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 or Ann Arbor, MI

Position Summary (Why this role matters)

The Software Project Manager leads the planning, coordination, and execution of software development programs and releases for the Edison system. This role drives cross-functional alignment across software engineering, quality, regulatory, product development, clinical, and systems engineering teams to deliver software products and releases that meet business objectives, regulatory requirements, and program milestones.

Success in this role requires experience leading software product development within FDA-regulated medical device environments.

Key Responsibilities

• Lead software project execution across feasibility, development, verification, validation, and release activities.
• Drive software release execution and cross-functional alignment on scope, priorities, dependencies, risks, and milestones to support successful software delivery.
• Facilitate software project meetings, release planning activities, quarterly planning, scrum of scrums, risk reviews, milestone reviews, release readiness reviews, and other Agile team ceremonies as needed.
• Own the planning, tracking, and coordination of software release documentation and DHF deliverables, ensuring completeness, traceability, and audit readiness.
• Serve as the central point of contact for software projects, providing updates and escalating constraints to Product Development Leadership.
• Ability to work through ambiguity in a growing software organization, flexing across project management, scrum facilitation, release coordination, and documentation as needed.
• Communicate clearly and proactively with stakeholders across technical, clinical, regulatory, and leadership audiences.
• Lead release readiness activities and reviews in accordance with the Software Development Process.
• Build and maintain project and release dashboards, defining and monitoring key metrics to provide visibility into scope, progress, risks, and release readiness.
• Apply phase-gate and milestone-driven product development principles to ensure project plans, documentation, and processes meet applicable quality and regulatory requirements.

Qualifications and Skills

Required

• Bachelor's degree or equivalent experience in a technical, engineering, scientific, business, or related field.
• 10+ years of experience in software project management, software program management, or related software development roles, including 3+ years supporting FDA-regulated medical device software product development.
• Experience planning and coordinating complex software releases involving multiple teams, dependencies, and regulatory deliverables.
• Demonstrated experience coordinating Design History File (DHF) deliverables, traceability, and audit readiness for FDA-regulated medical device software products.
• Experience leading software development activities including requirements management, verification, defect management, release planning, scrum of scrums, and design reviews.
• Experience developing medical device software in accordance with IEC 62304 and Design Control requirements.
• Experience using Azure DevOps or similar tools to plan, track, and communicate software development and release activities.
• Proven ability to collaborate across matrixed organizations, communicate technical status and risks effectively, and drive alignment without direct authority.
• Up to 10% domestic travel required.

Preferred

• Certified Scrum Master (CSM, CSP-SM), PMI-ACP, or equivalent Agile certification.

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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