HISTOSONICS INC

Lead planning, coordination, and execution of software releases ensuring cross-functional alignment. | Bachelor's degree and 10+ years experience in regulated industry with Agile and Jira proficiency required. | 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: Plymouth, MN or Ann Arbor, MI Position Summary (Why this role matters) The Software Project Manager leads the planning, coordination, and execution of software releases for the Edison system. This role drives cross-functional alignment across software engineering, quality, regulatory, product development, and systems engineering teams to deliver software releases and supporting documentation that meet business objectives, regulatory requirements, and program milestones. Key Responsibilities (What you’ll do) * Lead software project execution across feasibility, development, verification, validation, and release activities * Drive cross-functional alignment on scope, priorities, dependencies, and milestones to support successful software delivery * Coordinate day-to-day execution with a hands-on approach, engaging directly with teams to drive progress, remove blockers, and maintain alignment to sprint and release goals * Facilitate software project meetings, planning activities, release readiness reviews, and Agile ceremonies as needed * Coordinate cross-functional teams to ensure alignment on roles, priorities, scope, dependencies, and risks * Serve as the central point of contact for software projects, providing updates and escalating constraints to Product Development Leadership * Communicate clearly and proactively with stakeholders, tailoring messaging across technical, clinical, regulatory, and leadership audiences * Lead release readiness activities and reviews in accordance with the Software Development Process * Own the planning, tracking, and delivery of all software release documentation and DHF deliverables; ensure completeness, accuracy, and audit readiness across the full release lifecycle * Build and maintain project and release dashboards, defining and monitoring key metrics to provide real-time visibility into scope, progress, risks, and release readiness * Apply phase-gate and milestone-driven product development principles to ensure project documentation and processes meet regulatory requirements Qualifications and Skills * Bachelor’s degree in computer engineering, computer science, software engineering, or a closely related technical field * 10+ years of software engineering or project management experience in a regulated industry; preferably medical devices * 3+ years leading software delivery within Agile development teams * Experience planning and coordinating complex software releases involving multiple teams, dependencies, and regulatory deliverables * Certified Scrum Master (CSM, CSP-SM), PMI-ACP, or equivalent Agile certification preferred * Experience building project dashboards, defining success metrics, and tracking work using Jira, Azure DevOps, or similar tools * Proven ability to collaborate across matrixed organizations, communicate technical status and risks effectively, and drive alignment without direct authority * Understanding of phase-gate or milestone-based product development in regulated environments * Experience supporting FDA-regulated software development and familiarity with standards and regulations applicable to medical device software, including IEC 62304 * Exposure to manufacturing transfer, service deployment and post-market surveillance is a plus * Up to 10% domestic travel required 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.  #LI-Hybrid

Coordinate and manage complex, multi-workstream technology transformation programs with cross-functional teams. | Experienced in enterprise program management with strong stakeholder communication and delivery frameworks, but no direct medical device or design controls experience. | 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: 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. #LI-onsite