R&D Software Project Manager

Histo Sonics 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, Histo Sonics 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 the execution of software projects, including feasibility, prototyping, development, documentation, verification and validation.

* Facilitate effective collaboration across program leaders, project managers, software development, test, and risk management resources.

* Engages with cross-functional teams to communicate and manage dependencies

* Monitor progress, oversee software configuration management, manage and produce documentation deliverables and escalate risks and impediments appropriately.

* Serve as a central point of contact for internal and external stakeholders, providing regular software project updates and status reports.

Qualifications and Skills:

* Bachelor's degree in computer engineering, computer science, software engineering or technical related field.

* 5+ years of software development experience in a regulated industry; strong preference for medical device experience.

* 3+ years of proven track record of managing full software development lifecycle projects, including complex electromechanical systems and software, in Agile environment.

* Direct experience in product development environments with software and firmware integration.

* Experience working in matrixed organizations or cross-site/global teams.

* Exposure to manufacturing transfer, service deployment and post-market surveillance is a plus.

* Experience with FDA medical software guidance, IEC
62304, HIPAA, GDPR and other applicable regulations.

* Understands phase-gate or milestone-based product development.

* 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.

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