R & D Project Manager

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Full Time Professional Plymouth, MN, US

2 days ago Requisition

Salary Range: $ To $ Annually

Histo Sonics 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, Histo Sonics 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.

We offer an exciting work culture where cutting-edge science meets real-world application, and each team member’s contribution is important to our success in ensuring our physicians and their patients get what they need most.

Location: Hybrid - Plymouth, MN

Travel Requirement: Up to 10% travel

Position Summary (Why this role matters):

The R&D Project Manager, CONNECT is a dedicated operational partner to Histo Sonics' R&D CONNECT Program. This role is a system-level Project Manager scoped specifically to CONNECT's digital environment - the connectivity, remote system, portal, and data capabilities that extend the Edison System. This role manages the full scope of project coordination and execution for CONNECT and partners with the Program Director, who focuses on roadmap strategy, feature prioritization, and cross-program alignment, to keep execution aligned to that direction.

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 CONNECT's needs. A core part of this role is ensuring that CONNECT outputs - the System DHF, release deliverables, and data privacy/customer contract implementation - are tracked with enough rigor and transparency to inform release readiness and facilitate integration with the Edison System.

Depending on business needs, 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 CONNECT's operational cadence: maintain the CONNECT System DHF and release schedule, facilitate team status meetings, manage action tracking, and drive accountability across the cross-functional team. Ensure CONNECT documentation remains current, accessible, and consistent with Histo Sonics' design control standards.
• Maintain current and accurate status across CONNECT's DHF deliverables and release milestones - progress, priorities, risks, resource allocations, and target dates - escalating risks and constraints to the Program Director and Director of R&D Pipeline and Portfolio Management.
• Serve as system-level project manager for CONNECT across the DV lifecycle - building working knowledge of hardware upgrade kits, sourcing, manufacturing, and DV unit availability, and owning planning and implementation of DV and release cadences, including logistics, software configuration management, and cross-functional readiness across software, quality, regulatory, and systems engineering.
• Own planning and implementation of CONNECT field upgrades, partnering with the Technical Services team to prioritize customers and systems for upgrade sequencing.
• Drive CONNECT portal usage and adoption, developing and delivering training to internal teams.
• Partner with the Program Director to develop and maintain the CONNECT roadmap, ensuring release plans and system readiness are represented accurately to the Director of R&D Pipeline and Portfolio ahead of key roadmap and resourcing decisions.

External Partner & Cross-Functional Coordination

• Manage customer agreement implementation, partnering with Legal and Data Privacy teams to facilitate site-specific terms and conditions and any required implementation actions.
• Own global implementation activities related to market-specific data privacy requirements, assessing and managing their impact to the…