R&D Software 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.

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 

Position Summary (Why this role matters):

The Software Project Manager proactively leads the planning, coordination, and execution of medical device software development projects for the Edison system. This role is responsible for managing software projects from concept through commercialization, ensuring cross-functional alignment, regulatory compliance, and timely delivery. The Software Project Manager works with the Software Leadership team to identify resources, manage dependencies, meet schedule milestones, and adjust to complex project issues. This is a key contributor role and will be hands-on with regard to software development.

Key Responsibilities (What you’ll do):

• Lead execution of software projects across feasibility, prototyping, development, verification, and validation
• Own software release scope end-to-end, including definition, cross-functional alignment, communication, and formal scope change management
• Drive sponsor decision making when scope, schedule, or resources are at risk
• Lead 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 effective collaboration across cross-functional teams, ensuring clarity of roles, priorities, dependencies, and execution plans
• 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
• Translate complex technical and documentation status into clear, actionable insights that drive alignment and decision making
• Demonstrate understanding of phase-gate or milestone-driven product development, ensuring project documentation and processes meet regulatory compliance requirements

Qualifications and Skills: 

• Bachelor’s degree in computer engineering, computer science, software engineering, or a closely related technical field
• 5+ years of software development experience in a regulated industry; strong preference for medical device experience
• 3+ years of demonstrated success managing end-to-end software development lifecycle projects using Agile or Scrum methodologies and tools such as Jira or Azure DevOps
• Experience managing software releases and familiarity with Software as a Medical Device (SaMD) classification and lifecycle requirements strongly preferred
• Certified Scrum Master (CSM, CSP-SM), Agile Project Management, PMI-ACP, or equivalent preferred; demonstrated experience facilitating Agile ceremonies, promoting Agile values, and guiding teams toward high performance
• Experience building project dashboards, defining metrics, and using tools such as Azure DevOps or similar platforms to track and communicate program status
• Proven ability to collaborate within matrixed organizations and cross-site or global teams, partnering with software architects, software engineers, product development, quality assurance, and regulatory stakeholders
• Strong verbal and written communication skills, with the ability to translate complex technical status and risks into clear, concise messaging and drive alignment without authority
• Understanding of phase-gate or milestone-based product development in regulated environments
• Experience working with FDA medical software guidance, IEC 62304, HIPAA, GDPR, and other applicable regulations
• 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. 

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