R & D Project Manager

HISTOSONICS•Plymouth, MN

23h•Hybrid

About The Position

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. 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 HistoSonics' 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.

Requirements

Bachelor's degree in computer science, software engineering, electrical engineering or other related disciplines.
10+ years of related experience in medical devices or other complex, regulated technical product development, including software or connected systems projects.
Background as a software developer, software engineering lead, or software project/program manager, with demonstrated experience owning cross-functional, system-level programs — spanning software, digital connectivity, and external partners — beyond single-release scope (e.g., DHF, data privacy, global deployment).
Working knowledge of database management and architecture concepts sufficient to assess system, portal, and data privacy impacts.
Strong understanding of medical device design controls, risk management (ISO 14971), software lifecycle standards (IEC 62304), and V&V processes.
Working knowledge of cybersecurity requirements for connected medical devices (e.g., premarket expectations, vulnerability management) sufficient to ensure they're addressed within CONNECT's development process — this role partners with dedicated security engineering resources rather than performing the technical work directly.
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.
Willingness to travel domestically up to 10%.

Nice To Haves

PMP certification or equivalent.
Certified Scrum Master (CSM, CSP-SM), PMI-ACP, or equivalent Agile certification; hands-on experience facilitating Agile ceremonies.
Experience managing customer agreements, HIPAA/GDPR, or other data privacy and regulatory data-handling frameworks in partnership with Legal and Data Privacy teams.
Experience planning and executing field deployment or upgrade programs for connected medical devices.
Familiarity with cloud platforms (Azure, AWS or Google Cloud) and DevOps/CI-CD practices.
Familiarity with imaging or other complex, multi-modality medical device programs.

Responsibilities

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 HistoSonics' 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.
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 CONNECT System DHF.
Partner with the HistoSonics Product Security and IT teams to ensure cybersecurity, infrastructure, and data management requirements are identified and incorporated into each CONNECT release.
Partner with the Edison System technical team to complete integration assessments for each CONNECT release, tracking dependencies on core platform development and shared architecture, and surfacing timeline or compatibility risks to the Program Director and the Director of R&D Pipeline and Portfolio.
Support the Director of R&D Pipeline and Portfolio in maintaining portfolio-level project tracking, resource planning visibility, and cross-program dependency mapping.
Contribute to standardized project management templates, status reporting formats, and governance frameworks used across R&D Programs.