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
Travel: up to 10%
Position Summary (Why this role matters):
The Software Project Manager proactively leads the planning, coordination, execution, and release of medical device software development projects for the Edison system. This role is responsible for managing software projects from concept through commercialization, including on-device product software applications and services, connectivity services, and Cloud-based data analysis solutions. This role owns the end-to-end software release lifecycle — from release scope definition through deployment — ensuring cross-functional alignment, regulatory compliance, and timely delivery. The Software Project Manager works with the Product Development Leadership team to identify resources, manage dependencies, meet schedule milestones, and adjust to complex project issues.
Key Responsibilities (What you’ll do):
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Partners with the Product Development Program Director(s) and Software Architect(s) to maintain Program Roadmaps of new features and monitor new feature feasibility readiness for upcoming software releases.
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Define and maintain software release scope in collaboration with Product Engineering, Program Management, Software Architecture, Software Leadership, and Marketing; manage scope change requests through formal review processes
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Owns the software release scope, including overall communication and formal scope change reviews for the software release.
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Responsible for driving project sponsor decision making when scope, schedule and/or resources are at risk.
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Lead the execution of software projects, including feasibility, prototyping, development, design history file documentation, verification and validation.
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Facilitate effective collaboration across program leaders, project managers, product engineers, software architects and developers, test, and risk management resources.
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Engages with cross-functional teams to communicate and manage dependencies
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Serve as a central point of contact for software projects, providing regular project updates and escalating constraints to Product Development Leadership.
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Communicate clearly and proactively with all stakeholders — adapting messaging to technical, clinical, regulatory, and leadership audiences — and demonstrate flexibility when priorities shift in a fast-paced medical device environment.
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Monitor progress, oversee software configuration management, manage and produce documentation deliverables and escalate risks and impediments appropriately.
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Lead release readiness activities and reviews in accordance with the Software Development Process
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Understanding of phase-gate or milestone-driven product development, with the ability to ensure project documentation and processes meet regulatory compliance requirements.
Qualifications
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Bachelor’s degree in computer engineering, computer science, software engineering, or a closely related technical field.
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5+ years of software development experience within medical devices or other highly regulated industries.
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3+ years of demonstrated success managing end-to-end software development lifecycle projects, including cloud-hosted SaaS or connected applications, using Agile/Scrum methodologies and tools such as Jira or Azure DevOps.
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Experience managing software releases that span device-side and cloud-side components, with familiarity in data pipeline, analytics, or reporting software; experience with Software as a Medical Device (SaMD) classification and lifecycle requirements is strongly preferred.
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Strong understanding of cloud computing platforms, technologies, and best practices across major providers (AWS, Azure, or Google Cloud).
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Working knowledge of networking, security protocols, and database management concepts in cloud environments.
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Familiarity with DevOps principles and CI/CD pipelines for cloud-based application deployment.
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Certified Scrum Master (CSM, CSP-SM), Agile Project Management, PMP, PMI-ACP, or equivalent preferred. Hands on experience facilitating Agile ceremonies, promoting Agile values, and guiding teams toward high performance.
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Experience collaborating within matrixed organizations and cross-site or global teams, partnering with software architects, data scientists, engineers, quality assurance, and regulatory stakeholders.
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Exceptional verbal and written communication skills, with the ability to translate complex technical status and risks into clear, concise messaging for diverse stakeholders; demonstrated ability to build relationships, influence without authority, and drive alignment in a cross-functional environment.
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Experience working with FDA medical software guidance, IEC 62304, HIPAA, GDPR, and other applicable regulations.
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Exposure to manufacturing transfer, service deployment, and post-market surveillance activities is preferred.
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Willingness to travel domestically up to 10%.
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.
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