Software Project Manager

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.

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.