, lab scheduling, resource allocations, or kickoff readiness for upcoming workstreams, depending on the Program's needs.
• Partner with the Program Director to ensure new feature readiness is represented accurately to the Director of R&D Pipeline and Portfolio ahead of Project scope decisions, supporting credible scenario modeling of what is ready, and support a clean handoff of scoped features to the System Integration Project team.

External Partner & Cross-Functional Coordination

• For Program activities involving external development partnerships, act as the operational point of contact by managing partner meeting cadences, preparing agendas and pre-reads, documenting decisions and action items, and tracking deliverables against commitments. Coordinate requirements handoffs between the Program team and these partners or internal cross-functional owners, ensuring the Program Director's direction is clearly operationalized in their workplans.
• Monitoring external and cross-functional partners' progress, proactively surface risks when external timelines or deliverables could affect Program readiness.

Clinical or Preclinical Case Series & User Insight Pipeline (where applicable)

• Coordinate the logistics of Program-related clinical or preclinical case series or feasibility activities: contracting, protocol development, site scheduling, system readiness, data capture follow-up, and clinical site communications. Drive required design documentation for the respective clinical case series.
• Maintain a structured log of clinical observations and physician feedback from case series or evaluation activities, ensuring insights are surfaced to the Program Director for requirements translation, and coordinate data collection efforts across clinical or field sites needed to support other program activities.

Cross-Program Dependency Management

• Track and manage the assigned Program's dependencies between features within the Program, on other Programs, Core platform development, or shared architecture coordinating with Project Managers from other Programs where dependencies span multiple Programs and surface timeline risks to the Program Director and the Director of R&D Pipeline and Portfolio.

Portfolio-Level Project Management Support

• Support the Director of R&D Pipeline and Portfolio in maintaining portfolio-level project tracking, resource planning visibility, and cross-program (and project) dependency mapping.
• Contribute to the development and ongoing maintenance of standardized project management templates, status reporting formats, and governance frameworks used across R&D Programs. Use these formats to prepare and distribute regular Program-level communications, pre-reads, and forum materials.
• Assist in preparation of executive-level portfolio reviews and R&D leadership reporting, compiling Program performance data into consistent, decision-ready formats, and helping identify resource gaps, schedule risks, and bottlenecks that require escalation or leadership decisions.

Qualifications

Required:

• Bachelor's degree in engineering, science, or related technical field.
• 10+ years of experience in medical device product development.
• Demonstrated experience managing cross-functional teams on complex, system-level programs involving hardware, software, and/or external partners.
• Strong understanding of medical device design controls, risk management (ISO 14971), and V&V processes.
• Excellent organizational, communication, and stakeholder management skills; able to synthesize complexity into clear status and risk communications.
• Proficiency in project management tools (e.g., MS Project, Smartsheet, Jira, Azure DevOps) and collaboration platforms.

Preferred:

• PMP certification or equivalent, and experience managing or coordinating external design and development partnerships.

Benefits: We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

U.S. Work Authorization & Sponsorship: Employer will not sponsor visas for position.

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