HistoSonics, Inc.

You would oversee CROs, study timelines, and cross-functional deliverables while providing clinical and procedural expertise and supporting regulatory and marketing teams. | The role requires a scientific or clinical degree and 3–5+ years in medical device or preclinical research, with strong program management and external vendor study coordination 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: Remote Position Summary (Why this role matters): The Manager of Preclinical Operations & Program Coordination directs the operational execution of HistoSonics’ new-application preclinical portfolio, overseeing the flow of studies, contract research organizations (CROs), key opinion leader (KOL) engagements, and cross-functional deliverables across multiple concurrent indication programs. Reporting to the Director of Translational Medicine & New Applications, this role keeps programs on schedule and on scope by managing the execution of in vivo, ex vivo, and in vitro studies, owning CRO milestones and contracting status, leading KOL and lab activities, and ensuring that regulatory, clinical, and marketing functions receive the right inputs at the right time. The Manager also provides clinical, procedural, and translational context in cross-functional settings, supports physician education and medical affairs activities, and partners closely with the Preclinical Program Coordinator, who handles day-to-day tracking and logistics. This is a multidisciplinary role at the center of the preclinical program for a candidate who combines clinical insight with strong program management and follow-through. Key Responsibilities (What you’ll do): * Program leadership & coordination: Own the operational health of concurrent preclinical programs — setting master timelines, prioritizing across competing programs, anticipating dependency and schedule risks, and keeping studies, CROs, and internal stakeholders synchronized. Partner with the Preclinical Program Coordinator on tracking and logistics; review and act on CRO status, study progress, and indication-readiness trackers as decision-support tools. * Study execution support: Coordinate the planning and execution of preclinical studies — including proof of concept, effectiveness, safety, and biocompatibility (e.g., ISO 10993) testing — by managing logistics, documentation, scheduling, and deliverable tracking against development, regulatory, and clinical program requirements. Assist with protocol preparation, data collation, and study report turnaround. * CRO & vendor management: Manage day-to-day relationships and project execution with external partners, including CROs, from proof of concept through GLP confirmatory studies. Coordinate Statement of Work (SOW) execution under existing Master Service Agreements (MSAs), track contracting status, monitor budgets and pass-through costs, and serve as the operational liaison for study kickoffs, progress check-ins, and deliverable acceptance. * KOL & lab coordination: Organize and support engagement with internal and external subject matter experts across applications and specialties. Coordinate KOL meeting logistics, prepare briefing materials and leave-behinds, capture meeting notes and follow-ups, and help plan and run training events and labs (centers of excellence, MD training programs), and develop and deliver clinical training and educational content for physicians, advanced practice providers, and internal teams. * Cross-functional collaboration: Work closely with research and advanced development (RAD), product and new application development, upstream marketing, risk management, clinical, regulatory, and operations to ensure program progression and execution of key tasks and milestones — ensuring regulatory and clinical affairs functions have all required R&D deliverables and documentation on schedule. * Clinical context & team meeting participation: Attend and actively contribute to cross-functional team meetings, providing clinical context and translational perspective on the projects under discussion. Help connect study design, indication rationale, and clinical relevance for non-clinical stakeholders, ensuring decisions are grounded in the clinical realities of each application area and surfacing clinical considerations that may affect program direction. * Procedural & imaging expertise: Provide hands-on procedural and image-guidance expertise (e.g., ultrasound, CT, fluoroscopy) during animal labs, cadaver labs, and feasibility studies. Advise on procedural technique, peri-procedural care considerations, and clinical workflow; provide end-user feedback to RAD and product development teams; and contribute clinical input to risk management activities (e.g., use-related hazards and adverse event context). * Regulatory & clinical affairs support: Provide operational and documentation support for pilot/pivotal animal labs and for regulatory and clinical submissions, including GLP, Q-Sub, IDE, 510(k), De Novo, and/or PMA filings. Help assemble preclinical evidence packages and support feasibility and market-access study and protocol development, including clinical input on patient selection, peri-procedural care, and safety considerations. * Clinical & marketing support: Contribute to clinical landscape synthesis, indication rationale materials, and KOL/advisory network mapping (including leveraging professional society relationships to identify and engage clinical experts), and support upstream marketing with indication-readiness inputs and program status as needed. * Medical affairs & scientific exchange: Support scientific exchange with clinicians and KOLs, contribute to medical education materials and scientific presentations, and help communicate preclinical and clinical evidence accurately to internal and external audiences. Qualifications and Skills:  * Education: Degree in a relevant scientific, biomedical, engineering, or clinical field. A clinical/medical background and active license (e.g., RN, NP, PA, MD, or equivalent) is strongly preferred. Candidates with strong preclinical or program management experience and an appropriate scientific degree will also be considered. * Experience: Demonstrated experience in preclinical and/or clinical research and development, study coordination, or program/project management, preferably in medical devices or a regulated therapeutic environment. Experience coordinating CRO-conducted studies is strongly preferred. * Program management: Proven ability to manage multiple concurrent projects, maintain detailed timelines and trackers, anticipate dependencies, and drive tasks to completion across distributed teams and external partners. * Technical knowledge: Working knowledge of preclinical science and study conduct, including in vivo/ex vivo/in vitro methods, GLP and non-GLP study frameworks, and standards such as ISO 10993. Familiarity with the medical device product development and risk management process is preferred. * Clinical & procedural expertise: Hands-on experience in image-guided, interventional, or surgical procedures (e.g., interventional radiology, vascular, or cardiothoracic surgery) is strongly preferred. Experience in clinical education, protocol development, quality improvement, or professional society leadership, and medical affairs credentials (e.g., BCMAS), are a plus. * Regulatory familiarity: Exposure to regulatory submission support (Q-Sub, IDE, 510(k), De Novo, PMA) and to contracting structures (MSA/SOW) is advantageous. * Communication & organization: Excellent organizational, written, and cross-functional communication skills; strong attention to detail; and the ability to keep stakeholders aligned and informed in a fast-moving, multi-program environment.   Minimum Qualifications: * 3–5+ years of experience in industry, med tech, preclinical/clinical research, or program coordination, or equivalent clinical/procedural experience in a relevant specialty. * Experience supporting or coordinating studies across one or more indication/application areas (e.g.,oncology, urology, neurosciences, vascular, cardiac, general surgery, women’s health, or metabolic and degenerative diseases). 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-remote

Lead imaging operations for clinical research programs, managing imaging vendors and ensuring data integrity and regulatory compliance across clinical trial imaging. | Requires a bachelor's degree in life sciences or biomedical studies, at least 10 years of preclinical or clinical research experience, and expertise in imaging modalities and regulated vendor core labs. | 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: Remote - Contiguous United States Travel: 10-20% Position Summary: The Imaging Manager, Clinical Operations will lead imaging operations in support of our medical device research and development programs, spanning both preclinical studies and pre-market/postmarket clinical trial imaging data management. This individual will serve as the organization's subject-matter expert across multiple imaging modalities including ultrasound, MR, CT, fluoroscopy, angiography, and others. This individual will also manage, imaging platforms, vendors, and ensure data readiness for regulatory submission. This is a hybrid technical/operational leadership role. The ideal candidate combines hands-on imaging expertise with strong vendor and project management skills: equally comfortable evaluating an image read for quality, negotiating a core lab statement of work, or troubleshooting a repository access issue. Key Responsibilities: * Serve as the lead technical resource for all imaging modalities. * Oversee image acquisition and quality control, in support of device safety and performance studies. * Partner with study leads and R&D core teams to design imaging components of study protocols. * Author, revise, and maintain SOPs governing imaging procedures, equipment use, and data handling. * Support internal and external (sponsor, regulatory) audits related to imaging data and procedures. * Act as the primary imaging point of contact for internal stakeholders and CROs. * Communicate study progress, imaging findings, and technical constraints clearly to cross-functional and non-technical audiences. * Own the governance of the imaging repository: manage user access levels.  * Coordinate and plan for imaging software/platform updates, migrations, and vendor transitions, proactively managing read-delay and downtime risk. * Manage day-to-day core lab and imaging vendor performance against contracted deliverables. * Ensure required vendor documentation is complete and current: project plans, charters, image acquisition guidelines (IAGs), and training manuals. * Review statements of work (SOWs) and budgets for imaging core labs. * Track imaging submissions across all clinical study sites. * Monitor submission timelines against study milestones; proactively flag risk to deadlines. * Keep study teams informed of submission issues, delays, or timeline slips. * Verify that core lab activities are being conducted in accordance with study protocol requirements. * Track core lab turnaround times for reads, reports, and data transfers, and drive corrective action when performance lags. * Coordinate imaging data flow from sites → core lab → study database, ensuring a clean, traceable chain of custody. * Track missing, delayed, imaging and drive resolution with sites and vendors. * Ensure data integrity throughout the imaging data lifecycle. * Monitor image reads for quality and consistency across readers/sites. Qualifications and Skills: * Bachelor's degree in a life sciences, biomedical engineering, or related field (or equivalent experience). * 10+ years of hands-on experience in preclinical/clinical research, with substantial direct experience across multiple imaging modalities. * Demonstrated experience in a regulated research environment, ideally within medical devices, biotech, or a CRO setting. * Proven track record authoring SOPs and protocols, and training/mentoring technical staff. * Experience managing vendor core labs, and/or sponsor relationships, including reviewing statements of work and budgets. * Strong data integrity practices. * Comfort managing data flow and documentation across multiple systems/stakeholders (sites, core lab, internal database), including tracking timelines and escalating risk. * Excellent written and verbal communication skills; comfortable presenting technical findings to cross-functional and external audiences. * Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams). 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. #LI-Remote

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